Skin barrier protection delivery system and method

Abstract

The present disclosure relates to compositions and methods for treating topical skin conditions. Topically applied compositions and delivery systems are also provided. Methods of using the compositions and delivery systems in cosmetic, personal care and dermatological applications are also provided. Sprayable compositions comprising petrolatum are also provided.

Description

[Technical field]

[0001] 1. Cross reference This application claims the benefit of U.S. Provisional Patent Application No. 63 / 333,768, filed April 22, 2022, and U.S. Provisional Patent Application No. 63 / 434,179, filed December 21, 2022, the contents of each of which are incorporated by reference in their entirety herein.

[0002] 2. Field The present disclosure relates to compositions and methods for treating topical skin conditions. Topically applied compositions and delivery systems are also provided. Additionally, methods of using the compositions and delivery systems in cosmetic, personal care and dermatological applications are provided. Compositions in the form of sprayable gels are also provided. [Background technology]

[0003] 3.Background Skin is the largest organ of the body and protects mammalian organisms from both aqueous and dry surrounding environments. It is now generally accepted that the intercellular lamellar bilayer sheet of stratum corneum lipids is a key component of the functional barrier. Maintenance of the barrier against excessive transepidermal water loss to the environment is important for the survival of all terrestrial animals. Local or systemic disruptions of the epidermal barrier occur in various diseases and conditions of the skin and mucous membranes. These disruptions not only contribute significantly to the morphology of skin lesions but also activate certain skin diseases.

[0004] Active agents are used in the skin treatment of a wide variety of skin conditions, such as psoriasis, photoaging, age spots, aged appearance of skin due to exogenous and endogenous causes, skin wrinkles, acne, hyperpigmentation and skin cancer. Active agents are typically prescription active agents and non-prescription active agents. The solvents used in dermatological formulations with skin treatment active agents can be strong solvents, such as acetone, or mild, i.e., not strong, solvents. However, strong solvents are known to cause skin condition effects that require additional treatment, including disruption of the skin barrier, and may prevent patients from complying with skin treatment regimens. On the other hand, mild solvents are known to be ineffective in the delivery of active agents in transdermal and dermal applications. Furthermore, with the current trend toward long-term use of dermatological formulations in skin care, there is a continuing need for topical formulations of active agents for various skin treatments.

[0005] Common moisturizers and emollients also cause disruption of barrier function. There has been and remains a need for cosmetically elegant, non-greasy, safe and effective topical compositions that not only protect the skin barrier but also effectively and safely deliver other functional and / or pharmacologic active ingredients to the skin. Summary of the Invention

[0006] 4. Overview One of the objectives of the present disclosure is to provide a cost-effective composition, such as a smooth, non-sticky, sprayable composition, that is easy and hygienic to apply. In one embodiment, the composition increases water retention, improves skin roughness (moisturization), repairs skin, and protects against harmful conditions.

[0007] Certain skin care formulations disclosed herein provide surprising and unexpected results. In certain embodiments, the disclosed delivery systems include certain components that provide additive or synergistic results.

[0008] Provided in the present disclosure are compositions useful as skin moisturizers, skin emollients, skin debridements, and the like, as well as base compositions for cosmetic formulations, compositions for therapeutic agents, e.g., pharmacological formulations. In cosmetic formulations, the compositions can be used with additional ingredients that are simply cosmetic. Alternatively, cosmetic formulations can include ingredients that are both cosmetically active and therapeutically active, e.g., "cosmeceutical" ingredients.

[0009] In one embodiment, disclosed herein is a composition that corrects defective epidermal barrier in skin or mucous membrane disease or condition.The disclosed compositions and methods strengthen the barrier and prevent its destruction by environmental damage.The disclosed compositions are useful as moisturizing agents for softening and hydrating the epidermis, and have a neutral effect on barrier function, and in some cases improve barrier function or increase its recovery rate.

[0010] The disclosed compositions also enhance the therapeutic activity of other pharmaceutical agents, including anti-inflammatory agents, antimicrobial agents, antitumor agents, antipruritic agents, antihistamines, analgesics, natural and synthetic vitamin analogs, carboxylic acids and their analogs, and artemisinin and its analogs.

[0011] Through their effect on epidermal barrier function, the disclosed compositions improve epidermal hyperproliferation and reduce inflammation, which results in significant long-term or complete remission and prevents recurrence of skin disorders.

[0012] In certain embodiments, the skin barrier protection delivery system comprises a sprayable petrolatum that retains a higher concentration of active ingredient without separation. It has been unexpectedly discovered that a composition comprising at least about 30% by weight of petrolatum can be formulated as a spray. Furthermore, it has been unexpectedly discovered that a formulation having a high concentration of petrolatum as in the present disclosure can be easily and efficiently sprayed, providing a uniform coverage on the skin. In certain embodiments, the sprayable formulation does not contain propellant gas as an additive that may be harmful to the subject. In one embodiment, the composition forms an occlusive film on the skin.

[0013] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration of at least 30% by weight, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0014] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-65% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30% by weight, and the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0015] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, the combined concentration of coconut alkane and coco-caprylate / caprate being up to 70% by weight, and (ii) petrolatum, the petrolatum being present in a concentration of at least 30% by weight, and the delivery system being sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0016] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration range of 25-60% by weight, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0017] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of coconut alkane in a concentration range of 30-65% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration range of 25-60% by weight, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0018] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, the combined concentration of coconut alkane and coco-caprylate / caprate being up to 70% by weight, and (ii) petrolatum, the petrolatum being present in a concentration of 25-60% by weight, and the delivery system being sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0019] In some embodiments, the skin barrier protection delivery system of the present disclosure contains at least one, at least two, at least three, or at least four of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes (e.g., squalene), plant-based esters or waxes, tocopherols, and / or phospholipids. In some embodiments, petrolatum is present at a concentration of 25-60% by weight. In some embodiments, petrolatum is present at a concentration of at least 30% by weight. In some embodiments, petrolatum is present at a concentration of 40% by weight. In some embodiments, petrolatum is present at a concentration of 50% by weight.

[0020] In some embodiments, the skin barrier protection delivery system of the present disclosure contains a plant-based ester or wax. In some embodiments, the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax, and sunflower wax. In some embodiments, the plant-based ester or wax comprises jojoba esters.

[0021] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises a terpene. In some embodiments, the terpene is selected from the group consisting of triterpene, hemiterpene, monoterpene, sesquiterpene, diterpene, sesterterpene and tetraterpene. In some embodiments, the terpene is a triterpene, for example squalene.

[0022] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises phytosterol esters, including esters derived from seed oils or nut oils.In some embodiments, the seed oils or nut oils are selected from the group consisting of macadamia oil, almond oil, avocado oil, canola oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine seed oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil, and walnut oil.In some embodiments, the phytosterol ester is phytosteryl macadamiate.

[0023] In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide, triglyceride, phytosterol, phytosterol macadamiate, squalene, jojoba esters, and tocopherol. In some embodiments, the skin barrier protection delivery system includes ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglyceride, and C12-18 acid triglyceride.

[0024] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one of a polysaccharide, a gum, a buffer (eg, an acid), and a botanical extract (eg, a root plant extract).

[0025] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises a polysaccharide. In some embodiments, the polysaccharide is selected from the group consisting of maltodextrin, cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid, and mixtures thereof. In some embodiments, the polysaccharide is maltodextrin.

[0026] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises a gum. In some embodiments, the gum is selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar-agar gum, carrageenan gum, gellan gum, gum arabic, and gum tragacanth. In some embodiments, the gum is Acacia Senegal gum.

[0027] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises an extract derived from a plant. In some embodiments, the extract is derived from a root plant. In some embodiments, the root plant is selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish. In some embodiments, the root plant extract is sweet potato (Ipomoea Batatas) root extract.

[0028] In some embodiments, the skin barrier protection delivery system of the present disclosure includes a buffering agent. In some embodiments, the buffering agent is an acid. In some embodiments, the acid is citric acid. In some embodiments, the acid is lactic acid.

[0029] In some embodiments, the disclosed skin barrier protection delivery system comprises at least one of Ipomoea Batatas root extract, citric acid, Acacia Senegal gum, and maltodextrin. In some embodiments, the disclosed skin barrier protection delivery system comprises Ipomoea Batatas root extract, citric acid, Acacia Senegal gum, and maltodextrin.

[0030] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato (Ipomoea Batatas) root extract, gum arabic (Acacia Senegal), citric acid, and maltodextrin.

[0031] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) at least 30% by weight petrolatum; (ii) coconut alkane in the range of 30-70% by weight; (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NP in the range of 0.01-0.1% by weight; (v) ceramide AP in the range of 0.01-0.1% by weight; (vi) jojoba esters in the range of 0.1-1.5% by weight; (vii) glyceryl esters in the range of 0.1-1% by weight. (viii) squalene in the range of 0.01 to 0.1% by weight; (ix) phytosterols in the range of 0.005 to 0.1% by weight; (x) tocopherols in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5 to 5% by weight; (xii) C12-18 acid triglycerides in the range of 0.1 to 1% by weight; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) maltodextrin in the range of 0.001 to 0.1% by weight. In some embodiments, the delivery system is a sprayable formulation. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0032] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) 50% by weight petrolatum; (ii) 42-43% by weight coconut alkane; (iii) 4-5% by weight coco-caprylate / caprate; (iv) 0.05% by weight ceramide NP; (v) 0.05% by weight ceramide AP; (vi) 0.75% by weight jojoba esters; (vii) 0.3-0.4% by weight squalene; (viii) 0.05-0.06% by weight phytosteryl macadamiate; (ix) 0.01-0.02% by weight phytosterol; (x) 0.0045% by weight tocopherol; (xi) 1-2% by weight C18-36 acid triglyceride; (xii) 0.4-0.5% by weight C12-18 acid triglyceride; (xiii) 0.03-0.04% by weight sweet potato (ipomoea batatas) root extract; (xiv) 0.003-0.004% by weight citric acid; (xv) 0.03-0.04% by weight Acacia Senegal gum; and (xvi) 0.03-0.04% by weight maltodextrin. In some embodiments, the delivery system is a sprayable formulation.

[0033] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises zinc oxide. In some embodiments, the zinc oxide is present in a concentration range of about 10% to about 15% by weight. In some embodiments, the zinc oxide is present in a concentration range of about 10% to about 25%. In some embodiments, the zinc oxide is about 15%.

[0034] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) 25-60% by weight petrolatum; (ii) 10-25% by weight zinc oxide (ZnO); and (iii) 30-60% by weight isohexadecane.

[0035] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 40% by weight petrolatum, (ii) 15% by weight zinc oxide (ZnO), and (iii) 45% by weight isohexadecane.

[0036] In some embodiments, the skin barrier protection delivery system of the present disclosure has a viscosity of about 500 cps to about 10,000 cps, for example, about 1,000 cps to about 5000 cps.

[0037] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises an active ingredient as described herein, in some embodiments, the active ingredient is present in an amount of about 0.0001% to about 35% by weight.

[0038] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises a pharma- ceutically acceptable carrier or excipient, hi some embodiments, the pharma- ceutically acceptable carrier or excipient is selected from the group consisting of water and oil emulsions, suspensions, colloids, microemulsions, clear solutions, suspensions of nanoparticles, emulsions of nanoparticles, and anhydrous compositions.

[0039] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a spray comprising a skin barrier protection delivery system as described herein. In some embodiments, the composition does not contain a propellant.

[0040] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a sprayable gel comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the composition does not include a propellant, aerosol or bag-on-valve.

[0041] In some embodiments, the compositions of the present disclosure do not contain flammable components. In some embodiments, the compositions of the present disclosure do not include flammable solubilizers. In some embodiments, the compositions of the present disclosure do not include alcohol.

[0042] In some embodiments, the present disclosure provides a device comprising the skin barrier protection delivery system of the present disclosure.

[0043] In some embodiments, the present disclosure provides a device comprising a pharmaceutical composition comprising the skin barrier protection delivery system of the present disclosure.

[0044] In some embodiments, the device does not include a propellant or aerosol or a bag-on-valve. In some embodiments, the device is in the form of a sprayer pump. In some embodiments, the device is a dip tube sprayer pump.

[0045] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising: (i) a long chain alkane having a carbon length greater than 10 carbons in a concentration range of 30-70% by weight; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30% by weight, and wherein the delivery system is sprayable.

[0046] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising: (i) a mixture of a long chain alkane having a carbon length greater than 10 carbons in a concentration range of 30-70% by weight and an ester of a long chain alcohol in a concentration of 3-7% by weight; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30% by weight, and the delivery system is sprayable. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] 5. Detailed Description Stable, non-irritating skin treatment active agent containing formulations and delivery systems for topical application to the skin are disclosed. The disclosed topical formulations and delivery systems provide controlled, gentle release of active agent to the skin for the treatment of acceptable skin conditions and for the improvement of aesthetic skin properties. Methods for formulating, manufacturing, and using the disclosed formulations and delivery systems are also provided. Petrolatum is not known to have been previously utilized in non-aerosol (non-propellant-based) spray formulations, which are meant to be dispensed via manual spray pump dispensers, due to the high viscosity of petrolatum. Furthermore, the percentage of petrolatum required to achieve skin protection benefits is too high, and thus the use of petrolatum can clog spray pumps. As a result, liquid or semi-solid (e.g., gel) compositions are either not sprayed at all or sprayed inefficiently by sputtering through the orifice, leaving a very uneven coating on the skin. If any formulations contain petrolatum, the formulations did not contain a sufficient amount of petrolatum to provide the necessary skin protection benefits. It has been unexpectedly discovered that formulations having high concentrations of petrolatum (e.g., 30% by weight or more) as disclosed herein can be easily and efficiently sprayed to provide a uniform coverage on the skin. In certain embodiments, the sprayable formulation does not contain propellant gas as an additive that may be harmful to the subject.

[0048] In certain embodiments, the formulations disclosed herein i) allow for a 10-50 fold reduction in the use of key ingredients, ii) are therefore better for the environment, iii) the formulations leave a silky smooth feeling on the skin versus the sticky, greasy and dirty feeling obtained with known formulations and pure petrolatum jelly for the same or better therapeutic effect, and iv) the formulations are sprayable which significantly: 1) provides increased ease of use (at home as well as hospital and nursing home environments (e.g., one nurse vs. two nurses) and 2) provides increased protection against bacterial cross-contamination (no fingers-spatula in the jar). The sprayable formulations may be applied to the skin surface without the need to touch or rub the skin surface. Thus, the risk of infection or contamination is reduced. In certain embodiments, provided herein is the surprising discovery of a composition comprising a high percentage (e.g., 30% by weight or more) of petrolatum in a sprayable form having improved sprayability compared to existing compositions comprising petrolatum.

[0049] The present disclosure provides skin care formulations, delivery systems and methods of use thereof for treating, alleviating or improving skin conditions suitable for treatment with active ingredients. Acceptable conditions include, but are not limited to, inflammatory disorders of the skin and skin conditions characterized by increased cell turnover, including psoriasis, photoaging, weathered appearance, yellowing, loss of elasticity, loss of collagen-rich appearance and / or youthfulness, redness, dryness, age spots, wrinkled skin, acne, rosacea, ichthyosis, xerosis, diaper rash, dermatitis, cracked skin on hands and feet, and skin cancer.

[0050] The compositions of the present disclosure may also be used as healing agents for minor scrapes and burns, moisturizers for the face, hands, or feet, etc., protective barriers for pet paws, diaper rash, eye make-up removers, split end reducers, prevention of skin staining from hair dyes or nail polish, fragrance preservatives, and lubricants for stuck objects.

[0051] The disclosed formulations are also useful for improving one or more aesthetic criteria, including, but not limited to, the perceived improvement of apparent skin age, skin tone, weathered appearance, yellowing, loss of elasticity, redness, dryness, age spots, skin wrinkles, skin smoothness, brightness, radiance, and reduced appearance of skin pores.

[0052] As used herein, the term "about" refers to + / - 5% of the specified value.

[0053] As used herein, the term "treatment" or "treating" in relation to a skin condition generally refers to administration intended to produce a pharmacodynamic effect, regardless of outcome. In certain embodiments, "treatment" or "treating" means "having a positive effect on a skin condition" and includes reducing, improving, and / or alleviating at least one symptom of the skin condition, reducing, improving, and / or alleviating the severity of the skin condition, delaying, preventing, or inhibiting the progression of the skin condition, or any improvement or benefit recognized as a result of treatment. It may also mean achieving a treatment result that is comparable to or better than the treatment result of a prescription drug with a non-prescription product. Thus, treatment, as used herein, does not require a complete cure of the condition. In certain embodiments, the formulation or delivery system of the present disclosure may reduce the severity of the skin condition, reduce the severity of symptoms associated therewith, provide an improvement in the patient's quality of life, or delay, prevent, inhibit, or provide a perceived benefit from the onset of one or more symptoms of the skin condition. As used herein, these terms also include aesthetic improvements to the skin upon application of the disclosed active agent-containing formulations.

[0054] As used herein, "wt %" with respect to a component or combination of components in the disclosed formulations means the concentration of that component or combination of components by weight based on the total weight of the formulation.

[0055] As used herein, the terms "application", "apply" and "applying" with respect to the disclosed topical formulations or the method of using the disclosed topical formulations refer to any manner of administering the topical formulation to the skin of a patient in medical or cosmetic practice that delivers the formulation to the skin surface of a patient. Smearing, rubbing, spreading, spraying the disclosed topical formulations on the skin of a subject with or without the aid of a suitable device are all included within the scope of the term "application" as used herein. The term "topical" or "topically" with respect to administration or application of the disclosed formulations refers to administration or application on the skin, or administration onto the skin.

[0056] As used herein, the phrases "effective amount" or "therapeutically effective amount," as used interchangeably herein, refer to an amount of a formulation or its components effective to alleviate or improve skin conditions as described above, including, but not limited to, detectable local improvement in the area of ​​topical application, to reduced or improved symptoms such as reduced sensitivity to free radical damage from sunlight (UVB, UVA, visible light), HEV (blue) light, infrared (IR), pollution, irritants, allergens, or various environmental toxins, apparent skin age, radiation damage, sun or UV damage, skin tone, weather appearance, yellowing, appearance of fine lines, rough skin, sagging skin, firmness of skin, dryness, rashes, dry skin ... Effects include a range of effects ranging from substantial relief of symptoms to improvement of one or more aesthetic criteria, including but not limited to the following: wrinkles, skin wrinkles, skin smoothness, brightness, radiance, and perceived improvement of skin pores, hyperpigmentation, scars, skin surface irregularities, rosacea, acne, psoriasis, skin regeneration and renewal process, redness, ichthyosis, severity of photodamage, lack of smoothness to touch, lack of smoothness to sight, lack of softness, lack of lightness, lack of radiance, skin texture, fine facial wrinkles, crow's feet, pigmentation disorders, wrinkled skin texture, reduced skin elasticity, and other damaging skin conditions. Effective amounts may vary with the particular condition(s) being treated, the severity of the condition, the duration of treatment, the particular components of the composition used, and other factors. In certain embodiments, the disclosed compositions and formulations provide a method for stabilizing and delivering active agents to the skin in an effective manner. Certain disclosed compositions, formulations, delivery systems, and methods of use thereof may reduce, minimize, or eliminate commonly observed skin conditions, including itching, severe peeling, skin barrier destruction, discomfort, extreme dryness, cracked skin, and sensitization, among others. In certain embodiments, the disclosed compositions, formulations, delivery systems, and methods of use thereof also provide aesthetic improvements in the skin, including, but not limited to, younger-looking skin, skin that exhibits a more even tone, skin with less noticeable pores, and skin that is judged by the user to be smoother, and / or skin that is judged by the user to be improved in terms of its weathered or aged appearance, yellowing, loss of elasticity, redness, dryness, age spots, and / or skin wrinkles.

[0057] In certain embodiments, the delivery system disclosed herein not only maintains product stability, including the stability of formulated active agents.In certain embodiments, the inventors have surprisingly found the effectiveness of certain disclosed formulations compared to other skin care formulations.Thus, certain disclosed formulations and their methods of use work effectively in skin care treatments at non-prescription strength compared to prescription strength active agents.In certain embodiments, the formulation reduces, minimizes, or does not cause any skin irritation and other possible side effects typically associated with such formulations, especially in daily long-term use.

[0058] Without wishing to be bound by theory, it is contemplated that the unexpected results associated with certain embodiments of the formulations are obtained through the synergistic effect of the delivery systems herein, i.e., the ability of the delivery systems to provide controlled release of the active agent, in which the disclosed formulations of certain embodiments release the active agent at maximum, optimal intensity and release rate with minimal or no skin irritation.

[0059] Without wishing to be bound by theory, it is contemplated that in certain embodiments, the increased delivery efficiency of active agents, together with the significant reduction in irritation observed when administering the formulations disclosed herein, allows the formulation and use of delivery systems with significantly higher concentrations of active ingredients than those previously used.In this way, certain disclosed formulations and delivery systems provide effective skin care treatment at non-prescription strength, while being gentle to the skin and well tolerated by consumers.

[0060] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising petrolatum. In some embodiments, the petrolatum is present in a concentration of at least 30% by weight. In some embodiments, the petrolatum is present in a concentration range of 25-60% by weight. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0061] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration of at least 30% by weight. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable liquid, semi-liquid, or gel.

[0062] In some embodiments, provided herein is a skin barrier protection delivery system comprising (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration range of 25-60% by weight, wherein the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0063] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-65% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration of at least 30% by weight. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0064] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-65% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, and (ii) petrolatum present in a concentration range of 25-60% by weight, and the delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0065] It is understood that the mixture of coconut alkane and coco-caprylate / caprate in the composition of the present disclosure is present in a concentration of up to about 70 by weight of the formulation. In some embodiments, the present disclosure comprises (i) a mixture of coconut alkane and coco-caprylate / caprate, the combined concentration of coconut alkane and coco-caprylate / caprate being up to 70% by weight, and (ii) petrolatum present in a concentration of at least 30% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0066] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, the combined concentration of coconut alkane and coco-caprylate / caprate being up to 70% by weight, and (ii) petrolatum present in a concentration of 25-60% by weight, the delivery system being sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0067] In some embodiments, the skin barrier protection delivery system comprises (i) a mixture of coconut alkane in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight, the combined concentration of coconut alkane and coco-caprylate / caprate being up to 70% by weight, and (ii) petrolatum present in a concentration of at least 30% by weight. In some embodiments, the skin barrier protection delivery system is a sprayable composition. In some embodiments, the skin barrier protection delivery system is in the form of a sprayable gel.

[0068] Vaseline Petrolatum is a combination of hydrocarbons obtained as a semi-solid from the dewaxing of paraffinic residual oils. Petrolatum contains primarily saturated crystalline and liquid hydrocarbons, primarily with carbon chain lengths of C25 and above.

[0069] Vaseline is generally a safe and effective topical agent suitable for use in a wide range of topical applications, including but not limited to moisturizing creams and lotions, makeup, hand and foot creams and lotions, skin protectants, wound care, lip balms and lipsticks, ointments and scrubs, baby care, and hair care.In medicine, Vaseline is used as a medicinal pain reliever, ointment, and cream.Vaseline can help protect damaged or exposed skin or mucosal surfaces from harmful irritation and provide relief to such surfaces.More specifically, such products can help prevent (or temporarily protect, and optionally help relieve) chapped, rough, or cracked skin.

[0070] Lip products containing petrolatum in concentrations recognized as safe and effective by the FDA in its final skin protection monograph may claim as a benefit that they temporarily prevent dryness and help reduce cracking of the exposed surfaces of the lips.

[0071] Both skin and lip products containing more than 30% petrolatum may also claim to help protect the skin / lips from the drying effects of wind and cold weather.

[0072] Despite their long history of safety and effectiveness, petrolatum-based topical formulations are known to have certain limitations - namely, they can be oily and cosmetically unrefined.

[0073] Application of topical products by a user introducing their hands or inanimate applicators (brushes, spatulas, swabs, sponges, puffs) into a container can be unhygienic and have potentially adverse health consequences. Even if "clean" (e.g., free of exogenous contaminants or disease carriers), hands can contain microorganisms present in the skin microbiome. Applicators are often not washed between uses and can become colonized by microorganisms.

[0074] There has been and still is a need for a cosmetically elegant, non-greasy, and in certain embodiments sprayable composition that applies at least 30% by weight of safe and effective concentration of petrolatum and other ingredients to not only protect the skin barrier but also effectively and safely deliver other functional and / or pharmacologic active ingredients to the skin.These needs are met by the skin barrier protection delivery system of the present disclosure.Therefore, one of the objectives of the present disclosure is to increase water retention and improve skin roughness (moisturization).

[0075] In some embodiments, petrolatum is present in the skin barrier protection system of the present disclosure at a concentration of at least about 30% by weight. In some embodiments, petrolatum is present in the skin barrier protection system of the present disclosure in a concentration range of about 25% to about 30%, about 25% to about 60%, about 30% to about 60%, about 30% to about 55%, about 30% to about 50%, about 30% to about 45%, about 30% to about 40%, about 30% to about 35%, about 35% to about 60%, about 35% to about 55%, about 35% to about 50%, about 35% to about 45%, about 35% to about 40%, about 40% to about 60%, about 40% to about 55%, about 40% to about 50%, about 40% to about 45%, about 45% to about 60%, about 50% to about 60%, about 50% to about 55%, or about 55% to about 60%. In some embodiments, petrolatum is present in the skin barrier protection system of the present disclosure at a concentration of at least about 25%, 30%, 35%, 40%, 45%, 50%, 55%, or 60% by weight, or even higher. In some embodiments, petrolatum is present at a concentration of 40% by weight. In some embodiments, petrolatum is present at a concentration of 50% by weight.

[0076] Coconut Alkanes and Coco-Caprylates / Caprates Coconut alkanes are produced by reduction and hydrogenation of a mixture of fatty acids derived from coconut oil. Various carbon chain lengths and distributions of various carbon chain lengths ranging from C5 to C14, including C8 to C10, C9 to C12 and C12 to C14, as well as mixtures of the foregoing, are commercially available from Biosynthis Ltd. (Saint-Cyr-sous-Dourdan France). Coconut alkanes are described in U.S. Pregrant Patent Application Publication Nos. 2012 / 0027702, 2017 / 0143610, 2018 / 0256479, 2019 / 0343753, 2019 / 0343753, and 2021 / 0154110, the disclosures of each of which are incorporated in their entirety in relevant part.

[0077] Coco-caprylate / caprate (CAS#95912-86-0) is a mixture of esters of coconut alcohol (a mixture of fatty alcohols derived from coconut oil) with caprylic and capric acids. Non-limiting examples of commercially available coco-caprylate / caprate include Cetiol® LC (BASF Corporation, Florham Park, NJ), Dub 810 C (Stearinerie Dubois Fils, Boulogne Billancourt, France), and Lanol™ 2681 (Seppic, Paris, France).

[0078] Mixtures of coconut alkanes and coco-caprylates / caprates are commercially available under the trade names Vegelight® 1214 (Biosynthis) and Vegesil™ 345 (Global Ingredient Solutions, Irvine, Calif.).

[0079] In some embodiments, the mixture of coconut alkane and coco-caprylate / caprate comprises about 99:1, about 95:5, about 90:10, about 85:15, about 80:20, about 75:25, about 70:30, about 65:35, about 60:40, about 55:45, about 50:50, about 45:55, about 40:60, about 35:65, about 30:70, about 25:75, about 20:80, about 15:85, about 10:90, about 5:95, about 1:99, or any ratio therebetween. In some embodiments, the composition of the present disclosure comprises a 90%:10% mixture of coconut alkane and coco-caprylate / caprate.

[0080] In some embodiments, the compositions of the present disclosure comprise about 30-70% by weight, e.g., 30%-67% by weight, 30%-65% by weight, 30%-60% by weight, 30%-55% by weight, 30%-50% by weight, 30%-45% by weight, 30%-40% by weight, 30%-35% by weight, 35%-70% by weight, 35%-67% by weight, 35%-65% by weight, 35%-60% by weight, 35%-55% by weight, 35%-50% by weight, 35%-45% by weight, 3 ... 40%-42%; 42%-43%; 43%-44%; 44%-45%; 45%-70%; 45%-67%; 45%-65%; 45%-60%; 45%-55%; 45%-50%; or 45%-50% by weight. In some embodiments, the compositions of the present disclosure comprise coconut alkanes in a concentration of about 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69% or 70% by weight based on the total weight of the formulation.

[0081] In some embodiments, the compositions of the present disclosure include coco-caprylate / caprate in a concentration range of 3-7% by weight, e.g., 3%-6.5% by weight, 3%-6% by weight, 3%-5.5% by weight, 3%-5% by weight, 3%-4.5% by weight, 3%-4% by weight, 3%-3.5% by weight, 3.5%-7% by weight, 4%-7% by weight, 4.5%-7% by weight, 5%-7% by weight, 5.5%-7% by weight, 6%-7% by weight, 6.5%-7% by weight, 4%-7% by weight, 4%-6.5% by weight, 4%-6% by weight, 4%-5.5% by weight, 4%-5% by weight, 4%-4.5% by weight, based on the total weight of the formulation. In some embodiments, the compositions of the present disclosure include coco-caprylate / caprate at a concentration of about 3%, 3.5%, 4%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5%, 5.5%, 6%, 6.5%, or 7% by weight based on the total weight of the formulation.

[0082] In some embodiments, the composition of the present disclosure comprises (i) about 30% to 70% by weight of coconut alkane, and (ii) about 3% to 7% by weight of coco-caprylate / caprate. In some embodiments, the composition of the present disclosure comprises (i) about 30% to 67% by weight of coconut alkane, and (ii) about 3% to 7% by weight of coco-caprylate / caprate. In some embodiments, the composition of the present disclosure comprises (i) about 30% to 65% by weight of coconut alkane, and (ii) about 3% to 7% by weight of coco-caprylate / caprate. In some embodiments, the composition of the present disclosure comprises about 42% to 43% by weight of coconut alkane and about 4% to 5% by weight of coco-caprylate / caprate. In some embodiments, the compositions of the present disclosure comprise about 46.8% of a mixture of coconut alkane and coco-caprylate / caprate, where the coconut alkane comprises about 90% of the mixture (42.12% of the composition weight) and the coco-caprylate / caprate comprises about 10% of the mixture (4.68% of the composition weight).

[0083] In some embodiments, the present disclosure is directed to a skin barrier protection delivery system comprising or consisting essentially of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of two or more of coconut alkane to coco-caprylate / caprate in a ratio of about 3:1 to about 9:1, and (b) petrolatum at a concentration of at least about 30%. In some embodiments, the petrolatum is present at a concentration of 40% by weight. In some embodiments, the petrolatum is present at a concentration of 50% by weight.

[0084] In certain embodiments, the skin barrier protection delivery system comprises or consists essentially of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of two or more of coconut alkane to coco-caprylate / caprate in a ratio of about 3:1 to about 9:1, and (b) petrolatum at a concentration of at least about 30%, the ratio of (a) to (b) being about 7:3 to about 1:3. In some embodiments, the petrolatum is present at a concentration of 40% by weight. In some embodiments, the petrolatum is present at a concentration of 50% by weight.

[0085] In some embodiments, the present disclosure is directed to a skin barrier protection delivery system comprising or consisting essentially of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of two or more of coconut alkane to coco-caprylate / caprate in a ratio of about 3:1 to about 9:1, and (b) petrolatum at a concentration of at least about 30%, wherein the ratio of (a) to (b) is about 7:3 to about 1:3, and the skin barrier protection delivery system is sprayable. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0086] In some embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of the two, to (b) petrolatum is about 7:3 to about 3:7. In some embodiments, petrolatum is present at a concentration of 25-60% by weight. In some embodiments, petrolatum is present at a concentration of 40% by weight.

[0087] In some embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of the two, to (b) petrolatum is about 2:1 to about 1:2. In other embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of the two, to (b) petrolatum is about 3:2 to about 2:3. In some embodiments, petrolatum is present at a concentration of 25-60% by weight. In some embodiments, petrolatum is present at a concentration of 40% by weight. In some embodiments, petrolatum is present at a concentration of 50% by weight.

[0088] In yet other embodiments of the skin barrier protection delivery system of the present disclosure, the ratio of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of the two, to (b) petrolatum is about 5:4 to about 4:5, in some embodiments about 10:9 to about 9:10, and about 1:1. In some embodiments, the ratio of (a) coconut alkane and / or coco-caprylate / caprate, optionally a mixture of the two, to (b) petrolatum is about 1:1. In some embodiments, the petrolatum is present in a concentration of 25-60% by weight. In some embodiments, the petrolatum is present in a concentration of 40% by weight. In some embodiments, the petrolatum is present in a concentration of 50% by weight.

[0089] In these embodiments, the ratio of (i) coconut alkane to (ii) coco-caprylate / caprate is from about 3:1 to about 9:1.

[0090] Other excipients In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises at least one of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols, and / or phospholipids. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least two of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols, and / or phospholipids. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least three of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols, and / or phospholipids. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least four of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols, and / or phospholipids. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols, and / or phospholipids.

[0091] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises a plant-based ester or wax. Vegetable oils, esters and waxes derived from plants, sterols, and phytosterols and esters of fatty acids (e.g., derived from plant seed oils) can be used in cosmetics, personal care products, and dermatological products.

[0092] In some embodiments, the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax and sunflower wax. In some embodiments, the plant-based ester or wax is or comprises jojoba esters. Simmondsia Chinensis (Jojoba) Seed Oil is a fixed oil expressed or extracted from the seeds of the desert shrub, jojoba, Simmondsia Chinensis.

[0093] Macadamia integrifolia seed oil is a fixed oil obtained from the nuts of Macadamia integrifolia.

[0094] Jojoba Oil / Macadamia Seed Oil Ester (CAS#97593-46-9) is a mixture of esters formed by the transesterification of jojoba seed oil and the seed oil of Macadamia integrifolia.

[0095] In certain embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one phytosterol and / or terpene (eg, squalene).

[0096] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises terpene. Terpene is an organic compound that consists of isoprene, a 5-carbon building block. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises triterpene (C30), hemiterpene (C5), monoterpene (C10), sesquiterpene (C15), diterpene (C20), sesterterpene (C25), tetraterpene (C40), or any mixture thereof.

[0097] In some embodiments, the terpene is a triterpene. In some embodiments, the triterpene is squalene. Squalene (CAS#111-02-4) is an unsaturated branched-chain isoprenoid (triterpene) hydrocarbon found in various vegetable oils or derived through fermentation.

[0098] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one phytosterol. Phytosterol (C 17 H 28 O, CAS#949109-75-5) is a family of gonan plant-derived alcohols, which are tetracyclic hydrocarbons with no double bonds. In some embodiments, the hydrogen atom at the 3-position of the gonan is replaced by a hydroxy group.

[0099] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises phytosterol esters. In some embodiments, the phytosterol esters comprise esters derived from plants, such as seed oils or nut oils. In some embodiments, the seed oils or nut oils are selected from the group consisting of macadamia oil, almond oil, avocado oil, canola oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine seed oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil, and walnut oil.

[0100] In some embodiments, the phytosterol ester is phytosteryl macadamiate. Phytosteryl macadamiate (CAS#68990-51-2) is an ester of phytosterol and fatty acids derived from the seed oil of Macadamia Integrifolia.

[0101] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises tocopherol. Vitamin E is a plant-derived fat-soluble substance composed of a chromanol ring with a side chain located at the C2 position. Tocopherol (CAS#10191-41-0) is a form of vitamin E designated alpha, beta, gamma, and delta based on the number and position of methyl groups on the chromanol ring. Any form of tocopherol can be used in the composition of the present disclosure.

[0102] Certain embodiments of the skin barrier protection delivery system of the present disclosure include at least one ceramide. Certain embodiments of the skin barrier protection delivery system of the present disclosure include at least two ceramides. In certain embodiments, the ceramide is one or both of ceramide AP and / or ceramide NP. Ceramides are a group of sphingolipids that contain derivatives of sphingosine bases amide-linked with various fatty acids. Along with other stratum corneum lipids, ceramides play an important role in building and maintaining the barrier function of the skin. In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide AP. In some embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide NP. Ceramide AP is an N-acylated sphingolipid consisting of phytosphingosine with a D-erythro structure linked to an alpha-hydroxy saturated or unsaturated fatty acid. Ceramide NP is an N-acylated sphingolipid consisting of phytosphingosine with a D-erythro structure linked to a normal saturated or unsaturated fatty acid.

[0103] Many dermatological conditions and disorders with reduced skin barrier function are characterized by reduced ceramide content.Topical formulations that deliver lipids identical to or mimic lipids in skin have been reported to improve skin condition.See, for example, Coderch, L., Lopez, O., de la Maza A., Parra J. "Ceramides and skin function" Am.J.Clin.Dermatol.2003;4(2):107-29.

[0104] In some embodiments, the skin barrier protection agent delivery system of the present disclosure comprises a triglyceride. In some embodiments, the triglyceride is a C18-C36 acid triglyceride. In some embodiments, the triglyceride is a C12-18 acid triglyceride.

[0105] In some embodiments, the skin barrier protection delivery system of the present disclosure includes a mixture of jojoba esters, squalene, phytosteryl macadamiate, phytosterols, tocopherols, C18-C36 triglycerides, and C12-C18 triglycerides in a combination wax under the trade name "L22®". Designed to mimic the distribution of skin lipids in "younger skin", L22® (Flora Technologies, Ltd., Chandler, AZ) is composed of jojoba oil / macadamia seed oil esters, squalene, phytosteryl macadamiate, phytosterols, and tocopherols. The main components of L22 are jojoba oil / macadamia seed oil esters (about 85%) and squalene (12.5%). Phytosteryl macadamiate and phytosterols are present in L22 at a combined concentration of about 2.5%.

[0106] In certain embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one ceramide, at least two ceramides, or at least one phytosterol and / or squalene.

[0107] In certain embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one ceramide, at least two ceramides, or at least one phytosterol and squalene.

[0108] In certain embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one ceramide, triglyceride, phytosterol, phytosterol macadamiate, squalene, jojoba esters, and tocopherol.

[0109] In certain embodiments, the skin barrier protection delivery system of the present disclosure includes ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglycerides, and C12-18 acid triglycerides. Each of the embodiments may optionally include one or a mixture of plant-derived esters.

[0110] In certain embodiments, the plant-derived esters include jojoba oil / macadamia seed oil esters and / or phytosteryl macadamiate. In certain embodiments, the skin barrier protection delivery system of the present disclosure includes jojoba oil / macadamia seed oil esters and phytosteryl macadamiate.

[0111] When present, the plant-based esters are included in the skin barrier protection delivery system of the present disclosure, alone or in combination with one or more plant oils or waxes, at combined concentrations of up to about 20% by weight, up to about 15% by weight, up to about 10% by weight, up to about 5% by weight, or up to about 1% by weight. For example, the plant-based esters may be present in an amount of about 0.1-0.15% by weight, about 0.15-0.2% by weight, about 0.2-0.25% by weight, about 0.25-0.3% by weight, about 0.3-0.35% by weight, about 0.35-0.4% by weight, about 0.4-0.45% by weight, about 0.45-0.5% by weight, about 0.5-0.55% by weight, about 0.55-0.6% by weight, about 0.6-0.65% by weight, about 0.65-0.7% by weight, about 0.7-0.8% by weight, about 0.8-0.9% by weight, about 0.9-0.1% by weight, about 0.9-0.1% by weight, about 0.9-0.2% by weight, about 0.9-0.2% by weight, about 0.9-0.3% by weight, about 0.9-0.4% by weight, about 0.9-0.5% by weight, about 0.9-0.5% by weight, about 0.9-0.5% by weight, about 0.9-0.6% by weight, about 0.9-0.7% by weight, about 0.9-0.8 ... It may be present in an amount of 0.75%, about 0.75-0.8%, about 0.8-0.85%, about 0.85-0.9%, about 0.9-0.95%, about 0.95-1%, about 1-1.5%, about 1.5-2%, about 2-3%, about 3-4%, about 4-5%, about 5-6%, about 6-7%, about 7-8%, about 8-9%, about 9-10%, about 10-15%, or about 15-20% by weight.

[0112] Terpenes (e.g., squalene), when present, are included in the skin barrier protection delivery system of the present disclosure at concentrations of up to 5% by weight, less than about 4% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight. For example, the terpene (e.g., squalene) may be present in an amount of about 0.1-0.15% by weight, about 0.15-0.2% by weight, about 0.2-0.25% by weight, about 0.25-0.3% by weight, about 0.3-0.35% by weight, about 0.35-0.4% by weight, about 0.4-0.45% by weight, about 0.45-0.5% by weight, about 0.5-0.55% by weight, about 0.55-0.6% by weight, based on the total weight of the formulation. %, about 0.6-0.65%, about 0.65-0.7%, about 0.7-0.75%, about 0.75-0.8%, about 0.8-0.85%, about 0.85-0.9%, about 0.9-0.95%, about 0.95-1%, about 1-1.5%, about 1.5-2%, about 2-3%, about 3-4%, or about 4-5% by weight. In some embodiments, squalene is present in an amount of about 0.37% based on the total weight of the formulation.

[0113] In one embodiment, at least one ceramide, when present, is included in the skin barrier protection delivery system of the present disclosure at a concentration ranging from about 0.01% to about 0.5%. For example, the ceramide may be present at a concentration of about 0.01% to about 0.1%, about 0.05% to 0.4% by weight, about 0.05% to 0.3% by weight, about 0.05% to 0.2% by weight, about 0.05% to 0.1% by weight, about 0.05% to 0.06% by weight, about 0.06% to 0.06% by weight, about 0.07% to 0.08% by weight, about 0.08% to 0.09% by weight, or about 0.09% to 0.1% by weight.

[0114] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises at least one of a polysaccharide, a gum, a buffering agent (eg, an acid), and a root plant extract.

[0115] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one polysaccharide.In some embodiments, the at least one polysaccharide can be, for example, maltodextrin, cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid, and mixtures thereof.In some embodiments, the polysaccharide is maltodextrin.

[0116] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one gum. In some embodiments, the at least one gum may be selected from the group consisting of, for example, guar gum, xanthan gum, pullulan gum, agar-agar gum, carrageenan gum, gellan gum, gum arabic, and gum tragacanth. In some embodiments, the gum is gum arabic (Acacia Senegal).

[0117] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one plant extract. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one root plant extract. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one fruit extract. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one vegetable extract. In some embodiments, the at least one root plant extract is selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish, and radish. In some embodiments, the root plant extract is sweet potato (Ipomoea Batatas) root extract. In some embodiments, the at least one plant extract is derived from cucumber, garlic, pepper, berries (including raspberries, blackberries, strawberries, elderberries, blueberries, bilberries), asparagus, and the like. In some embodiments, the plant extract is (Vaccinium Myrtillus) fruit extract. In some embodiments, the plant extract is cucumber (Cucumis Sativus) fruit extract. In some embodiments, the plant extract is an extract of garlic (Allium Sativum). The plant extract may be present in the composition of the present disclosure in the range of 0.01-0.1% by weight. In some embodiments, the plant extract is present in the composition of the present disclosure in the range of about 0.01-0.9% by weight, about 0.01-0.85% by weight, about 0.01-0.8% by weight, about 0.01-0.75% by weight, about 0.01-0.7% by weight, about 0.01-0.65% by weight, about 0.01-0.6% by weight, about 0.01-0.55% by weight, about 0.01-0.5% by weight, about 0.01-0.45% by weight, about 0.01-0.4% by weight, about 0.01-0.35% by weight, about 0.01-0.5% by weight, about 0.01-0.6% by weight, about 0.01-0.7% by weight, about 0.01-0.8% by weight, about 0.01-0.9% by weight, about 0.01-0.85% by weight, about 0.01-0.8% by weight, about 0.01-0.75% by weight, about 0.01-0.7% by weight, about 0.01-0.65% by weight, about 0.01-0.6% by weight, about 0.01-0.55% by weight, about 0.01-0.5% by weight, about 0.01-0.45% by weight, about 0.01-0.4% by weight, about 0.01-0.35% by weight, about 0.01-0.5% by weight, about 0.01-0.5% by weight, about 0.01-0. The compound is present in a concentration range of about 0.3% by weight, about 0.01-0.25% by weight, about 0.01-0.2% by weight, about 0.01-0.15% by weight, about 0.01-0.1% by weight, about 0.01-0.02% by weight, about 0.02-0.03% by weight, about 0.03-0.04% by weight, about 0.04-0.05% by weight, about 0.0-0.06% by weight, about 0.06-0.07% by weight, about 0.07-0.08% by weight, about 0.08-0.09% by weight, or about 0.09-0.1% by weight.

[0118] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one buffering agent. In some embodiments, the buffering agent is an acid. In some embodiments, the acid is citric acid. In other embodiments, the acid may be a carboxylic acid. In some embodiments, the acid is selected from the group consisting of citric acid, acetic acid, succinic acid, lactic acid, maleic acid, fumaric acid, palmitic acid, cholic acid, pamoic acid, mucic acid, D-glutamic acid, D-camphoric acid, glutaric acid, phthalic acid, tartaric acid, lauric acid, stearic acid, salicylic acid, sorbic acid, benzoic acid, and cinnamic acid, and salts thereof, such as their alkali metal salts or alkaline earth metal salts. In some embodiments, the acid is citric acid / sodium citrate. In some embodiments, the buffering agent is about 0.001 to 1 wt%, about 0.001 to 0.5 wt%, about 0.001 to 0.1 wt%, about 0.001 to 0.05 wt%, about 0.001 to 0.01 wt%, about 0.001 to 0.005 wt%, about 0.001 to 0.003 wt%, about 0.001 to 0.002 wt%, based on the total weight of the formulation. Amount%, about 0.01-5% by weight, about 0.01-1% by weight, about 0.1-1% by weight, about 0.5-1% by weight, about 0.01-0.05% by weight, about 0.05-0.1% by weight, Approximately 0.1~0.15% by weight, approximately 0.15~0.2% by weight, approximately 0.2~0.25% by weight, approximately 0.25~0.3% by weight, approximately 0.3~0.35% by weight, approximately 0.35~0 0.4 wt% or about 0.4-0.45 wt%, about 0.45-0.5 wt%, about 0.5-0.55 wt%, about 0.55-0.6 wt%, about 0.6-0.65 wt%, about 0.65-0.7 wt%, about 0.7-0.75 wt%, about 0.75-0.8 wt%, about 0.8-0.85 wt%, about 0.85-0.9 wt%, about 0.9-0. It is present in a concentration of about 0.95% by weight, about 0.95-1% by weight, about 1-1.5% by weight, about 1.5-2% by weight, about 2-3% by weight, about 3-4% by weight, about 4-5% by weight, about 5-6% by weight, about 6-7% by weight, about 7-8% by weight, about 8-9% by weight, about 9-10% by weight, about 10-15% by weight, about 15-20% by weight, or about 20-30% by weight.

[0119] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises at least one of Ipomoea Batatas root extract, citric acid, gum arabic (Acacia Senegal), and maltodextrin. In some embodiments, the skin barrier protection delivery system of the present disclosure comprises Ipomoea Batatas root extract, citric acid, gum arabic (Acacia Senegal), and maltodextrin. A combination of Ipomoea Batatas root extract, citric acid, gum arabic (Acacia Senegal), and maltodextrin is commercially available under the trade name Natpure Xfine Potato SP313.

[0120] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato (Ipomoea Batatas) root extract, gum arabic (Acacia Senegal), citric acid, and maltodextrin.

[0121] In some embodiments, the skin barrier protection delivery system of the present disclosure further comprises zinc oxide. In some embodiments, the zinc oxide is present in a concentration range of about 1-23% by weight, e.g., about 5-15%, about 8-10%, about 10-12%, about 12-14%, about 10-15%, about 15-20%, about 20-25%, or about 25-30% by weight. In some embodiments, the zinc oxide is present in a concentration of about 10%, about 10.5%, about 11%, about 11.5%, about 12%, about 12.5%, about 13%, about 13.5%, about 14%, about 14.5%, or about 15% by weight.

[0122] The excipients in the skin barrier protection delivery system of the present disclosure may be, individually or cumulatively, from about 0.001 to 10% by weight, from about 0.001 to 5% by weight, from about 0.001 to 1% by weight, from about 0.001 to 0.5% by weight, from about 0.001 to 0.4% by weight, from about 0.001 to 0.3% by weight, from about 0.001 to 0.25% by weight, from about 0.001 to 0.2% by weight, from about 0.001 to 0.15% by weight, from about 0.001 to 0.2% by weight, from about 0.001 to 0.3% by weight, from about 0.001 to 0.4% by weight, from about 0.001 to 0.5% by weight, from about 0.001 to 0.6% by weight, from about 0.001 to 0.8% by weight, from about 0.001 to 0.9% by weight, from about 0.001 to 0.1% by weight, from about 0.001 to 0.2% by weight, from about 0.001 to 0.3% by weight, from about 0.001 to 0.4% by weight, from about 0.001 to 0.5% by weight, from about 0.001 to 0.6% by weight, from about 0.001 to 0.7% by weight, from about 0.001 to 0.8% by weight, from about 0.001 to 0.9% by weight, from about 0.001 to 0.1% by weight, from about 0.001 to 0.2% by weight, from about 0.001 to 0.3% by weight, from about 0.001 to 0.4% by .1% by weight, approximately 0.001~0.05% by weight, approximately 0.001~0.04% by weight, approximately 0.001~0.03% by weight, approximately 0.001~0.01% by weight, approximately 0.001~0.025% by weight, approximately 0.00 1~0.02% by weight, approximately 0.001~0.015% by weight, approximately 0.005~0.01% by weight, approximately 0.01~0.05% by weight, approximately 0.05~0.1% by weight, approximately 0.1~0.15% by weight, approximately 0.15~0 0.2% by weight, about 0.2-0.25% by weight, about 0.25-0.3% by weight, about 0.3-0.35% by weight, about 0.35-0.4% by weight, or about 0.4-0.45% by weight to about 0.45-0.5% by weight, about 0.5-0.55% by weight, about 0.55-0.6% by weight, about 0.6-0.65% by weight, about 0.65-0.7% by weight, about 0.7-0.75% by weight, about 0.75-0.8% by weight, about 0.8-0.85% by weight %, about 0.85-0.9 weight%, about 0.9-0.95 weight%, about 0.95-1 weight%, about 1-1.5 weight%, about 1.5-2 weight%, about 2-3 weight%, about 3-4 weight%, about 4-5 weight%, about 5-6 weight%, about 6-7 weight%, about 7-8 weight%, about 8-9 weight%, about 9-10 weight%, about 10-15 weight%, about 15-20 weight%, or about 20-30 weight%.

[0123] Exemplary Compositions In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30% by weight petrolatum, (ii) coconut alkane in the range of 30-70% by weight; (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NP in the range of 0.01-0.1% by weight; (v) ceramide AP in the range of 0.01-0.1% by weight; (vi) jojoba esters in the range of 0.1-1.5% by weight; (vii) glyceryl esters in the range of 0.1-1% by weight. (viii) squalene in the range of 0.01 to 0.1% by weight; (ix) phytosterols in the range of 0.005 to 0.1% by weight; (x) tocopherols in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5 to 5% by weight; (xii) C12-18 acid triglycerides in the range of 0.1 to 1% by weight; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) maltodextrin in the range of 0.001 to 0.1% by weight. In some embodiments, the delivery system is a sprayable formulation.

[0124] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) at least 30% by weight petrolatum, (ii) coconut alkane in the range of 30-67% by weight, (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NP in the range of 0.01-0.1% by weight; (v) ceramide AP in the range of 0.01-0.1% by weight; (vi) jojoba esters in the range of 0.1-1.5% by weight; (vii) glyceryl esters in the range of 0.1-1% by weight. (viii) squalene in the range of 0.01 to 0.1% by weight; (ix) phytosterols in the range of 0.005 to 0.1% by weight; (x) tocopherols in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5 to 5% by weight; (xii) C12-18 acid triglycerides in the range of 0.1 to 1% by weight; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) maltodextrin in the range of 0.001 to 0.1% by weight. In some embodiments, the delivery system is a sprayable formulation.

[0125] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) at least 30% by weight petrolatum; (ii) coconut alkane in the range of 30-65% by weight; (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NP in the range of 0.01-0.1% by weight; (v) ceramide AP in the range of 0.01-0.1% by weight; (vi) jojoba esters in the range of 0.1-1.5% by weight; (vii) jojoba esters in the range of 0.1-1% by weight. (viii) squalene in the range of 0.01 to 0.1% by weight; (ix) phytosterols in the range of 0.005 to 0.1% by weight; (x) tocopherols in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5 to 5% by weight; (xii) C12-18 acid triglycerides in the range of 0.1 to 1% by weight; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) maltodextrin in the range of 0.001 to 0.1% by weight. In some embodiments, the delivery system is a sprayable formulation.

[0126] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) 50% by weight petrolatum; (ii) 42-43% by weight coconut alkane; (iii) 4-5% by weight coco-caprylate / caprate; (iv) 0.05% by weight ceramide NP; (v) 0.05% by weight ceramide AP; (vi) 0.75% by weight jojoba esters; (vii) 0.3-0.4% by weight squalene; (viii) 0.05-0.06% by weight of phytosteryl macadamiate; (ix) 0.01-0.02% by weight of phytosterol; (x) 0.0045% by weight of tocopherol; (xi) 1-2% by weight of C18-36 acid triglyceride; (xii) 0.4-0.5% by weight of C12-18 acid triglyceride; (xiii) 0.03-0.04% by weight of sweet potato (ipomoea batatas) root extract; (xiv) 0.003-0.004% by weight of citric acid; (xv) 0.03-0.04% by weight of gum arabic (Acacia Senegal); and (xvi) 0.03-0.04% by weight of maltodextrin.

[0127] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises: (i) 25-60% by weight petrolatum; (ii) 10-25% by weight zinc oxide (ZnO); and (iii) 30-60% by weight isohexadecane.

[0128] In some embodiments, the skin barrier protection delivery system of the present disclosure comprises (i) 40% by weight petrolatum, (ii) 15% by weight zinc oxide (ZnO), and (iii) 45% by weight isohexadecane.

[0129] In some embodiments, other long chain alkanes can be used in place of coconut alkanes to dissolve petrolatum. In some embodiments, the long chain alkanes can have more than 10 carbons, for example, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 carbons, or even greater carbon lengths. In some embodiments, the long chain alkanes contain 10-40 carbon atoms, for example, 10-25, 10-20, 10-15, 20-30, 25-30, 30-35, 35-40, etc.

[0130] In some embodiments, esters of long chain alcohols and carboxylic acids (e.g., fatty acids) can be used in place of coco-caprylate / caprate to dissolve petrolatum. For example, the esters can include long chain alcohols having more than 10 carbons, such as 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, or 40 carbons, or even greater carbon lengths. In some embodiments, the long chain alcohols include 10-40 carbon atoms, such as 10-25, 10-20, 10-15, 20-30, 25-30, 30-35, 35-40, etc. The carboxylic acids can include from about 10 to about 30 carbon atoms. Suitable carboxylic acids are fatty acids, including saturated and unsaturated fatty acids.Non-limiting examples of fatty acids include oleic acid, linoleic acid, palmitic acid, stearic acid, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA).Unsaturated 18-carbon fatty acids with double bonds at C9-C10 (oleic acid), C9-C10 and C12-C13 (linoleic acid), and C9-C10, C12-C13, and C15-C16 (linolenic acid) can also be used.

[0131] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising: (i) a mixture of long chain alkanes having a carbon length greater than 10 carbons in a concentration range of 30-70% by weight; and (ii) petrolatum present in a concentration of at least 30% by weight, wherein the delivery system is sprayable.

[0132] In some embodiments, the present disclosure provides a skin barrier protection delivery system comprising: (i) a mixture of a long chain alkane having a carbon length greater than 10 carbons in a concentration range of 30-70% by weight and an ester of a long chain alcohol in a concentration of 3-7% by weight; and (ii) petrolatum, wherein the petrolatum is present in a concentration of at least 30% by weight, and wherein the delivery system is sprayable.

[0133] Active ingredient A variety of functional ingredients, including natural ingredients, including plant and algae derived ingredients, as well as active pharmaceutical ingredients, can be incorporated into the skin barrier protection delivery system of the present disclosure.

[0134] The "active ingredients" may be incorporated (i.e., included) in the skin barrier protection delivery system of the present disclosure at a concentration ranging from about 0.001% to about 20% by weight, about 0.005% to about 10% by weight, about 0.01% to about 5% by weight, or about 0.1% to about 2.0% by weight, and include agents for the treatment of inflammatory skin diseases, both steroidal and non-steroidal (including, but not limited to, acne, eczema, psoriasis, rosacea, and radiation exposure), antimicrobial and antifungal actives, antipruritic agents, local anesthetics, sunscreens, emollients and skin soothing agents, moisturizers and humectants including hyaluronic acid, skin barrier protectors (USFDA OTC Final Active pharmaceutical ingredients (over the counter or prescription) that prevent or treat (or help prevent or treat) a pathophysiological condition (e.g., disease) including, but not limited to, ulcerated skin, lipids including vegetable derived oils and butters, vitamins, proteins and peptides, antioxidants and agents that reduce the appearance of fine lines and wrinkles, skin lightening agents, agents that contribute to wound healing / wound cosmetology, agents that reduce inflammation (including erythema) and / or edema,

[0135] One non-limiting "active" ingredient included in the skin barrier protection delivery system of the present disclosure is Ipomoea Batatas Root Extract, which has been shown to reduce limb swelling when applied in accordance with the present disclosure. Ipomoea Batatas Root Extract may be present in the compositions of the present disclosure in the range of 0.01-0.1% by weight. In some embodiments, Ipomoea Batatas Root Extract is present in the compositions of the present disclosure in the range of 0.01-0.1% by weight. In some embodiments, Ipomoea Batatas Root Extract is present in the compositions of the present disclosure in the range of 0.01-0.1% by weight. batatas) root extract is present in an amount of about 0.01-0.9% by weight, about 0.01-0.85% by weight, about 0.01-0.8% by weight, about 0.01-0.75% by weight, about 0.01-0.7% by weight, about 0.01-0.65% by weight, about 0.01-0.6% by weight, about 0.01-0.55% by weight, about 0.01-0.5% by weight, about 0.01-0.45% by weight, about 0.01-0.4% by weight, about 0.01-0.35% by weight, about 0.01-0.3% by weight, about 0.01-0.4% by weight, about 0.01-0.5% by weight, about 0.01-0.6% by weight, about 0.01-0.7% by weight, about 0.01-0.8% by weight, about 0.01-0.8% by weight, about 0.01-0.9% by weight, about 0.01-0.85% by weight, about 0.01-0.8% by weight, about 0.01-0.75% by weight, about 0.01-0.7% by weight, about 0.01-0.65% by weight, about 0.01-0.6% by weight, about 0.01-0.55% by weight, about 0.01-0.5% by weight, about 0.01-0.45% by weight, about 0.01-0.4% by weight, about 0.01-0.35% by weight, about 0.01-0.3% by weight, about 0.01-0.4% by weight, about 0.01-0.5% by weight, about 0.01-0.5 %, about 0.01-0.25 wt%, about 0.01-0.2 wt%, about 0.01-0.15 wt%, about 0.01-0.1 wt%, about 0.01-0.02 wt%, about 0.02-0.03 wt%, about 0.03-0.04 wt%, about 0.04-0.05 wt%, about 0.05-0.06 wt%, about 0.06-0.07 wt%, about 0.07-0.08 wt%, about 0.08-0.09 wt%, or about 0.09-0.1 wt%. In some embodiments, the skin barrier protection delivery system of the present disclosure is applied by spraying or misting. In one embodiment, the skin barrier protection delivery system of the present disclosure has a viscosity (TE@10) of about 500 cps to 10,000 cps. In one embodiment, the skin barrier protection delivery system of the present disclosure has a viscosity (TE@10) of about 1,000 cps to 5000 cps.

[0136] In some embodiments, it has been unexpectedly discovered that the skin barrier protection delivery system of the present disclosure can be formulated as a gel with sprayable properties. In some embodiments, the skin barrier protection delivery system of the present disclosure can be formulated as a liquid or gel-like composition with sprayable properties. It has been discovered that a petrolatum-containing composition results in a gel-like mixture that can be sprayed, for example, through an atomizer (a fine spray typically used to create a fine mist of perfume). In some embodiments, no pressure (i.e., aerosol or bag-on-valve) is required to spray the gel.

[0137] In some embodiments, the present disclosure provides a pharmaceutical composition in the form of a sprayable gel comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the composition does not include a propellant, aerosol or bag-on-valve.

[0138] In some embodiments, the compositions of the present disclosure do not contain flammable components. In some embodiments, the compositions of the present disclosure do not include flammable solubilizers. In some embodiments, the compositions of the present disclosure do not include alcohol.

[0139] In some embodiments, the present disclosure provides a device comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the present disclosure provides a device comprising a pharmaceutical composition, the pharmaceutical composition comprising the skin barrier protection delivery system of the present disclosure. In some embodiments, the device does not include a propellant. In some embodiments, the device does not include an aerosol. In some embodiments, the device does not include a bag-on-valve. In some embodiments, the device is in the form of a sprayer pump. In some embodiments, the device is a dip tube sprayer pump.

[0140] Devices that can be used for spraying or atomization include pump sprays, trigger sprays, atomizers, aerosol containers (pressurized with propellants, such as non-fluorocarbon propellants, including bag-on-valve dispensers). In some embodiments, the spray composition of the present disclosure can be applied directly to the skin of a subject using a device. The device can be, for example, a metered-dose spray pump, such as a single-, double-dose, or multi-use spray device. In some embodiments, the device does not contain a propellant.

[0141] The numbers used in describing amounts of ingredients should be understood in all instances to be modified by the term "about."

[0142] Unless otherwise indicated, percentages should be understood as being based on the total weight of the skin barrier protection delivery system.

[0143] Numeric ranges are meant to include the numbers within the recited ranges, as well as combinations of subranges between the given ranges, for example, the range 1 to 5 includes 1, 2, 3, 4, and 5, as well as subranges 2 to 5, 3 to 5, 2 to 3, 2 to 4, 1 to 4, etc.

[0144] "At least one" means one or more and is inclusive of individual components and mixtures / combinations.

[0145] The disclosed compositions can also serve as a vehicle for the delivery of other therapeutic agents, and when so used, enhance the clinical response to such agents.

[0146] Examples of these other therapeutic agents are: (1) Anti-inflammatory agents, examples of which are corticosteroids, colchicine, sulfasalazine, and sulfones; (2) Antibiotics, examples of which are quinolones, macrolides, penicillins, cephalosporins, sulfonamides, and tetracyclines; (3) Antiviral agents, examples of which are acyclovir, idoxuridine, zidovudine, ddI, vidarabine, and trifluridine; (4) Antifungal drugs, examples of which are ketoconazole, econazole, griseofulvin, cicloprix, and nafatidine; (5) Antihistamines, examples of which are diphenhydramine, astemizole, hydroxyzine, doxepin, amitriptyline, cyproheptadine, and cromolyn sodium. (6) Antipruritic drugs, examples of which are camphor, menthol, phenol, benzocaine, benzyl alcohol, salicylic acid, dyclonine, and pramoxine. (7) Antitumor agents, examples of which are methotrexate, piritrexim, cisplatin, 5-fluorouracil, bleomycin, carmustine, hydroxyurea, azathioprine, and nitrogen mustard. (8) Carboxylic acid analogues, examples of which are 1-monolauric acid, azelaic acid and dodecanedioic acid. (9) Natural and synthetic vitamins and analogues, examples of which are vitamin D, calcipitriol, 1,25-dihydroxycholecalciferol, retinol, retinyl palmitate, retinyl ascorbate, isotretinoin, etretinate and retinoic acid, and (10) Artemisinin analogues, examples of which are artesunate, arteether, artemether, dihydroartemisinin and artelenic acid.

[0147] The concentrations of these therapeutic components may vary. A typical range is from about 0.01% to about 10%. The most appropriate concentration will depend on the clinical indication and will be apparent to one of skill in the art.

[0148] 6. Pharmaceutical Preparations Other cosmetic and / or pharmaceutical agents or excipients may be provided in the formulations of the present disclosure so long as they are non-toxic, physiologically acceptable and suitable for use in combination with the therapeutically effective amount of the active ingredient provided in the formulation.

[0149] For example, the claimed formulations of the present disclosure may include chemically compatible pharma- ceutically acceptable vehicles and excipients, such as water and / or alcohol.The formulations may also include emollients, such as petrolatum, zinc oxide, paraffin, mineral oil, glycerin, beeswax, olive oil, coconut oil, jojoba oil, lanolin, cocoa butter, butyl stearate, stearic acid, diglycol laurate, 2-ethylhexanol, almond butter, aloe vera gel, batana oil, caprylic / capric triglyceride, caprylyl-caprylate / caprate, cetyl palmitate, chia seed oil, coco-caprylate, collodion, doopa butter, dicaprylyl carbonate, dihydroxyacetone, dimethicone, myristate, shea butter, vegetable oils, fatty acids, fatty alcohols, triglycerides, benzoates, palmitates, squalene, and ceramides, derivatives, combinations, and mixtures thereof. The compositions may include skin conditioning agents such as butyl alcohol, cholesterol, lanolin, fatty acid esters, fatty acid ethers, cetyl acetate, silicones, vegetable oils, panthenol, panthenol triacetate, vitamin B, vitamin C, vitamin D, vitamin E, vitamin D, keratin, lysine, arginine, hydrolyzed wheat protein, hydrolyzed silk protein, colloidal oatmeal, zinc, coal tar, hydrocortisone, sulfides, emollients, derivatives, combinations and mixtures thereof.

[0150] The formulations may include pH adjusters such as alpha hydroxy acids, butylated hydroxy toluene (BHT), ethylenediaminetetraacetic acid (EDTA), triethanolamine (TEA), cosmetic salts, glycerin, propylene glycol, and derivatives, combinations and mixtures thereof.

[0151] Other acceptable ingredients include glycerin, propylene glycol, sorbitol, hexylene glycol, butylene glycol, urea, alpha-hydroxy acids, polyhydric alcohols, sorbitol, hydroxypropyl sorbitol, hexylene glycol, 1-3 dibutylene glycol, 1,2,6-hexanetriol, ethoxylated glycerol, propoxylated glycerol, and derivatives thereof, combinations and mixtures thereof may be incorporated herein. Pharmaceutically acceptable buffers, such as citric acid, sodium citrate, derivatives thereof, combinations and mixtures thereof are also useful and beneficial.

[0152] Other components that may be included are viscosity modifiers, such as salts, carbomer gelling agents, gum derivatives, and derivatives, combinations, and mixtures thereof. Preservatives, such as methylparaben, ethylparaben, butylparaben, formaldehyde, DMDM ​​hydantoin, leucidal liquid, propylparaben, phenoxyethanol, and derivatives, combinations, and mixtures thereof, are also useful in small amounts. The formulations of the present invention may include emulsifiers, such as polysorbate 80, glyceryl distearate, POE(2) stearyl ether, POE 10 stearyl ether, ceteareth 20, stearyl alcohol, ceteareth 20, cetearyl alcohol, lecithin, and derivatives, combinations, and mixtures thereof. For example, the formulations of the present invention may include chelating agents, such as ethylenediaminetetraacetic acid (EDTA), dihydroxyethylglycine, tartaric acid, and derivatives, combinations, and mixtures thereof. These formulations may also contain thickening agents such as salt, silica, bentonite, magnesium aluminum silicate, carbomer, gum, xanthan gum, gelatin, cetyl alcohol, stearyl alcohol, carnauba wax, stearic acid, polyacrylamide, C13-C14 isoparaffin, laureth-, and derivatives, combinations and mixtures thereof.

[0153] Additional optional elements of the formulations of the present disclosure include antioxidants such as green tea extract, ascorbyl palmitate, tocopheryl acetate, BHT, BHA, alpha lipoic acid, beta-glucan, coenzyme Q10, grape seed extract, green tea, soy sterols, superoxide dismutase, vitamin C (ascorbyl palmitate and magnesium ascorbyl palmitate), and vitamin E (alpha tocopherol, tocotrienols, tocopheryl acetate), pomegranate, turmeric, butylated hydroanisole (BHA), phenyl-naphthylamine, hydroquinone, propyl gallate, melatonin, nordihydroquaretic acid, and derivatives, combinations, and mixtures thereof.

[0154] The formulations of the present disclosure may also include anti-aging agents, such as agents for treating or preventing the development of wrinkles. Anti-aging, anti-wrinkle, anti-skin atrophy and skin repair actives may be effective in replenishing or rejuvenating the epidermal layer. These ingredients generally provide the desired skin care benefits by promoting or maintaining the natural process of desquamation. Examples of anti-wrinkle and anti-skin atrophy actives include alpha-lipoic acid, lycopene, ergothioneine, resveratrol, grape seed extract, cis-urocanic acid (see U.S. Pat. No. 5,620,680), compositions containing farnesol and / or bisabolol (see PCT Publication No. WO00 / 62744), 2-amino-1,3-octadecanediol, 2-N-acetylamino-1,3-octadecanediol, 2-N-octanoylamino-1,3-octadecanediol, 2-N-(2-hydroxyhexadecanol), 2-N-acetylamino-1,3-octadecanediol, 2-N-octanoylamino-1,3-octadecanediol, 2-N-hydroxyhexadecan ... Examples of 2-amino-1,3,4-octadecanediols include, but are not limited to, 2-N-(2-hydroxydocosanoyl)amino-1,3-octadecanediol, 2-N-(2-hydroxyhexadecanoyl)amino-1,3,4-octadecanediol, 2-N-hexanoylamino-1,3-octadecanediol, and 2-N-octanoylamino-1,3,4-octadecanediol (see U.S. Patent Application Publication No. 2002 / 0006420 to Philippe et al.).3-alkanediols, ubiquinones and plastoquinones (coenzymes Qn), in particular those selected from the list of coenzymes. Formulations containing one or more compounds selected from the group consisting of Q9 and Q10, prasterone, DHEA, dehydroepiandrosterone, sterols (e.g., cholesterol, dihydrocholesterol, 7-dehydrocholesterol, lanosterol, dihydrolanosterol, zosterols including spongosterol and stelasterol, phytonsterols including ergosterol, sitosterol, stigmasterol, fucosterol, brassicasterol and campesterol, mycosterols including ergosterol, fungisterol and zymosterol) and their biochemical precursors (e.g., mevalonic acid, famezole and squalane, etc.) in combination with one or more compounds including ubiquinone and its derivatives and plastoquinone and its derivatives (see U.S. Pat. No. 6,261,575), bertholletia extract, betulinic acid, biotin, blackberry bark extract, blackberry lee extract, black cohosh extract, blue cohosh extract, butanoyl betulinic acid, carboxymethyl 1,3 Beta-glucan, chalcone, chast tree extract, clover extract, coumestrol, daidzein, dang gui extract, daltoside, debromolyldiol, 1-decanoyl-glycero-phosphonic acid, dehydrodichloride, dehydrodiogenol, dehydroepiandrosterone, dehydroepiandrosterone sulfate, dianethol, diosgenin, dodecanedioic acid, ergosterol, fennel extract, fenugreek seed extract, formononetin, forsythia fruit extract, genistein, genisteinic acid, gentisyl alcohol, ginkgo biloba extract, ginseng extract, ginsenoside, 25-hydroxycholesterol, 7-hydroxylated sterol, hydroxyethyl isostearyloxyisopropanolamine, hydroxytetramethylpiperidinyloxy, hypotaurine, ibuki jaco extract, isoflavone, isoflavone SG 10 (Barnet (available from Maruzen), kinetin, coix seed extract, lectin, licochalcone LF15 (available from Maruzen), licorice extract, lignans, isterol, rumen, luteolin, lupeolin, lysophosphidic acid, naringenin, neotigogenin, o-desmethylangioiensin, oat beta-glucan, oleanolic acid, placenta extract, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, soybean extract, spleen extract, tachysterol, tigogenin, vitex extract, yam extract, yamogenin, zeatin, hyaluronic acid.

[0155] The formulations of the present disclosure may also contain other compounds such as phenoxyethanol, phenoxypropanol, phenoxyisopropanol, ethyl acetate, flavonoids and bioflavonoids; bile salts, such as simunol sulfate and its derivatives, deoxycholate, and cholate; allantoin; aloe extract; barberry extract; bearberry extract; belamcanda chinensis; berberine; BIODERMINE (available from Sederma); bioflavinoids; bisabolol; carrot extract; cassin oil; clove extract; citral; citronellal; cucumber extract; ethylhexyl monoglyceryl ether; ethyl 2-hydroxyundecanoate; farnesol; farnesol acetate; geranoyl; glabridin; glyceryl monocaprate; grapefruit seed extract; gugulipids; hesperitin; hinokitol; hops extract; hydrogenated rosin; lemongrass oil; linoleic acid; LIPACIDE C8CO (available from Seppic);Sapindus mukorossi;Neem seed oil;Panthenol;1-Pentadecanol;Penia extract;Peppermint extract;Phenola phellodendron extract;Phloretin;PHLOROGINE (available from Secma);Quercetin;Red sandalwood extract;Rosemary extract;Rutin;Sage extract;Skullcap extract;Siberian saxifrage extract;Sophora extract (available from Maruzen);sunder vati extract;Tea tree oil;Thyme extract;Trehalose 6-undecylenoate;3-Tridecen-2-ol;Triclosan;White thyme oil;Willow bark extract;Wogonin;Ylang-ylang;Zinc glycerolate;Zinc linoleate;Zinc oxide;Zinc pyrithione;Zinc sulfate;Urea;Triclosan, Phenoxyethanol and Phenoxypropanol, Ethyl acetate, Chlorhexidine and its derivatives, such as Chlorhexidine gluconate;Sebostats, such as flavinoids, prasterone, and antiseptic and disinfectant type antimicrobial agents, such as chloroxylenol, octowynol, and nonoxynol (Martindale The Extra Pharmacopoeia 29; th The anti-acne agents may include anti-acne agents selected from one or more of the list consisting of: urea, allantoin, povidone-iodine and phenol.

[0156] The lip balm composition contains behenic acid or acexamic acid, as well as chloroxylenol, octowynol and nonoxynol (Martindale The Extra Pharmacopoeia 29 th Edition), urea, allantoin, povidone-iodine and phenol, menthol, camphor, triclosan, phenoxyethanol, phenoxypropanol, ethyl acetate, chlorhexidine and its derivatives such as chlorhexidine gluconate, and antiseptic-type antimicrobial and antiseptic-type antibacterial agents.

[0157] Formulations of the present disclosure may also include skin conditioning agents, such as agents that smooth or soften the skin, selected from one or more of the list consisting of Aloe vera extract, Biocare SA (available from Amerchol); egg white; Flexan 130 (available from National Starch); Gatuline Lifting (available from Gattefosse); Pentacare HP (available from Pentapharm); Vegetable Seryl (available from Laboratories Serobioloques), Candelilla wax, alpha bisabolol, Aloe vera, Manjistha (extracted from plants of the genus Rubia, particularly Rubia Cordifolia), and Guggal (extracted from plants of the genus Commiphora, particularly Commiphora Mukul).

[0158] Formulations of the present disclosure may also include skin barrier repair ingredients that can help repair and replenish the natural moisture barrier function of the epidermis. Non-limiting examples of skin barrier repair actives include Alpha Lipid (available from Lucas Meyer); biotin; biotin esters; brassicasterol; caffeine; campesterol; canola-derived sterols; Cennamide (available from Ennagram); Ceramax (available from Alban Muller); CERAMAX (available from Quest, located in Ashford, England); CERAMIDE 2 and CERAMIDE HO3™ (both available from Sederma); CERAMIDE II (available from Quest); CERAMIDE Ill and IIIB (both available from Cosmoferm, located in Deft, Netherlands); CERAMIDE LS 3773 (available from Laboratories Serobiologiques); CERAMINOL (available from Inocosm); Cerasol and Cephalip (both available from Pentapharm); cholesterol; cholesterol hydroxystearate; cholesterol isostearate; 7 dehydrocholesterol; DERMATEIN BRC and DERMATEIN GSL (both available from Hormel); ELDEW CL 301 and ELDEW PS 203 (both available from Ajinomoto); Fitobroside (available from Pentapharm); Galactocerebroside; Generol, 122 (available from Henkel); Glyceryl serinamide; Hydroxyethyl isostearyl isopropanolamine; Lanolin; Lanolin alcohol; Lanosterol; Lauryl glucamide-N; Lipoic acid; N-Acetyl cysteine; N-Acetyl-L-serine; N-Methyl-L-serine; Net Sterol-ISO (available from Barnet Products); Palmitic acid; Panthenol; Pantethin; Phytosphingosine (Gist Brocades (King of Prussia, Pa.available from Brooks Industries, South Plainfield, NJ); PSENDOFILAGGRIN (available from Brooks Industries, South Plainfield, NJ); QUESTAMIDE H (available from Quest); Serine; Sigmasterol; Sitosterol; Soy-derived sterols; Sphingosine; Sphingomynase; S-Lactoyl Glutathione; Stearic acid; Structurine (available from Silah); SUPER STEROL ESTERS (available from Croda); Thioctic acid; THSC CERAMIDE OIL (available from Campo Research); Trimethylglycine; Tocopheryl nicotinate; Vitamin D3; and Y2 (available from Ocean Pharmaceutical).

[0159] The formulations of the present disclosure may also include sebum stimulating agents that can increase the production of sebum by sebaceous glands.These skin care actives are particularly useful for postmenopausal women who are deficient in sebum.Examples of sebum stimulating actives include bryonolic acid, completech's MBAC-DS, dehydroepiandrosterone (also known as DHEA), oryzanol, and mixtures thereof.

[0160] The formulations of the present disclosure may also include sebum inhibitors that can reduce the production of sebum by sebaceous glands. Examples of sebum inhibitor actives include aluminum hydroxychloride, ASEBIOL (available from Laboratories Serobiologiques), BIODERMINE (available from Sederma), cucumber extract, gugulipiu), Lichochalcone LR 15 (available from Maruzen), phloretin, PHLOROGINE (available from Secma), S-carboxymethylcysteine, Sepicontrol AS, Zingidone (UC1B), and mixtures thereof.

[0161] Formulations of the present disclosure may also include a humectant selected from the group consisting of glycerol, propylene glycol, dipropylene glycol, butylene glycol, sorbitol, honey and honey derivatives such as honeyquat, urea and urea derivatives such as hydroxyethylurea, ammonium lactate, sodium lactate, potassium lactate, pyroglutamic acid and its salts, sodium malate, polydextrose, triacetin, mannitol, polyethylene oxide, isomalt, maltitol and maltitol syrup, lactitol, xylitol, erythritol, and combinations thereof.

[0162] The formulations of the present disclosure may also include a pharma- ceutically acceptable carrier, which may be any cosmetic vehicle that is toxicologically and pharma- ceutically acceptable.Typical pharma-ceutically acceptable carriers that may be used in the compositions of the present disclosure include water, ethanol, acetone, isopropyl alcohol, stearyl alcohol, freon, polyvinylpyrrolidone, propylene glycol, polyethylene glycol, fragrance, gel-forming materials, mineral oil, stearic acid, spermaceti, sorbitan, monooleate, polysorbate, "Tween", sorbitol, methylcellulose, petrolatum, mineral oil (wax), and the like. serine oil) (which may be any petroleum-based product); modified or unmodified vegetable oils, such as peanut oil, wheat germ oil, linseed oil, jojoba oil, apricot kernel oil, walnut oil, coconut oil, pistachio oil, sesame oil, rapeseed oil, cade oil, corn germ oil, peach kernel oil, poppy seed oil, pine oil, castor oil, soybean oil, safflower oil, coconut oil, hazelnut oil, grape seed oil, avocado oil, soybean oil, sweet almond oil, calophyllum oil, castor oil, olive oil, castor ... oils of animal origin, such as whale oil, seal oil, menhaden oil, halibut liver oil, cod liver oil, cod, tuna, turtle oil, horse hoof, sheep's foot, mink, otter, marmot oil, etc.; synthetic oils, such as silicone oils, such as dimethylpolysiloxane; alkyl and alkenyl esters of fatty acids, such as the isopropyl esters of myristic acid, palmitic acid and stearic acid, and fatty acid esters which are solid at room temperature; waxes, such as lanolin wax, candelilla wax, spermaceti, cocoa butter, karite butter, silicone wax, hydrogenated oils which are solid at room temperature, sucroglycerides, oleates, myristates, linoleates, stearates, paraffin, beeswax, carnauba wax, ozokerite, candelilla wax, microcrystalline wax; fatty alcohols, such as lauryl, cetyl, myristyl, stearyl, palmityl and oleyl alcohol; polyoxyethylated fatty alcohols;and wax esters, lanolin and its derivatives, perhydrosqualene and saturated esters, alkyl myristates such as ethyl palmitate, isopropyl palmitate, isopropyl myristate, butyl myristate and decyl myristate, hexyl stearate, triglyceride esters, octanoic and decanoic triglycerides, cetyl ricinoleate, stearyl octanoate (Purcellin oil), fatty acids, polyhydric alcohols, polyether derivatives, fatty acid monoglycerides, polyethylene glycol, propylene glycol, alkyl ethoxy ether sulfonates, ammonium alkyl sulfonates, fatty acid soaps and hydrogenated polyisobutene, and mixtures of waxes and oils;

[0163] The formulation of the present disclosure may also include a solvent.In some embodiments, the solvent is selected from the group consisting of water, ethanol, isopropyl alcohol, water, dimethyl ether, diethyl ether, butane, propane, isobutene, 1,1-difluoroethane, 1,1,1,2 tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, 1,1,1,3,3,3 hexafluoropropane, ethyl acetate, acetone, iso-amyl acetate, denatured alcohol, methanol, propanol, isobutene, pentane, hexane, chlorbutanol, turpentine oil, cytopentasiloxane, cyclomethicone, methyl ethyl ketone, and combinations thereof. In other embodiments, the solvent is 1,2,6-hexanetriol, alkyltriols, alkyldiols, acetyl monoglycerides, tocopherols, alkyldioxolanes, p-propenylanisole, anise oil, apricot oil, dimethylisosorbide, alkylglucosides, benzyl alcohol, beeswax, benzyl benzoate, butylene glycol, caprylic / capric triglyceride, caramel, cassia oil, castor oil, cinnamaldehyde, cinnamon oil, clove oil, coconut oil, cocoa butter, cocoa glycerides, coriander oil, corn oil, coriander oil, corn syrup, cottonseed oil, cresol, cyclomethicone, diacetin, diacetylated monoglycerides, diethanolamine, diethylene glycol monoethyl ether, diglycerides, ethyl Lactone glycol, eucalyptus oil, fats and oils, fatty alcohols, flavors, liquid sugar, ginger extract, glycerin, high fructose corn syrup, hydrogenated castor oil, IP palmitate, lemon oil, lime oil, limonene, milk, monoacetin, monoglycerides, nutmeg oil, octylodocanol, olive alcohol, orange oil, coconut oil, peanut oil, PEG vegetable oil, peppermint oil, petrolatum, phenol, pine needle oil, polypropylene glycol, sesame oil, spearmint oil, soybean oil, vegetable oil, vegetable shortening, vinyl acetate, wax, 2-(2-(octadecyloxy)ethoxy)ethanol, benzyl benzoate, butylated hydroxyanisole, candelilla wax, carnauba wax, ceteareth-20, cetyl alcohol, polyglyceryl, dipolyhydroxystearate,PEG-7 hydrogenated castor oil, diethyl phthalate, diethyl sebacate, dimethicone, dimethyl phthalate, PEG fatty acid esters, PEG stearate, PEG oleate, PEG laurate, PEG fatty acid diesters, PEG dioleate, PEG stearate-diester, PEG castor oil, glyceryl behenate, PEG glycerol fatty acid esters, PEG glyceryl laurate, PEG glyceryl stearate, PEG glyceryl oleate, hexylene glycerol, lanolin, larodiethanolamide, lauryl lactate, lauryl lauryl sulfate, medronic acid, methacrylic acid, multisterol extract, myristyl alcohol, neutral oil, PEG-octylphenyl ether, PEG-alkyl ethers, PEG-cetyl ether, PEG-stearyl ether, PEG-sorbitan fatty acid esters, PEG-sorbitan diisostearate, PEG-sorbitan monostearate, propylene glycol fatty acid esters, propylene glycol stearate, propylene glycol Licorice, Caprylic / Capric Acid, Sodium Pyrrolidone Carboxylate, Sorbitol, Squalene, Stear-o-Wet, Triglycerides, Alkylaryl Polyether Alcohols, Polyoxyethylene Derivatives of Sorbitan Ether, Saturated Polyglycolized C8-C10 Glycerides, N-Methylpyrrolidone, Honey, Polyoxyethylated Glycerides, Dimethyl Sulfoxide, Azone and Related Compounds, Dimethylformamide, N-Methylformamide, Fatty Acid Esters, Fatty Alcohol Ethers, Alkylamides (N,N-Dimethylalkylamides), N-Methylpyrrolidone Related Compounds, Ethyl Oleate, Polyglycerinated Fatty Acids, Glycerol Monooleate, Glyceryl Monomyristate, Fatty Acid Glycerol Esters, Silk Amino Acids, PPG-3 Benzyl Ether Myristate, Di-PPG 2 Myreth 10 Adipate, Honeycut, Sodium Pyroglutamate, Abyssinica Oil, Dimethicone, Macadamia Nut Oil, Meadowfoam (Limnanthes alba (sea buckthorn) seed oil, cetearyl alcohol, PEG-50 shea butter, shea butter, aloe vera juice, phenyl trimethicone, hydrolyzed wheat protein, and combinations thereof.

[0164] When present, the solvent is present in an amount of about 0.01-25% by weight, 0.01-20% by weight, 0.01-15% by weight, 0.01-10% by weight, about 0.01-5% by weight, about 0.01-1% by weight, 0.1-25% by weight, 0.1-20% by weight, 0.1-15% by weight, 0.1-10% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.5-1% by weight, about 0.01-0.05% by weight, about 0.05-0.1% by weight, about 0.1-0.15% by weight, about 0.15-0.2% by weight, about 0.2-0.25% by weight, about 0.25-0.3% by weight, about 0.3-0.35% by weight, about 0.35-0.4% by weight, or about 0.4-0.5% by weight, based on the total weight of the formulation. In some embodiments, the glycerol may be present in a concentration of about 0.45%, about 0.45-0.5%, about 0.5-0.55%, about 0.55-0.6%, about 0.6-0.65%, about 0.65-0.7%, about 0.7-0.75%, about 0.75-0.8%, about 0.8-0.85%, about 0.85-0.9%, about 0.9-0.95%, about 0.95-1%, about 1-1.5%, about 1.5-2%, about 2-3%, about 3-4%, about 4-5%, about 5-6%, about 6-7%, about 7-8%, about 8-9%, about 9-10%, about 10-15%, about 15-20%, or about 20-30% by weight.

[0165] The formulations of the present disclosure may contain nutrients and amino acids, such as alanine, arginine, asparagine, aspartic acid, cysteine, cystine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, minerals and vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, vitamin K, and derivatives, combinations, and mixtures thereof.The formulations of the present disclosure may also contain eucalyptus oil, synthetic camphor, peppermint oil, clove oil, olive oil, flavors such as lavender, chamomile, flavors such as chocolate, vanilla, mint, and derivatives, combinations, and mixtures thereof.The formulations of the present disclosure may also contain other food additives that are commonly contained in supplements, such as gelatin, rice, flour, wheat, citric acid, natural and artificial flavors, derivatives, combinations, and mixtures thereof.

[0166] The formulation also contains ascorbic acid, ascorbic acid derivatives, glucosamine ascorbate, arginine ascorbate, lysine ascorbate, glutathione ascorbate, nicotinamide ascorbate, niacin ascorbate, allantoin ascorbate, creatine ascorbate, creatinine ascorbate, chondroitin ascorbate, chitosan ascorbate, DNA ascorbate, carnosine ascorbate, vitamin E, various vitamin E derivatives, tocotrienols, rutin, quercetin, hesperedin (Citrus sinensis), diosmin (Citrus sinensis), mangiferin (Mangifera indica), mangosteen (Garcinia mangostana), cyanidin (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes patula), lycopene (Lycopersicum esculentum), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (Curcuma longa), rosmarinic acid (Rosmarinus officinalis), hypericin (Hypericum perforatum), ellagic acid (Pomegranate Punica granatum), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, niacinamide, lipoic acid, glutathione, andrographolide (Andrographis The compositions may include antioxidant ingredients and compositions selected from, but not limited to, sodium lauryl sulfate, sodium phosphate dibenzoate, sodium lauryl sulfate ...The antioxidants may be present, individually or cumulatively, in an amount of from about 0.001-0.01 wt%, about 0.01-0.05 wt%, about 0.05-0.1 wt%, about 0.1-0.15 wt%, about 0.15-0.2 wt%, about 0.2-0.25 wt%, about 0.25-0.3 wt%, about 0.3-0.35 wt%, about 0.35-0.4 wt%, or about 0.4-0.45 wt%, to about 0.45-0.5 wt%, about 0.5-0.55 wt%, about 0.55-0.6 wt%, about 0.6-0.65 wt%, about 0. It may be present in a concentration of up to any of the following: about 0.65-0.7%, about 0.7-0.75%, about 0.75-0.8%, about 0.8-0.85%, about 0.85-0.9%, about 0.9-0.95%, about 0.95-1%, about 1-1.5%, about 1.5-2%, about 2-3%, about 3-4%, about 4-5%, about 5-6%, about 6-7%, about 7-8%, about 8-9%, about 9-10%, about 10-15%, about 15-20%, or about 20-30% by weight.

[0167] The formulation also contains Horse Chestnut Extract (Aesculus hippocastanum extract), Esculin, Escin, Yohimbine, Capsicum Oleoresin, Capsaicin, Niacin, Niacin Esters, Methyl Nicotinate, Benzyl Nicotinate, Ruscogenin (Butcher's Broom Extract; Ruscus aculeatus Extract), Diosgenin (Trigonella foenumgraecum, Fenugreek), Emblica Extract (Phyllanthus emblica extract), Asiaticoside (Centella asiatica extract), Boswellia Extract (Boswellia serrata), Ginger Root Extract (Zingiber Officianalis), Piperine, Vitamin K, Melilot (Melilotus officinalis extract), glycyrrhetinic acid, ursolic acid, sericoside (Terminalia sericea extract), daltoside (Siegesbeckia orientalis extract), ammibisnaga extract, red grape (Vitis Vinifera) leaf extract, apigenin, phytosan, luteolin, and combinations thereof.

[0168] The formulation may also contain at least one antioxidant class of cyclooxygenase (e.g., COX-1 or COX-2) or lipoxygenase (e.g., LOX-5) enzyme inhibitors, such as ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperedin (Citrus sinensis), diosmin (Citrus sinensis), mangiferin (Mangifera indica), mangosteen (Garcinia mangostana), cyanidin (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes patula), lycopene (Lycopersicum), or the like. esculentum), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (Curcuma longa), rosmarinic acid (Rosmarinus officinalis), hypericin (Hypericum perforatum), ellagic acid (Punica granatum), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, pycnogenol (pine bark extract), white tea extract, black tea extract, (Andrographis paniculata), carnosine, niacinamide and emblica extract.The anti-inflammatory composition may further comprise any of the following compounds: Horse Chestnut Extract (Aesculus hippocastanum extract), Esculin, Escin, Yohimbine, Capsicum Oleoresin, Capsaicin, Niacin, Niacin Esters, Methyl Nicotinate, Benzyl Nicotinate, Ruscogenin (Butcher's Broom Extract; Ruscus aculeatus Extract), Diosgenin (Trigonella foenumgraecum, Fenugreek), Emblica Extract (Phyllanthus emblica extract), Asiaticoside (Centella asiatica extract), Boswellia Extract (Boswellia serrata), Sericoside, Visnadin, Thiocolchicoside, Grape Seed Extract, Thiozinha Root Extract (Zingiber officinale), Officianalis), piperine, vitamin K, melilot (Melilotus officinalis extract), glycyrrhetinic acid, ursolic acid, sericoside (Terminalia sericea extract), daltoside (Siegesbeckia orientalis extract), ammibisnaga extract, red grape (Vitis Vinifera) leaf extract, apigenin, phytosan, luteolin, and combinations thereof.

[0169] Certain divalent and polyvalent metal ions may also be present in the compositions of the present disclosure. Examples of such metal ions include zinc, copper, manganese, vanadium, chromium, cobalt, and iron.

[0170] The formulations may also include colorants, such as zinc oxide (white), titanium dioxide (white), calcium carbonate, kaolin, blue, green, orange, red, purple, yellow and black pigments. The formulations may also include mixtures and combinations of any of the above, as well as one or more active ingredients in addition to a therapeutically effective dose of the active ingredient, such as, but not limited to, other therapeutic agents for the prevention and treatment of one or more conditions or disease states.

[0171] The formulations of the present disclosure may also include a skin lightening agent selected from the group consisting of hydroquinone, arbutin, hydroquinone derivatives, paper mulberry extract (Broussonetia kazinoke), mitracarpa extract (Mitracarpus scaber), bearberry extract (Arctostaphylos uva ursi), yellow dock extract (Rumex crispus and Rumex occidentalis), glutathione, white blood cell extract, Aspergillus orizae), licorice extract (Glycyrrhiza glabra), rosmarinic acid (Rosmarinus officinalis), and the like. officinalis), Tetrahydrocurcumin, Green Tea Extract (Camellia sinensis), Yohimbe Extract (Pausinystalia yohimbe), Ecklonia cava Extract, Niacinamide, Hydroxytetronic Acid, Spondias mombin Extract, Maprounea guianensis Extract, Walteria indica Extract, Gouania blanchetiana Extract, Cordia schomburgkii Extract, Randia armata Extract, Hibiscus yangianus Extract furcellatus) extract, 2-hydroxyacetophenone, 3-hydroxyacetophenone, 4-hydroxyacetophenone, 2,3-dihydroxyacetophenone, 2,4-dihydroxyacetophenone, 2,5-dihydroxyacetophenone, 2,6-dihydroxyacetophenone, 3,4-dihydroxyacetophenone, 3,5-dihydroxyacetophenone, 2,4,6-trihydroxyacetophenone, 2,3,4-trihydroxyacetophenone, 2,3,5-trihydroxyacetophenone, 2,3,6-trihydroxyacetophenone, 2,4,5-trihydroxyacetophenone, 3,4,5-trihydroxyacetophenone, resacetophenone, 2-acetylresorcinol, 4-acetylresorcinol, 3,4-dihydroxyacetophenone, acetylquinol, quinacetophenone, 1-(3-hydroxy-4-methoxy-5-methylphenyl)ethanone, 1-(3-hydroxy-4-methoxyphenyl)ethanone, paeonol, 5'-bromo-2'-hydroxyacetophenone, 5'-chloro-2'-hydroxyacetophenone, 3',5'-dichloro-2'-hydroxyacetophenone, 3',5'-dibromo-4'-hydroxyacetophenone, 5-chloro-3-bromo-2-hydroxyacetophenone, and combinations thereof. The amount of such compositions may be a safe and effective amount as needed and is not limited to any particular limit.

[0172] Formulations of the present disclosure may also include sun protection ingredients having an SPF of 6 to 95. Sun protection ingredients include, but are not limited to, octyl methoxycinnamate (ethylhexyl p-methoxycinnamate), octyl salicylate oxybenzone (benzophenone-3), benzophenone-4, menthyl anthranilate, dioxybenzone, aminobenzoic acid, amyl dimethyl PABA, diethanolamine p-methoxycinnamate, ethyl 4-bis(hydroxypropyl)aminobenzoate, 2-ethylhexyl 1-2-cyano-3,3-diphenylacrylate, homomenthyl salicylate, glyceryl aminobenzoate, dihydroxyacetone, octyl dimethyl PABA, 2-phenylbenzimidazole-5-sulfonic acid, triethanolamine salicylate, zinc oxide, and titanium dioxide, and mixtures thereof. The amount of sunscreen used in the cosmetically acceptable compositions of the present disclosure may vary depending on the specific UV absorption wavelength of the particular sunscreen active used, and may be from about 0.1 to about 10 weight percent, from about 2 to about 8 weight percent. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of about 0.1% to about 60.0%. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of about 0.1% to about 80.0%. In one embodiment, the active ingredient is present in the formulation of the present disclosure at a concentration of about 1.0% to about 50.0% for topical and transdermal applications, and about 50% to 98% for oral formulations.

[0173] The formulations of the present disclosure may also include analgesics such as lanocaine, lidocaine, prilocaine, salicylates, NSAIDs, acetaminophen, capsaicin, camphor, menthol, methyl salicylate, methyl nicotinate, ketamine and trolamine salicylate.

[0174] The formulations of the present disclosure may also include agents for wound healing, such as apain, trypsin, allantoin, chymotrypsin, streptokinase, streptodornase, ficin, pepsin, carboxypeptidase, aminopeptidase, chymopapain, and bromelin.

[0175] Formulations of the present disclosure may also include anti-infectives such as bacitracin, polymyxin B, mupirocin, neomycin, tetracyclines (chlortetracycline hydrochloride, oxytetracycline hydrochloride and tetracycline hydrochloride), clindamycin, gentamicin sulfate, benzalkonium chloride, benzethonium chloride, hexylresorcinol, methylbenzethonium chloride, and phenol.

[0176] Formulations of the present disclosure may also include preservatives such as thymol, menthol, benzalkonium chloride, chlorhexidine gluconate, and natural oils, including tea tree oil.

[0177] Formulations of the present disclosure may also include astringents and drying agents, such as calamine, witch hazel, sodium bicarbonate, aluminum hydroxide, and zinc oxide.

[0178] Formulations of the present disclosure may also include antifungal agents such as miconazole, econazole, tolnaftate, ketoconazole, undecylenic acid, amphotericin, carbol-fuchsin, ciclopirox, clotrimazole, haloprogin, mafenide, naftifine, nystatin, oxiconazole, silver, sulfadiazine, sulconazole, terbinafine, tioconazole, undecylenic acid antiacne salicylic acid, benzoyl peroxide, acne, rosacea, seborheic resorcinol, sulfur, dermatitis sodium sulfacetamide, retinoic acid, isotretinoin, erythromycin, zinc, retinol, citric acid, and alpha hydroxy acids.

[0179] In certain embodiments, retinol is included in the delivery systems described herein and is present in an amount of about 0.01-10% by weight, about 0.01-5% by weight, about 0.01-4% by weight, about 0.01-3% by weight, about 0.01-2% by weight, about 0.01-1% by weight, about 0.1-5% by weight, about 0.1-4% by weight, about 0.1-3% by weight, about 0.1-2% by weight, about 0.1-1% by weight, based on the total weight of retinol and its derivatives in the delivery systems described herein. %, about 1-10%, about 10-20%, about 20-30%, about 30-40%, about 40-50%, about 50-60%, about 60-70%, about 70-80%, about 80-85%, about 85-90%, about 90-95%, about 95-96%, about 96-97%, about 97-98%, about 98-99%, about 99-99.5%, or about 99.5% by weight of retinol.

[0180] Formulations of the present disclosure may also include antiviral agents such as acyclovir, docosanol, penciclovir, cidofovir, desciclovir, famciclovir, ganciclovir, lobucavir, PMEA, valacyclovir, 2242, PAA, PFA, H2G, sorivudine, trifluridine, tromantadine, adenine, arabinoside, arabinosyl adenine monophosphate, and lobucavir.

[0181] Formulations of the present disclosure may also include immunomodulators such as pimecrolimus, tacrolimus, muramyl dipeptide, cyclosporine, interferons (including alpha, beta, and gamma interferon), interleukin-2, cytokines, tumor necrosis factor, pentostatin, thymopentin, transforming factor beta 2, and erythropoietin.

[0182] Formulations of the present disclosure may also include detergents, such as ammonium lauryl sulfate, cold cream, glycerin, glycolic or salicylic acid, sodium bicarbonate, calcium carbonate, magnesium hydroxide, aluminum hydroxide, sodium hydroxide, polyethylene beads, aluminum oxide, synthetic detergent cleaners, bicarbonate of soda, waxes, and minerals including borax-based cleaners, or combinations thereof.

[0183] In certain embodiments, the composition comprises yellow petrolatum, yellow 5 lake, petrolatum, white petrolatum, or combinations thereof, In certain embodiments, the petrolatum is present in a concentration of about 10-15%, 15-20%, 20-30%, 30-40%, 40-50%, 50-60%, 60-70%, 70-80%, 80-90%, 90-95%, 95-98% by weight.

[0184] In certain embodiments, the compositions of the present disclosure include cedar leaf oil, nutmeg oil, special petrolatum, thymol, turpentine oil, fragrance, or combinations thereof.

[0185] In certain embodiments, the compositions of the present disclosure include camphor 4%-5% (cough suppressant and topical pain reliever), eucalyptus oil (1-5%) (cough suppressant), menthol 1-5% (cough suppressant and topical pain reliever), or combinations thereof.

[0186] In certain embodiments, the composition comprises deionized water, glycerin, petrolatum, distearyldimonium chloride, isopropyl palmitate, cetyl alcohol, dimethicone, allantoin, T36-C5, melaleuca oil, benzyl alcohol, or a combination thereof. In certain embodiments, the composition comprises mineral oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol, or a combination thereof. In certain embodiments, the composition comprises caprylic / capric triglyceride, Persea Gratissima (avocado) oil, microcrystalline wax, beeswax, Butyrospermum Parkii (shea) butter, tocopherol, panthenol, glycerin, bisabolol, or a combination thereof. In certain embodiments, the composition comprises hydrocortisone in a concentration range of about 0.5-1.5%, 1.5-3%, 3-5%, 5-10%, 10-15%, or 15-20% by weight based on the total weight of the formulation.

[0187] In certain embodiments, the composition comprises petrolatum, mineral oil, ceresin, lanolin alcohol, panthenol, glycerin, bisabolol, menthoxypropanediol, or combinations thereof.

[0188] In certain embodiments, the composition comprises bacitracin 500 units: rescue antibiotic neomycin sulfate 3.5 mg: antibiotic polymyxin B sulfate 10,000 units: rescue antibiotic pramoxine HCl 10 mg: topical analgesic, or combinations thereof.

[0189] In certain embodiments, the composition comprises petrolatum, Gossypium Herbaceum (cotton) seed oil, Olea Europaea (olive) fruit oil, Theobroma Cacao (cocoa) seed butter, tocopheryl acetate, sodium pyruvate, or combinations thereof.

[0190] In certain embodiments, the composition comprises camphor (w / w) (1-5%) (external analgesic), menthol (w / w) (1-5%) (external analgesic), petrolatum (w / w) 10-70% (lip protectant), phenol (w / w) (0.5-1%) (external analgesic), or a combination thereof.

[0191] In certain embodiments, the composition comprises beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, Ricinus Communis seed oil (castor), saccharin, Theobroma Cacao (cocoa) seed butter, or combinations thereof.

[0192] In certain embodiments, the composition comprises dimethicone (w / w) (1-5%, e.g., 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5% or 5% by weight) (lip protectant), octinoxate (w / w)- (1-10%, e.g., 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5% or 5% by weight), includes 5% by weight, 5.5% by weight, 6% by weight, 6.5% by weight, 7% by weight, 7.5% by weight, 8% by weight, 8.5% by weight, 9% by weight, 9.5% by weight or 10% by weight) (sunscreen), octisalate (w / w)-(1-5%, e.g., 1% by weight, 1.5% by weight, 2% by weight, 2.5% by weight, 3% by weight, 3.5% by weight, 4% by weight, 4.5% by weight or 5% by weight), or a combination thereof.

[0193] In certain embodiments, the composition comprises beeswax, camphor, cetyl alcohol, cetyl palmitate, Euphorbia Cerifera (candelilla) wax, flavoring, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, polybutene, Red 6 Lake, Theobroma Cacao (cocoa) seed butter, titanium dioxide, phenoxyethanol, or combinations thereof.

[0194] In certain embodiments, the composition comprises mineral oil, paraffin, ozokerite, dimethicone, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, sodium lauroyl lactylate, proline, cholesterol, phenoxyethanol, tocopheryl acetate, tocopherol hydrolyzed hyaluronic acid, panthenol, pantolactone, phytosphingosine, xanthan gum, ethylhexylglycerin, or combinations thereof.

[0195] In certain embodiments, the composition comprises mineral oil, paraffin, ozokerite, dimethicone, hyaluronic acid, sodium hydroxide, ceramide 1, ceramide 3, ceramide 6-II, tocopheryl acetate, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, panthenol, water, L-proline, xanthan gum, or combinations thereof.

[0196] In certain embodiments, the composition includes purified water, glycerin, ceteareth-20 and cetearyl alcohol, caprylic / capric triglyceride, behentrimonium methosulfate and cetearyl alcohol, cetyl alcohol, ceramide 3, ceramides 6-11, ceramide 1, hyaluronic acid, cholesterol, petrolatum, dimethicone, potassium phosphate, dipotassium phosphate, sodium lauroyl lactylate, disodium EDTA, phenoxyethanol, methylparaben, propylparaben, phytosphingosine, carbomer, xanthan gum, or combinations thereof.

[0197] In certain embodiments, the composition comprises Aqua / Water / Eau, Glycerin, Petrolatum, Caprylic / Capric Triglyceride, Hydrogenated Vegetable Oil, Sucrose Distearate, Dextrin, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Prunus Domestica Seed Extract, or combinations thereof.

[0198] In certain embodiments, the composition comprises mineral oil, paraffin oat (Avena Sativa), (oat) kernel flour, Theobroma Cacao (cocoa), seed butter, tocopheryl acetate, or a combination thereof.

[0199] In certain embodiments, the composition comprises water (Aqua), glycerin, dimethicone, stearic acid, caprylic / capric triglyceride, glycol stearate, PEG-100 stearate, petrolatum, glyceryl stearate, caprylyl glycol, phenoxyethanol, cetyl alcohol, acrylates / C10-30 alkyl acrylate crosspolymer, triethanolamine, Helianthus annuus (Sunflower) seed oil, triolein, disodium EDTA, stearamide AMP, carbomer, titanium dioxide (CI 77891), or a combination thereof. In certain embodiments, the composition comprises vulgare (wheat germ) oil, tocopherol pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, allantoin, isopropyl palmitate, liquid paraffinum (mineral oil), isopropyl myristate, aloe barbadensis (Aloe vera) leaf extract, BHE, or a combination thereof.

[0200] In certain embodiments, the composition comprises petrolatum (10-50%, 25-60%, 50-80%), zinc oxide (5-15%, 10-25%, 15-20%, 20-30%), titanium dioxide (5-15%, 10-25%, 15-20%, 20-30%), octocrylene (5-10%, 10-15%, 15-20%), octinoxate (5-10%, 10-15%, 15-20%), or a combination thereof.

[0201] In certain embodiments, the composition includes beeswax, Betula alba (white birch) bark extract, Butyrospermum Parkii (shea butter), calendula oil, corn starch, Glycine Soja (soybean) oil, lanolin, pantothenyl ethyl ether, paraffin, propylparaben, tocopheryl acetate, or combinations thereof.

[0202] In certain embodiments, the composition comprises petrolatum, cod liver oil, lanolin, glycerin, beeswax, sorbitan sesquioleate, fragrance, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopheryl acetate, talc, or combinations thereof.

[0203] In certain embodiments, the composition comprises white petrolatum, cornstarch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (Avena Sativa) kernel extract, polysorbate 80, or combinations thereof.

[0204] In certain embodiments, the composition comprises alpha-tocopherol acetate, butylated hydroxytoluene, lanolin, lavender oil, light mineral oil, methylparaben, petrolatum, polysorbate 60, or a combination thereof.

[0205] In certain embodiments, the composition comprises mineral oil, white petrolatum, white wax, or a combination thereof.

[0206] In certain embodiments, the composition comprises alpha-tocopherol acetate, aloe vera leaf, light mineral oil, paraffin, petrolatum, or a combination thereof.

[0207] In certain embodiments, the composition comprises light mineral oil, white beeswax, white petrolatum, or a combination thereof.

[0208] In certain embodiments, the composition comprises carnauba wax, isopropyl palmitate (and) isopropyl myristate (and) Aloe Barbadensis leaf extract, lanolin, fragrance, petrolatum, sorbitan sesquioleate, tocopheryl acetate (vitamin E), or combinations thereof.

[0209] In certain embodiments, the composition comprises bismuth oxychloride, C12-15 alkyl benzoate, caprylhydroxamic acid, caprylyl glycol, cetyl PEG / PPG 10 / 1 dimethicone, cyclohexasiloxane, cyclopentasiloxane, dimethicone, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, dimethiconol, disodium EDTA, glycerin, hydrogen dimethicone, iron oxides, mica, microcrystalline wax, PEG-10 dimethicone, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, polyhydroxystearic acid, polysorbate 20, sodium chloride, stearyl dimethicone, tetrahexyldecyl ascorbate, tocopheryl acetate, triethanolamine, triethoxycaprylylsilane, water, or combinations thereof.

[0210] In certain embodiments, the composition comprises water, C12-15 alkyl benzoate, styrene / acrylates copolymer, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl PEG / PPG-10 / 1 dimethicone, dimethicone, polyhydroxystearic acid, glycerin, ethyl methicone, cetyl dimethicone, silica, chrysanthemum (feverfew) flower / leaf / stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, cetyl dimethicone / bis-vinyl dimethicone crosspolymer, acrylates / dimethicone copolymer, sodium chloride, phenoxyethanol, chlorphenesin, or combinations thereof.

[0211] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diglycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, tocopheryl acetate, or combinations thereof.

[0212] In certain embodiments, the composition comprises water, Cocos Nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, methyl dihydroabietate, Butyrospermum Parkii (shea butter), fragrance, capryloyl glycerin / sebacic acid copolymer, sodium stearoyl glutamate, cetearyl alcohol, Theobroma Cacao (cocoa) seed butter, coco-glucoside, tocopherol, microcrystalline cellulose, cellulose gum, bisabolol, cetyl alcohol, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, sodium hyaluronate, sodium gluconate, phenoxyethanol, ethylhexylglycerin, citric acid, or combinations thereof.

[0213] In certain embodiments, the composition comprises water, diisopropyl adipate, ethylhexyl palmitate, ethylhexyl stearate, cetyl PEG / PPG-10 / 1 dimethicone, glycerin, cetyl dimethicone, hydrogenated castor oil, hydrated silica, cyclopentasiloxane, polyethylene, Aloe Barbadensis leaf extract, tocopheryl acetate, Theobroma Cacao (cocoa) seed butter, beeswax, cyclohexasiloxane, triethoxycaprylylsilane, sodium chloride, DMDM ​​hydantoin, fragrance, or combinations thereof.

[0214] In certain embodiments, the composition comprises water, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene / acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone / Peg-10 / 15 crosspolymer, aluminum stearate, pentylene glycol, Peg-9 polydimethylsiloxyethyl dimethicone, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, iron oxides, Peg-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, C9-15 fluoroalcohol phosphate, Peg-9, or combinations thereof.

[0215] In certain embodiments, the composition comprises allantoin, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, dimethiconol / propyl silsesquioxane / silicate crosspolymer, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isodecyl salicylate, isopropyl isostearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propanediol, silica silylate, sodium chloride, squalane, tribehenin, tridecyl salicylate, water, or combinations thereof.

[0216] In certain embodiments, the composition comprises sunflower seed oil from Helianthus Annus, coconut oil from Cocos Nucifera, beeswax from Cera Alba, castor seed oil from Ricinus Communis, red raspberry seed oil from Rubus Idaeus, shea butter from Butyrospermum Parkii, apricot kernel oil from Prunus Armeniaca, argan kernel oil from Argania Spinosa, rose hip fruit oil from Rosa Canina, tocopherol, or combinations thereof.

[0217] In certain embodiments, the composition comprises water, cyclopentasiloxane, zinc oxide, propanediol, titanium dioxide, butylene glycol dicaprylate / dicaprate, lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone, methyl methacrylate crosspolymer, butyloctyl salicylate, caprylyl methicone, Citrus Aurantium Dulcis (Orange) Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Litsea Cubeba (Litsea Cubeba) Fruit Oil, 1,2-Hexanediol, Disteardimonium Hectorite, Magnesium Sulfate, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxycaprylylsilane, Sorbitan Caprylate, Glyceryl Caprylate, Ethylhexylglycerin, Tocopherol, or combinations thereof.

[0218] In certain embodiments, the composition comprises water, dimethicone, isododecane, C12-15 alkyl benzoate, undecane, triethylhexanoin, isohexadecane, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, styrene / acrylates copolymer, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone / PEG-10 / 15 crosspolymer, aluminum stearate, pentylene glycol, Ingredients include: PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Polyhydroxystearic Acid, Phenoxyethanol, Magnesium Sulfate, Propylene Glycol, Caprylyl Glycol, PEG-8 Laurate, Disteardimonium Hectorite, Triethoxycaprylylsilane, Diethylhexylsilanylidenemalonate, Tocopherol, Propylene Carbonate, Cassia Alata Leaf Extract, Maltodextrin, Benzoic Acid, PEG-9, or combinations thereof.

[0219] In certain embodiments, the composition includes water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl pelargonate, cetyl PEG / PPG-10 / 1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate / propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, tocopherol, or combinations thereof.

[0220] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diglycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, Avena Sativa (Oat) Kernel Oil, or combinations thereof.

[0221] In certain embodiments, the composition comprises octyldodecyl neopentanoate, C12-15 alkyl benzoate, polyethylene, paraffin, silica, neopentyl glycol diethylhexanoate, ozokerite, isopropyl myristate, adipic acid / diglycol crosspolymer, triethoxycaprylylsilane, neopentyl glycol diisostearate, caprylyl glycol, Avena Sativa (Oat) Kernel Oil, tocopheryl acetate, or combinations thereof.

[0222] In certain embodiments, the composition includes C12-15 alkyl benzoate, octyldodecyl neopentanoate, dimethicone, paraffin, ozokerite, beeswax, phenyl trimethicone, Euphorbia cerifera (candelilla) wax, polyethylene, polyhydroxystearic acid, dipropylene glycol dibenzoate, triethoxycaprylylsilane, PPG-15 stearyl ether benzoate, caprylyl glycol, ethylhexylglycerin, Avena Sativa (Oat) Kernel Flour, BHT, or combinations thereof.

[0223] In certain embodiments, the composition comprises water, isobutane, isododecane, cetyl PEG / PPG-10 / 1 dimethicone, caprylic / capric triglyceride, butyloctyl salicylate, phenoxyethanol, polyhydrostearic acid, triethoxycaprylylsilane, sodium citrate, or combinations thereof.

[0224] In certain embodiments, the composition comprises water, caprylic / capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG / PPG-10 / 1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin / isopropyl maleate / MA copolymer, sodium chloride, ethylhexyl methoxycrylene, dimethicone, phenoxyethanol, caprylyl glycol, PEG-8, alumina, glycerin, sodium citrate, tocopheryl acetate, or combinations thereof.

[0225] In certain embodiments, the composition comprises arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol, butyloctyl salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Capryloyl Glycerin / Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Flower Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Peel Oil, Scutellaria Baicalensis (Sweet Almond) ... Ingredients include: Citrus Sativus (Cucumber) Fruit Extract, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Persea Gratissima (Avocado) Fruit Extract, Prunus Armeniaca Kernel Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherols, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water Certified Organic, or combinations thereof.

[0226] In certain embodiments, the composition comprises arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol, butyloctyl salicylate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Capryloyl Glycerin / Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Flower Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Peel Oil, Scutellaria Baicalensis (Sweet Almond) ... Sativus (Cucumber) Fruit Extract, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Persea Gratissima (Avocado) Fruit Extract, Prunus Armeniaca Kernel Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherols, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water, or combinations thereof.

[0227] In certain embodiments, the composition comprises purified water, caprylic / capric triglyceride, polyglyceryl-4 isostearate, glycerin, hydrogenated glyceryl abietate, hexyl laurate, cetyl dimethicone, Aloe Barbadensis leaf juice, hydrogenated castor oil, magnesium sulfate, Helianthus Annuus (Sunflower) seed oil, Simmondsia chinensis (Jojoba) seed oil, tocopherol, Olea Europaea (Olive) fruit oil, Rubus Idaeus (Red Raspberry) seed oil, Vaccinium Macrocarpon (Cranberry) seed oil, sodium hyaluronate, Carica Papaya (Papaya) fruit extract, Ribes Nigrum (blackcurrant) extract, Citrus Paridisi (pink grapefruit) peel oil, sorbitan sesquioleate, caprylhydroxamic acid, triethoxycaprylylsilane, glyceryl caprylate, or combinations thereof.

[0228] In certain embodiments, the composition includes purified water, Aloe barbadensis leaf juice, capric caprylic triglyceride, sorbitan stearate (coconut based), pinewood resin, vegetable glycerin, cetyl dimethicone, hydrogenated castor oil, magnesium sulfate (epsom salts), sunflower oil, jojoba oil, ascorbic acid (vitamin C), tocopherol (vitamin E), olive oil, raspberry seed oil, cranberry seed oil, hyaluronic acid (vegetable based), glucose & glucose oxidase and lactoperoxidase, papaya, or combinations thereof.

[0229] In certain embodiments, the composition comprises alumina, aluminum stearate, beeswax, C12-15 alkyl benzoate, caprylyl glycol, cetyl dimethicone, cetyl PEG / PPG-10 / 1 dimethicone, chlorphenesin dimethicone disodium, EDTA, ethylhexyl palmitate, ethylhexyl stearate, hexyl laurate, hydrogenated castor oil, methyl glucose dioleate, octyldodecyl, neopentanoate, PEG-7, hydrogenated castor oil, phenoxyethanol, polyglyceryl-4 isostearate, polyhydroxystearic acid, propanediol, purified water, sorbitan oleate, stearic acid, tocopheryl acetate, trimethylsiloxysilicate, VP / hexadecene copolymer, or combinations thereof.

[0230] In certain embodiments, the composition comprises dimethicone, caprylic / capric triglyceride, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, butyloctyl salicylate, glyceryl isostearate, polyester-8, polysilicone-15, behenic acid, camellia sinensis leaf extract, caproyl phytosphingosine, ceramide AP, ceramide EOP, ceramide EOS, ceramide NP, ceramide NS, ceteareth-25, cetyl alcohol, cholesterol, glycerin, iron oxides, PEG / PPG-18 / 18 dimethicone, pomegranate extract, silica, tetrahexyldecyl ascorbate, tocopheryl acetate, triethoxycaprylylsilane, Vaccinum Macrocarpon (cranberry) fruit extract, or combinations thereof.

[0231] In certain embodiments, the composition comprises water, glycerin, C12-15 alkyl benzoate, dimethicone, isododecane, styrene / acrylates copolymer, glyceryl stearate, butyloctyl salicylate, dicaprylyl carbonate, propanediol, stearic acid, aluminum hydroxide, Peg-100 stearate, sorbitan stearate, niacinamide, Peg-8 laurate, ceramide Np, ceramide Ap, ceramide Eop, sorbitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylyl. Ingredients include: russlan, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, palmitic acid, phenoxyethanol, chlorphenesin, tocopherol, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin, or combinations thereof.

[0232] In certain embodiments, the composition comprises alumina, cyclohexasiloxane, cyclopentasiloxane, dimethicone, dimethicone crosspolymer, dimethicone / vinyl dimethicone crosspolymer, dimethiconol, lauryl PEG / PPG-18 / 18 methicone, methicone, PEG-10 dimethicone, or combinations thereof.

[0233] In certain embodiments, the composition comprises Aqua, Cocos Nucifera (Coconut Oil), Persea Gratissima (Avocado Oil), Cetearyl Alcohol / Polysorbate 60 (Vegetable Emulsifying Wax NF), Butyrospernum Parkii (Shea Butter), Rubus Idaeus (Red Raspberry Seed Oil), Glyceryl Oleate Citrate & Caprylic / Capric Triglyceride, Glycerin, Cera Alba (Beeswax), Ethylhexylglycerin & Propanediol, Polyhydroxystearic Acid, Sodium Gluconate, Cocos Nucifera (Coconut Essential Oil), Vanilla Plantifolia (Vanilla Essential Oil), or combinations thereof.

[0234] In certain embodiments, the composition comprises organic sunflower oil, organic beeswax, sunflower vitamin E, or a combination thereof.

[0235] In certain embodiments, the composition comprises Helianthus Annuus (sunflower) seed oil, Cera Alba (beeswax), tocopherol (sunflower vitamin E), or a combination thereof.

[0236] In certain embodiments, the composition comprises petrolatum, coconut alkane, coco-caprylate / caprate, and an analgesic. In certain embodiments, the composition comprises petrolatum, coconut alkane, coco-caprylate / caprate, and lidocaine. In some embodiments, the composition is in the form of a radiation spray.

[0237] In certain embodiments, the composition includes petrolatum, coconut alkane, coco-caprylate / caprate, camphor (tussive suppressant and topical analgesic), menthol (tussive suppressant and topical analgesic), and Eucalyptus Globulus leaf oil.

[0238] In certain embodiments, the composition includes petrolatum, coconut alkanes, coco-caprylate / caprate, camphor (tussive and topical analgesic), menthol (tussive and topical analgesic), Eucalyptus Globulus, Myristica Fragrans (nutmeg) kernel oil, turpentine, C18-C36 acid triglycerides, jojoba esters, C12-C18 acid triglycerides, squalene, thymol, phytosteryl macadamiate, phytosterols, and tocopherols. In some embodiments, the composition is in the form of a vapor spray.

[0239] In certain embodiments, the composition comprises a polyol or diol.Exemplary diols may include, but are not limited to, one or more of propylene glycol, propanediol, butanediol, butenediol, butynediol, pentanediol, hexanediol, octanediol, neopentyl glycol, 2-methyl-1,3-propanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, dipropylene glycol, dibutylene glycol, isopentyl diol, ethoxydiglycol, or combinations thereof. The diol included in the delivery systems described herein is present in a concentration of about 1-25%, about 0.1-10%, about 0.1-5%, about 0.1-1%, about 1-5%, about 1-10%, about 5-10%, about 1-15%, about 10-15%, about 15-20%, about 20-25%, about 25-30%, about 30-35%, about 35-40%, about 40-45%, about 45-50%, about 50-55%, about 55-60%, about 60-65%, about 65-70%, about 70-75%, about 75-80%, about 80-85%, about 85-90%, or about 90-95% by weight based on the total weight of the composition. For example, the diol can be present in a concentration of about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt%, about 6 wt%, about 7 wt%, about 8 wt%, about 9 wt%, about 10 wt%, about 11 wt%, about 12 wt%, about 13 wt%, about 14 wt%, about 15 wt%, about 16 wt%, about 17 wt%, about 18 wt%, about 19 wt%, about 20 wt%, about 21 wt%, about 22 wt%, about 23 wt%, about 24 wt%, or about 25 wt%, based on the total weight of the composition.

[0240] In certain embodiments, the composition comprises bactiol in an amount of about 0.01-10%, about 0.01-1%, about 0.01-1%, about 0.1-0.3%, about 0.3-0.5%, about 0.5-0.7%, about 0.7-1%, or about 1-3%, about 3-5%, about 5-7%, about 7-10%, about 10-15%, about 15-20%, or about 20-25% by weight based on the total weight of the composition.

[0241] In certain embodiments, the composition comprises water (Aqua) in an amount of about 0.001-25% by weight based on the weight of the formulation. For example, the composition may comprise water in a concentration range of about 0.1-25% by weight based on the weight of the formulation. For example, the composition may comprise water (Aqua) in an amount of about 0.1-20%, about 0.1-15% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, about 7-10% by weight, about 10-15% by weight, about 15-20% by weight, or about 20-25% by weight based on the total weight of the formulation.

[0242] In certain embodiments, the composition comprises caprylic / capric triglyceride in an amount of about 0.001-25% by weight based on the weight of the formulation. For example, the composition may comprise a concentration range of about 0.1-25% by weight based on the weight of the formulation. For example, the composition may contain about 0.1-20%, about 0.1-15%, about 0.1-10%, about 0.1-5%, about 0.1-1%, about 0.1-0.5%, about 0.1-0.3%, about 0.3-0.5%, about 0.5-0.7%, about 0.7-1%, or about 1-3%, about 3-5%, about 5-7%, about 7-10%, about 10-15%, about 15-20%, or about 20-25% by weight of caprylic / capric triglyceride based on the total weight of the formulation.

[0243] In certain embodiments, the composition contains glycerin in an amount of about 0.001-25% by weight based on the weight of the formulation. For example, the composition may contain a concentration range of about 0.1-25% by weight based on the weight of the formulation. For example, the composition may contain about 0.1-20%, about 0.1-15% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, about 7-10% by weight, about 10-15% by weight, about 15-20% by weight, or about 20-25% by weight of glycerin based on the total weight of the formulation.

[0244] In certain embodiments, the composition comprises methyl dihydroabietate in an amount of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may comprise about 0.01-1% by weight, about 0.01-0.5% by weight, about 0.01-0.1% by weight, about 0.01-0.05% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of methyl dihydroabietate based on the total weight of the formulation.

[0245] In certain embodiments, the composition comprises cetearyl alcohol in an amount of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may comprise about 0.01-1% by weight, about 0.01-0.5% by weight, about 0.01-0.1% by weight, about 0.01-0.05% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of cetearyl alcohol based on the total weight of the formulation.

[0246] In certain embodiments, the composition contains bisabolol in an amount of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may contain about 0.01-1% by weight, about 0.01-0.5% by weight, about 0.01-0.1% by weight, about 0.01-0.05% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of bisabolol based on the total weight of the formulation.

[0247] In certain embodiments, the composition comprises lactic acid in an amount of about 0.001-10% by weight based on the weight of the formulation. For example, the composition may contain about 0.001-1 wt%, about 0.001-0.5 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.01 wt%, about 0.001-0.005 wt%, about 0.001-0.003 wt%, about 0.001-0.002 wt%, 0.1-10%, about 0.1-5%, about 0.1-5%, about 0.1-1%, about 0.1-0.5%, about 0.1-0.3 wt%, about 0.3-0.5 wt%, about 0.5-0.7 wt%, about 0.7-1 wt%, or about 1-3 wt%, about 3-5 wt%, about 5-7 wt%, or about 7-10 wt% lactic acid based on the total weight of the formulation.

[0248] In certain embodiments, the composition comprises citric acid in an amount of about 0.001-10% by weight based on the weight of the formulation. For example, the composition may contain about 0.001-1 wt%, about 0.001-0.5 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.01 wt%, about 0.001-0.005 wt%, about 0.001-0.003 wt%, about 0.001-0.002 wt%, 0.1-10%, about 0.1-5%, about 0.1-5%, about 0.1-1%, about 0.1-0.5%, about 0.1-0.3 wt%, about 0.3-0.5 wt%, about 0.5-0.7 wt%, about 0.7-1 wt%, or about 1-3 wt%, about 3-5 wt%, about 5-7 wt%, or about 7-10 wt% of citric acid based on the total weight of the formulation.

[0249] In certain embodiments, the composition comprises coco-glucoside in an amount of about 0.001-1% by weight based on the weight of the formulation. For example, the composition may contain, based on the weight of the formulation, about 0.001-0.01 wt%, about 0.001-0.5 wt%, about 0.001-0.4 wt%, about 0.001-0.3 wt%, about 0.001-0.25 wt%, about 0.001-0.2 wt%, about 0.001-0.15 wt%, about 0.001-0.1 wt%, about 0.001-0.05 wt%, about 0.001-0.04 wt%, about 0.001-0.03 wt%, about 0.001-0.01 wt%, about 0.001-0.025 wt%, about 0.001-0.02 wt%, about 0.001-0.015 wt%, about 0.005-0.01 wt%, about 0.01-0.05 %, about 0.05-0.1%, about 0.1-0.15%, about 0.15-0.2%, about 0.2-0.25%, about 0.25-0.3%, about 0.3-0.35%, about 0.35-0.4% or about 0.4-0.45%, about 0.45-0.5%, about 0.5-0.55%, about 0.55-0.6%, about 0.6-0.65%, about 0.65-0.7%, about 0.7-0.75%, about 0.75-0.8%, about 0.8-0.85%, about 0.85-0.9%, about 0.9-0.95%, or about 0.95-1% by weight of coco-glucoside.

[0250] In some embodiments, the composition comprises glucan. In some embodiments, the composition comprises beta-glucan. In some embodiments, the composition comprises sodium carboxymethyl beta-glucan in a concentration range of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may comprise about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of beta-glucan based on the total weight of the formulation.

[0251] In certain embodiments, the composition comprises isohexadecane in an amount of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may comprise about 0.01-1% by weight, about 0.01-0.5% by weight, about 0.01-0.1% by weight, about 0.01-0.05% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of isohexadecane based on the total weight of the formulation. In certain embodiments, the composition comprises 30-60% by weight of isohexadecane. In one particular embodiment, the composition comprises 45% by weight of isohexadecane.

[0252] In certain embodiments, the composition comprises silica in an amount of about 0.01-10% by weight based on the weight of the formulation. For example, the composition may comprise about 0.01-1% by weight, about 0.01-0.5% by weight, about 0.01-0.1% by weight, about 0.01-0.05% by weight, about 0.1-10% by weight, about 0.1-5% by weight, about 0.1-5% by weight, about 0.1-1% by weight, about 0.1-0.5% by weight, about 0.1-0.3% by weight, about 0.3-0.5% by weight, about 0.5-0.7% by weight, about 0.7-1% by weight, or about 1-3% by weight, about 3-5% by weight, about 5-7% by weight, or about 7-10% by weight of silica based on the total weight of the formulation.

[0253] In some embodiments, the composition comprises any one or more of caprylhydroxamic acid, polyhydroxystearic acid, bentonite, ethylhexylglycerin, heptyl undecylenate, hexylene glycol, cetyl glyceryl ether, caprylyl glycol, or phenoxyethanol. In certain embodiments, the composition comprises any one or more of caprylhydroxamic acid, polyhydroxystearic acid, bentonite, ethylhexylglycerin, heptyl undecylenate, hexylene glycol, cetyl glyceryl ether, caprylyl glycol, or phenoxyethanol, individually or collectively, in an amount of about 0.001-1% by weight based on the weight of the formulation. For example, the composition may contain, based on the weight of the formulation, about 0.001 to 0.01% by weight, about 0.001 to 0.5% by weight, about 0.001 to 0.4% by weight, about 0.001 to 0.3% by weight, about 0.001 to 0.25% by weight, about 0.001 to 0.2% by weight, about 0.001 to 0.15% by weight, about 0.001 to 0.1% by weight, about 0.001 to 0.05% by weight, about 0.001 to 0.04% by weight, about 0.001 to 0.03% by weight, about 0.001 to 0.01% by weight, about 0.001 to 0.025% by weight, about 0.001 to 0.02% by weight, about 0.001 to 0.015% by weight, about 0.005 to 0.01% by weight, about 0. ...1 to 0.02% by weight, about 0.01 to 0.02% by weight, about 0.01 to 0.02% by weight, about 0.01 to 0.0 It may comprise 0.05% by weight, about 0.05-0.1% by weight, about 0.1-0.15% by weight, about 0.15-0.2% by weight, about 0.2-0.25% by weight, about 0.25-0.3% by weight, about 0.3-0.35% by weight, about 0.35-0.4% by weight or about 0.4-0.45% by weight, about 0.45-0.5% by weight, about 0.5-0.55% by weight, about 0.55-0.6% by weight, about 0.6-0.65% by weight, about 0.65-0.7% by weight, about 0.7-0.75% by weight, about 0.75-0.8% by weight, about 0.8-0.85% by weight, about 0.85-0.9% by weight, about 0.9-0.95% by weight, or about 0.95-1% by weight.

[0254] In certain embodiments, the composition is packaged in a spray delivery system that provides a mist or spray, such as a canned aerosol system.Optionally, spray barrier formulations can be packaged in a bag-on-valve aerosol system.In certain embodiments, the product is delivered by a system that separates the formulation from the propellant.Those skilled in the art will understand that there are several known methods of mixing components to obtain a sprayable composition, and the procedure described should not be considered as limiting the scope of the present disclosure.

[0255] In certain embodiments, the viscosity of the petrolatum used in the formulations is about 150,000 centipoise at 25° C. An exemplary viscosity range for petrolatum used in the formulations of the present disclosure is about 20,000 centipoise to 600,000 centipoise at 25° C.

[0256] In certain embodiments, the compositions disclosed herein have low viscosity so that the composition can be applied in the form of a mist from a spray bottle having a spray pump or container with a spray head to a desired body part, including but not limited to the face, lips, legs, face, etc. In certain embodiments, the spray pump bottle is configured to spray a mist of the composition onto the skin of the user. In certain aspects, the spray pump bottle is configured to spray a mist.

[0257] In certain embodiments, the disclosed compositions have a viscosity of 3-500 centipoise ("cP"), 3-100 cP, 3-75 cP, 3-40 cP, 3-10 cP, 3-5 cP, 500-1,000 cP, 1,000-5000 cP, or 5,000-7,000 cP at temperatures ranging from 65°F to 100°F, 70°F to 85°F, and 72°F to 80°F.

[0258] In certain embodiments, the sprayable formulation has a particle size of 50-100 microns, 10-50 microns, 5-10 microns or 1-5 microns.

[0259] In certain embodiments, water is included at a concentration of 1-70%, 1-15%, 1-10%, 2-65%, 2-8%, 2-6%, 3-60%, or 3-5% by weight of the total composition to further aid in the solubility and dispersibility of the composition, for example, by reducing the viscosity of the overall composition. In certain embodiments, water aids in solubilizing the various components and also acts synergistically to moisturize and help hydrate the skin of the user.

[0260] In certain embodiments, a gradual decrease in viscosity is required at a certain shear (a finite amount of time required to change from high viscosity to low viscosity at a certain shear rate) to provide a sprayable formulation. The present disclosure provides a formulation with reduced viscosity and increasing shear rate to provide an immediate change proportional to the amount of shear that allows for a sprayable formulation, while also allowing the formulation to maintain sufficient viscosity to suspend the composition under low or no shear. In certain embodiments, the formulation has minimal coalescence and does not clump or otherwise settle out of solution when no shear is applied to the formulation. In certain embodiments, when shear is applied to the formulation, it can be sprayed. In certain embodiments, when the formulation hits the skin and there is no shear applied, the formulation thickens again so that it does not run off the surface of the skin and thus produces a uniform coating on the skin.

[0261] In certain embodiments, the composition exhibits lower viscosity, improved processability, and / or improved sprayability compared to existing compositions that contain petrolatum.Sprayable means that the formulation is dispensed through a hand-held spray dispenser by pressing a dispensing button to spray the formulation onto the skin.Any conventional spray dispenser can be used to dispense the skin protectant formulation, including aerosol or pressurized propellant dispensers, motor-driven pump dispensers, or dispensers that use manual spray pump mechanisms.

[0262] Also disclosed are containers configured to dispense a mist or aerosol, the container comprising a reservoir containing the formulation disclosed herein and a nozzle fluidly connected to the reservoir, the nozzle adapted to dispense the formulation as a mist or aerosol. In certain embodiments, the spray bottle comprises a pump that draws liquid (i.e., the formulation) from the reservoir up a siphon tube and through the nozzle. Depending on the spray, the nozzle of the spray bottle may or may not be adjustable to select between a stream or a mist. In certain embodiments, the spray container is a multi-angle spray head / dispenser. In certain embodiments, the disclosed formulations may be further packaged, for example, in a moisture-resistant sealed package that can be repeatedly opened and closed. Alternatively, the package may contain a single-use amount of the disclosed formulation.

[0263] 7. Treatment Method The present disclosure provides a method for treating the skin condition of a subject by topically treating the skin with the composition.Exemplary diseases that can be treated using the topical composition are radiation skin damage, thermal burns, dermatomyofibular fibroma, myositis, burns, diaper rash, itching, acne, sunburn, windburn, heat blisters, cold sores, stinging insects, insect bites, poison ivy, poison oak, poison sumac, dermatitis, other skin conditions, skin discoloration.In certain embodiments, the topical composition is used to treat stretch marks, wrinkles, age spots, scars on face and body, heat or burns, radiation (sun) burns, rosacea, cracked (dry) lips and other skin conditions.

[0264] In certain embodiments, the method involves topical administration of the composition to the affected area of ​​the subject, repeated 1-3 times daily throughout the course of treatment.

[0265] The present disclosure provides methods for strengthening the epidermal barrier to prevent occupationally or environmentally induced, or genetically predisposed skin diseases.

[0266] In most cases, effective results are achieved by topical application of a thin layer onto the affected area or areas where the desired effect is to be achieved. Depending on the condition being addressed, its stage or extent, and whether the application is for therapeutic or preventative reasons, effective results are achieved with application rates ranging from one application every two or three days to four or more applications per day.

[0267] The present disclosure is generally applicable to the treatment of mammalian skin, including, for example, humans, household pets, and livestock and other farm animals.

[0268] 8. Conditions that may be treated by the compositions of the present disclosure The disclosed compositions are successful in treating and preventing diseases and disorders of the skin and mucous membranes that cause a breakdown or dysfunction of the epidermal barrier. As a result, these formulations can be effectively applied to any of the following conditions and skin conditions: Aging, wrinkles, photodamage, stretch marks, scars, liver spots, sunburn, heat or scald, ice burns and frostbite. In one embodiment, the composition may be used to treat bed sores.

[0269] Important causes of morbidity and mortality in premature infants (<33 weeks gestational age) are fluid and electrolyte abnormalities, hypothermia, and infection of the skin, the portal of entry. The development of mature barrier function coincides with the deposition of appropriate amounts of the three major epidermal lipids in appropriate proportions.

[0270] Eczematous dermatitis is a group of inflammatory hyperproliferative skin diseases characterized by poorly demarcated, scaly, itchy or tender patches that may involve widely spread areas of the body. Two of the most common types are atopic dermatitis and seborrheic dermatitis. Both have a genetic predisposition and show abnormalities in stratum corneum lipids and barrier function even in clinically uninvolved skin. The other major eczematous dermatitis results from environmental or occupational insults of solvents, chemicals, detergents, hot water, low ambient humidity, ultraviolet light or X-rays. These diseases include allergic or irritant contact dermatitis, fissure eczema, photoallergic, phototoxic, or phytophotodermatitis, radiation, and stasis dermatitis. Eczema begins as dehydrated or dry skin that reaches such severity that complete destruction of the epidermal barrier occurs, resulting in inflammation and hyperproliferation. The primary treatment for eczematous dermatitis includes topical corticosteroids and systemic antihistamines, with or without antibiotics. Unfortunately, the skin remains overly sensitive for several months after the lesions have apparently resolved clinically, resulting in rapid recovery of the lesions and significantly less environmental insults.Therefore, there is a great need for effective therapeutic formulations that normalize the barrier of both clinically uninvolved and involved skin to prevent disease progression and / or limit the extent of disease.

[0271] Ulcers and erosions result from trauma or ischemia of the skin or mucous membranes. These injuries include chemical or thermal burns, and damage to blood vessels, such as in venous, arterial, embolic or diabetic ulcers. The lesions are not only painful, but also form an entrance for pathogenic microorganisms. Current treatment consists primarily of antibiotics, occlusive dressings, and vascular compression bandages.

[0272] Ichthyoses are a common, incurable, disfiguring group of rare genetic disorders characterized by abnormal epidermal keratinization disorders with or without associated abnormal barrier function and epidermal hyperproliferation. Palliative treatment of these disorders consists of systemic and topical retinoids, as well as topical alpha-hydroxy and salicylic acids. These modalities can produce significant local irritation, and both systemic retinoids and topical salicylic acid carry a significant risk of severe systemic toxicity.

[0273] Epidermolysis bullosa is a group of rare genetic disorders resulting from a lack or defect in epidermal / dermal cohesion. Cutaneous trauma to normal skin with normal daily activities results in complete or partial loss of the epidermis, resulting in blisters, erosions, and ulcers. The only therapy for one type is diphenylhydantoin and / or systemic retinoids. Both treatments produce a significant number of severe systemic side effects with chronic use.

[0274] Psoriasis is a markedly hyperproliferative inflammatory papular-scaling disease characterized by well-circumscribed, scaly plaques that are most frequently located on areas of the body subject to trauma, specifically the knees, elbows, hands, feet, and scalp. Nearly all currently available topical and systemic therapies carry significant risks of systemic and / or cutaneous toxicity. Furthermore, these treatments are generally followed by rapid rebound of the disease when they are discontinued. None of these treatments repair the barrier, and some actually worsen it. Current medications include retinoids, corticosteroids, sulfones, antineoplastic agents, anthralin, tar, psoralens, and ultraviolet A or B light. Recently, it has been reported that long-term remission was achieved in 60% of lesions treated with weekly application of occlusive tape for 10 weeks. This modality artificially restores epidermal barrier function to some degree.

[0275] The skin changes of intrinsic aging and photoaging (dermatophotosis) result from environmental disruption combined with intrinsic changes that result in atrophy, fragility, inelasticity, reduced cell cohesion, hypoproliferation, and delayed healing after injury to the barrier. Stratum corneum lipids show a depletion of ceramides and non-polar lipid species along with a relative increase in cholesterol. Current treatment consists of topical application of retinoids or alpha-hydroxy acids, both of which often produce irritation, especially in the elderly.

[0276] In certain embodiments, the disclosed compositions are used to prevent or treat dry skin, rashes, diaper rash, relief of irritation and itching, chapped lips, poison ivy, oak and sumac, sunburn, windburn, chilblains, etc. In certain embodiments, the disclosed compositions are used as cough suppressants, wound healing, skin healing, cosmetics and beauty products, baby care products, lip balms, and sunscreens.

[0277] A limiting factor in occupational or athletic performance, even for the occasional recreational athlete, is friction blistering of the skin due to mechanical shear forces. Prevention by application of layered clothing or synthetic films is the only somewhat useful treatment currently available.

[0278] The main limiting factor for topical corticosteroid use, especially in younger and older adults, is skin atrophy, which predisposes to infection and slows the rate of healing. Topical retinoids and alpha-hydroxy acids may partially reverse atrophy, but the irritant potential of these agents is significantly increased.

[0279] There are many known or potential therapeutic compounds whose usefulness is hindered or impaired due to skin irritation or barrier disruption. Formulations containing these compounds incorporated with the lipids of the present disclosure expand the therapeutic armamentarium potentially available to the physician.

[0280] It is known that epidermal barrier integrity is the main factor that regulates epidermal DNA synthesis.It is also known that maintaining normal epidermal barrier inhibits epidermal hyperproliferation.Therefore, the discovery of the present disclosure provides treatment for hyperproliferative skin diseases, the prominent examples of which are papular scaly and eczema diseases.

[0281] In some embodiments, the benefits of the treatment of the present disclosure include other areas of the subject that are treated beyond the skin. In some embodiments, the composition of the present disclosure treats the respiratory system of the subject. Common respiratory disorders and diseases that can be treated include chronic obstructive pulmonary disease, asthma, bronchitis, dyspnea, occupational lung disease, pulmonary hypertension. The composition of the present invention can also treat symptoms related to tobacco smoke irritation, air pollution, occupational chemicals and dust, and the effects of infection in the lower and upper respiratory systems. In some embodiments, the composition can also treat synovial infusion, edema and inflammation in joints, including but not limited to arthritis.

[0282] 9. Manufacturing method of the formulation All compounding, filling and storage procedures follow cGMP requirements. All equipment and utensils that come into contact with the individual ingredients are cleaned, sanitized and dried before use. All ingredients are stored in a clean, dry, temperature controlled area between 15°C-25°C. Ingredients are set out in the main mixing area. They are approved for use, weighed, measured and placed into separate, clean, properly identified and labeled, appropriately sized, tared containers.

[0283] Step 1: Into a main reaction vessel equipped with a propeller mixer, Snow White Petrolatum USP was added. The power and temperature of the main reaction vessel were controlled with a variable speed control. Snow White Petrolatum USP was mixed at high speed and heated to 50°C-55°C and maintained at this temperature.

[0284] Step 2: In a separate vessel, additional components of the formulation were mixed and heated to 85°C-90°C until homogeneous. After the additional components were melted and thoroughly mixed, the mixture was slowly added to the main reaction vessel from Step 1 and mixed until homogeneous. The temperature was maintained at 50°C-55°C.

[0285] Step 3: In a separate vessel, additional components of the formulation were mixed until uniform and maintained at 50° C.-55° C. The mixture was then slowly added to the main reaction vessel from step 1 and mixed until uniform. The mixture in the main reaction vessel was then removed from the heat and homogenized until uniformly dispersed.

[0286] Step 4: In a separate vessel, additional components of the formulation were mixed until uniform and added to the main reaction vessel from Step 1 and mixed until uniform. This process was repeated until all ingredients were mixed.

[0287] Step 5: Continue mixing the mixture in the main reaction vessel and cool the mixture to 35° C. A sample of the mixture was then tested and approved. EXAMPLES

[0288] The following examples are illustrative. Modifications will be apparent to and can be readily made by those skilled in the art without departing from the spirit and scope of the present disclosure. The scope of the appended claims is not limited to these examples.

[0289] Example 1 - Skin Protectant Spray

[0290] [Table 1]

[0291] Example 2 - Skin Protectant Spray

[0292] [Table 2]

[0293] Example 3 - Skin Protectant Spray

[0294] [Table 3]

[0295] Example 4 - Skin Protectant Spray

[0296] [Table 4]

[0297] Example 5 - Skin Protectant Spray

[0298] [Table 5]

[0299] In another example, the formulation contains 15% ZnO; 40% petrolatum, and coconut alkane and coco-caprylate / caprate are replaced with 45% isohexadecane.

[0300] Example 6 - Skin Protectant Spray

[0301] [Table 6]

[0302] In another example, the formulation contains 15% ZnO; 40% petrolatum, and coconut alkane and coco-caprylate / caprate are replaced with 45% isohexadecane.

[0303] Example 7 - Skin Protectant Spray

[0304] [Table 7]

[0305] Example 8 - Skin Protectant Spray

[0306] [Table 8]

[0307] Example 9 - Skin Protectant Spray

[0308] [Table 9]

[0309] Example 10 - Skin Protectant Spray

[0310] [Table 10]

[0311] Example 11 - Radiant Spray

[0312] [Table 11]

[0313] Example 12 - Vapor Spray

[0314] [Table 12]

[0315] Example 13 - Method of making formulations Each ingredient was weighed, measured and placed into separate, clean, properly identified and appropriately sized tared containers.

[0316] Step 1: Into a main reaction vessel equipped with a propeller mixer, Snow White Petrolatum USP was added. The power and temperature of the main reaction vessel were controlled with a variable speed control. Snow White Petrolatum USP was mixed at high speed and heated to 50°C-55°C and maintained at this temperature.

[0317] Step 2: In a separate vessel, Vegesil and Ceramide were mixed and heated to 85°C-90°C until homogenous. After the Vegesil and Ceramide were melted and well mixed, the mixture was slowly added to the main reaction vessel from Step 1 and mixed until homogenous. The temperature was maintained at 50°C-55°C.

[0318] Step 3: In a separate vessel, L22 and Natpure Xfine Potato were mixed until uniform and maintained at 50° C.-55° C. The mixture was then slowly added to the main reaction vessel from step 1 and mixed until uniform. The mixture in the main reaction vessel was then removed from the heat and homogenized until the Natpure Xfine Potato SP313 was uniformly dispersed.

[0319] Step 4: Continue mixing the mixture in the main reaction vessel and cool the mixture to 35° C. A sample of the mixture was then tested and approved.

[0320] Exemplary products, systems and methods are described in the following sections: 1. A skin barrier protection delivery system comprising: (i) a mixture of coconut alkanes in a concentration range of 30-70% by weight and coco-caprylate / caprate in a concentration range of 3-7% by weight; and (ii) containing petrolatum present in a concentration of at least 30% by weight; A skin barrier protection delivery system, wherein the delivery system is sprayable. 2. The skin barrier protection delivery system according to item 1, wherein the mixture of coconut alkane and coco-caprylate / caprate is present in a concentration range of 30% to 65% by weight. 3. The skin barrier protection delivery system according to item 1, wherein the mixture of coconut alkane and coco-caprylate / caprate is present in a concentration of up to 70% by weight. 4. The skin barrier protection delivery system of item 1, wherein the petrolatum is present in a concentration of about 40%. 5. The skin barrier protection delivery system of item 1, wherein the petrolatum is present in a concentration of about 50%. 6. The skin barrier protection delivery system of claim 1, further comprising at least one of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols and / or phospholipids. 7. The skin barrier protection delivery system according to item 6, comprising at least two of ceramides, triglycerides, phytosterols, phytosterol esters, terpenes, plant-based esters or waxes, tocopherols and / or phospholipids. 8. The skin barrier protection delivery system according to item 6, comprising at least three of ceramides, triglycerides, phytosterols, phytosterol esters, isohexadecane, terpenes, plant-based esters or waxes, tocopherols and / or phospholipids. 9. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the plant-based ester or wax is selected from the group consisting of jojoba oil, jojoba esters, candelilla wax, carnauba wax, rice bran wax and sunflower wax. 10. The skin barrier protection delivery system according to item 9, wherein the plant-based ester or wax comprises jojoba esters. 11. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the terpene is selected from the group consisting of triterpenes, hemiterpenes, monoterpenes, sesquiterpenes, diterpenes, sesterterpenes and tetraterpenes. 12. The skin barrier protection delivery system according to item 10, wherein the terpene is a triterpene. 13. The skin barrier protection delivery system according to item 12, wherein the triterpene is squalene. 14. The skin barrier protection delivery system according to any one of items 4 to 8, wherein the phytosterol ester comprises an ester derived from a seed oil or a nut oil. 15. The skin barrier protection delivery system according to item 14, wherein the seed or nut oil is selected from the group consisting of macadamia oil, almond oil, avocado oil, canola oil, coconut oil, corn oil, cottonseed oil, grapeseed oil, hazelnut oil, palm oil, peanut oil, pine seed oil, pecan oil, pumpkin seed oil, safflower oil, sesame oil, soybean oil, sunflower oil, and walnut oil. 16. The skin barrier protection delivery system according to item 15, wherein the phytosterol ester is phytosteryl macadamiate. 17. The skin barrier protection delivery system according to item 1, comprising ceramides, triglycerides, phytosterols, phytosterol macadamiate, squalene, jojoba esters, and tocopherol. 18. The skin barrier protection delivery system according to item 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglyceride, and C12-18 acid triglyceride. 19. The skin barrier protection delivery system according to any one of items 1 to 18, further comprising at least one of a polysaccharide, a gum, a buffer, and a root plant extract. 20. The skin barrier protection delivery system according to item 19, wherein the polysaccharide is selected from the group consisting of maltodextrin, cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, starch, hydrolyzed starch, partially hydrolyzed starch, xylan, inulin, cellobiose, scleroglucan, chitosan, ulvan, fucoidan, alginate, pectin, heparin, hyaluronic acid, and mixtures thereof. 21. The skin barrier protection system according to item 19 or 20, wherein the polysaccharide is maltodextrin. 22. The skin barrier protection delivery system according to item 19, wherein the gum is selected from the group consisting of guar gum, xanthan gum, pullulan gum, agar-agar gum, carrageenan gum, gellan gum, gum arabic, and tragacanth gum. 23. The skin barrier protection system according to item 19, wherein the gum is Acacia Senegal gum. 24. The skin barrier protection delivery system according to item 19, wherein the root plant extract is derived from a root plant selected from the group consisting of sweet potato, potato, beet, carrot, parsnip, horseradish and radish. 25. The skin barrier protection delivery system according to item 24, wherein the root plant extract is sweet potato (Ipomoea Batatas) root extract. 26. The skin barrier protection delivery system according to item 19, wherein the acid is citric acid. 27. The skin barrier protection delivery system according to item 19, comprising at least one of sweet potato (Ipomoea Batatas) root extract, citric acid, gum arabic (Acacia Senegal), and maltodextrin. 28. The skin barrier protection delivery system according to item 19, comprising sweet potato (Ipomoea Batatas) root extract, citric acid, gum arabic (Acacia Senegal), and maltodextrin. 29. The skin barrier protection delivery system according to item 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato (Ipomoea Batatas) root extract, gum arabic (Acacia Senegal), citric acid, and maltodextrin. 30. The skin barrier protection delivery system according to item 1, wherein the ratio of the mixture of coconut alkane and / or coco-caprylate / caprate to petrolatum is about 1:1. 31. (i) at least 30% by weight petrolatum; (ii) coconut alkanes in the range of 30-70% by weight; (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NPs in the range of 0.01–0.1 wt %; (v) ceramide AP in the range of 0.01 to 0.1 wt %; (vi) jojoba esters in the range of 0.1 to 1.5% by weight; (vii) squalene in the range of 0.1 to 1% by weight; (viii) phytosteryl macadamiate in the range of 0.01 to 0.1% by weight; (ix) phytosterols in the range of 0.005 to 0.1% by weight; (x) tocopherol in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5-5% by weight; (xii) C12-18 acid triglycerides in the range of 0.1-1 wt.%; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) containing 0.001 to 0.1% by weight of maltodextrin; 2. The skin barrier protection delivery system according to item 1, wherein the delivery system is a sprayable formulation. 32. (i) 50% by weight petrolatum; (ii) 42-43 wt.% coconut alkanes; (iii) 4-5% by weight of coco-caprylate / caprate; (iv) 0.05 wt % ceramide NPs; (v) 0.05 wt % ceramide AP; (vi) 0.75% by weight of jojoba esters; (vii) 0.3 to 0.4% by weight of squalene; (viii) 0.05 to 0.06% by weight of phytosteryl macadamiate; (ix) 0.01 to 0.02% by weight of phytosterols; (x) 0.0045% by weight of tocopherol; (xi) 1-2% by weight of C18-36 acid triglyceride; (xii) 0.4 to 0.5% by weight of a C12-18 acid triglyceride; (xiii) 0.03 to 0.04 wt.% sweet potato (ipomoea batatas) root extract; (xiv) 0.003 to 0.004% by weight of citric acid; (xv) 0.03 to 0.04% by weight of gum arabic (Acacia Senegal); and (xvi) 0.03 to 0.04% by weight of maltodextrin 32. The skin barrier protection delivery system according to item 31, comprising: 33. The skin barrier protection delivery system according to any one of items 1 to 32, further comprising zinc oxide. 34. A skin barrier protection delivery system comprising: (i) 25-60% by weight of petrolatum; (ii) 10 to 25 weight percent zinc oxide (ZnO); and (iii) 30 to 60% by weight of isohexadecane A skin barrier protection delivery system comprising: 35. A skin barrier protection delivery system comprising: (i) 40% by weight of petrolatum; (ii) 15 wt. % zinc oxide (ZnO); and (iii) 45% by weight of isohexadecane A skin barrier protection delivery system comprising: 36. The skin barrier protection delivery system according to any one of items 1 to 35, having a viscosity of about 500 cps to about 10,000 cps. 37. The skin barrier protection delivery system according to any one of items 1 to 36, having a viscosity of about 1,000 cps to about 5000 cps. 38. The skin barrier protection delivery system according to any one of items 1 to 37, further comprising an active ingredient. 39. The skin barrier protection delivery system according to item 35, wherein the active ingredient is present in an amount of about 0.0001% by weight to about 35% by weight. 40. The active ingredient is an antifungal agent, an antibacterial agent, an antiviral agent, an antiacne agent, an anti-aging agent, an antipruritic agent, a UV absorber, a sunscreen, a skin pigment regulator, a skin whitening agent, a skin darkening agent, a hair growth promoter, a hair growth inhibitor, an antidandruff agent, an antiseborrheic agent, an antipsoriasis agent, a depilatory agent, an exfoliant, a wound healing agent, an anti-inflammatory agent, a blood microcirculation improving agent, a sebum regulator, a hormone, an immunomodulator, a plant extract, a moisturizer, a skin softener, an astringent, an antiperspirant, a vitamin, a retinoid, a cleansing agent, a sensate, a discoloring agent, an antibiotic, an anti-irritant, an anesthetic, an analgesic, a steroid, a tissue healing agent, a tissue regenerating agent, 37. The skin barrier protection delivery system according to item 35 or 36, wherein the active ingredient is selected from the group consisting of bioactive agents, collagen or elastin boosting agents, skin protection agents, agents promoting excess fat reduction or cellulite control or body toning effects, amino acids, peptides, minerals, hydroxy acids, antiemetics, antianginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, antimigraine agents, smoking cessation agents, antidiarrheal agents, antiulcer agents, mood disorder agents, antiobesity agents, erectile dysfunction control agents, antiparkinson agents, MAO inhibitors, sleep disorder agents, antidiabetic agents, and combinations thereof. 41. Hydroquinone, arbutin, hydroquinone derivatives, paper mulberry extract (Broussonetia kazinoke), Mitracarpa extract (Mitracarpus scaber), bearberry extract (Arctostaphylos uva ursi), yellow dock extract (Rumex crispus and Rumex occidentalis), glutathione, white blood cell extract, Aspergillus orizae extract, licorice extract (Glycyrrhiza glabra), rosmarinic acid (Rosmarinus officinalis), tetrahydrocurcumin, green tea extract (Camellia 41. The skin barrier protection delivery system according to any one of items 1 to 40, further comprising a skin lightening agent selected from the group consisting of: Spondias mombin extract, Maprounea guianensis extract, Walteria indica extract, Gouania blanchetiana extract, Cordia schomburgkii extract, Randia armata extract, Hibiscus furcellatus extract, and combinations thereof. 42. Ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperedin (Citrus sinensis), diosmin (Citrus sinensis), mangiferin (Mango, Mangifera indica), mangosteen (Garcinia mangostana), cyanidin (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes patula), lycopene (Lycopersicum esculentum), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (Curcuma longa), rosmarinic acid (Rosmarinus 42. The skin barrier protection delivery system according to any one of items 1 to 41, further comprising an antioxidant selected from the group consisting of St. John's wort (Hypericum perforatum), hypericin (Hypericum perforatum), ellagic acid (Punica granatum), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, pycnogenol (pine bark extract), white tea extract, black tea extract, (Andrographis paniculata), carnosine, niacinamide and emblica extract, and combinations thereof. 43. The skin barrier protection delivery system according to any one of items 1 to 42, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (Kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl anthranilate, avobenzone, lawsone, sulisobenzone, trolamine salicylate, lawsone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof. 44. The skin barrier protection delivery system according to any one of items 1 to 43, further comprising a pharma- ceutically acceptable carrier selected from the group consisting of a water and oil emulsion, a suspension, a colloid, a microemulsion, a clear solution, a suspension of nanoparticles, an emulsion of nanoparticles, or an anhydrous composition. 45. A skin barrier protection delivery system according to any one of items 1 to 44, which does not contain any flammable components. 46. ​​The skin barrier protection delivery system according to item 45, which does not contain flammable solubilizers or alcohol. 47. A pharmaceutical composition comprising a skin barrier protection delivery system according to any one of items 1 to 46. 48. A pharmaceutical composition in the form of a sprayable gel, comprising a skin barrier protection delivery system according to any one of items 1 to 47. 49. A device comprising the pharmaceutical composition according to item 47 or 48. 50. The device according to item 49, which does not contain a propellant or aerosol or bag-on-valve. 51. The device according to item 49 or 50, wherein the device is in the form of a sprayer pump. 52. The device according to item 51, wherein the device is a dip tube sprayer pump. 53. A method for protecting the skin of a subject in need thereof, comprising administering to the skin of the subject a skin barrier protection delivery system according to any one of items 1 to 46, a pharmaceutical composition according to item 47 or 48, or a device according to any one of items 49 to 52. 54. A skin barrier protection delivery system comprising: (i) a mixture of long chain alkanes having a carbon length greater than 10 carbons, the long chain alkanes being present in a concentration range of 30-70% by weight; and (ii) petrolatum being present in a concentration of at least 30% by weight, wherein the delivery system is sprayable. 55. A skin barrier protection delivery system comprising: (i) a mixture of a long chain alkane having a carbon length greater than 10 carbons in a concentration range of 30-70% by weight and an ester of a long chain alcohol in a concentration of 3-7% by weight; and (ii) petrolatum present in a concentration of at least 30% by weight, wherein the delivery system is sprayable. 56. The skin barrier protection delivery system according to item 54 or 55, in the form of a sprayable gel. 57. A skin barrier protection delivery system comprising (a) a mixture of coconut alkane and coco-caprylate / caprate, and (b) petrolatum present in a concentration of at least 30%, the ratio of (a) to (b) being between 7:3 and 1:3. 58. A skin barrier protection delivery system consisting essentially of (a) a mixture of coconut alkane and coco-caprylate / caprate, and (b) petrolatum present in a concentration of at least 30%, wherein the ratio of (a) to (b) is between 7:3 and 1:3. 59. A skin barrier protection delivery system according to any one of items 1 to 58, wherein the ratio of coconut alkane to coco-caprylate / caprate is from about 7:3 to about 1:3. 60. The skin barrier protection delivery system according to any one of items 1 to 59, further comprising at least two of ceramides, phytosterols, squalene, plant-based esters or waxes, and / or phospholipids. 61. An emulsion comprising a skin barrier protection delivery system according to any one of items 1 to 60. 62. A skin barrier protection delivery system according to any one of items 1 to 61, which is sprayable. 63. The skin barrier protection delivery system according to any of items 1 to 62, having a viscosity of about 500 cps to about 10,000 cps. 64. A skin barrier protection delivery system comprising a mixture of coconut alkane and coco-caprylate / caprate at a concentration of at least 30%, wherein the ratio of coconut alkane to coco-caprylate / caprate is between 7:3 and 1:3. 65. A skin barrier protection delivery system consisting essentially of a mixture of coconut alkane and coco-caprylate / caprate, the ratio of coconut alkane to coco-caprylate / caprate being between 7:3 and 1:3. 66. A skin barrier protection delivery system according to any one of items 1 to 65, wherein the ratio of coconut alkane to coco-caprylate / caprate is from about 7:3 to about 1:3. 67. A skin barrier protection delivery system according to any one of items 1 to 66, further comprising at least two of ceramides, phytosterols, squalene, plant-based esters or waxes, and / or phospholipids. 68. An emulsion comprising a skin barrier protection delivery system according to any one of items 1 to 67. 69. A skin barrier protection delivery system according to any one of items 1 to 68, which is sprayable. 70. The skin barrier protection delivery system according to any one of items 1 to 69, having a viscosity of about 500 cps to about 10,000 cps. 71. The skin barrier protection delivery system according to any one of items 1 to 70, further comprising an active ingredient. 72. A skin barrier protection delivery system according to any one of items 1 to 71, wherein the active ingredient is from about 0.0001% by weight to about 95% by weight. 73. The active ingredient is an antifungal agent, an antibacterial agent, an antiviral agent, an antiacne agent, an anti-aging agent, an antipruritic agent, a UV absorber, a sunscreen, a skin pigment regulator, a skin whitening agent, a skin darkening agent, a hair growth promoter, a hair growth inhibitor, an antidandruff agent, an antiseborrheic agent, an antipsoriasis agent, a depilatory agent, an exfoliant, a wound healing agent, an anti-inflammatory agent, a blood microcirculation improver, a sebum regulator, a hormone, an immune regulator, a plant extract, a moisturizer, a skin softener, an astringent, an antiperspirant, a vitamin, a retinoid, a cleansing agent, a sensate, a discoloring agent, an antibiotic, an anti-irritant, an anesthetic, an analgesic, a steroid, a tissue healing agent, or a tissue regenerator. 73. The skin barrier protection delivery system according to any one of items 1 to 72, wherein the active ingredient is selected from the group consisting of collagen or elastin boosting agents, skin protection agents, agents promoting excess fat reduction or cellulite control or body toning effects, amino acids, peptides, minerals, hydroxy acids, antiemetics, antianginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, antimigraine agents, smoking cessation agents, antidiarrheal agents, antiulcer agents, mood disorder agents, antiobesity agents, erectile dysfunction control agents, antiparkinson agents, MAO inhibitors, sleep disorder agents, antidiabetic agents, and combinations thereof. 74. Hydroquinone, arbutin, hydroquinone derivatives, paper mulberry extract (Broussonetia kazinoke), Mitracarpa extract (Mitracarpus scaber), bearberry extract (Arctostaphylos uva ursi), yellow dock extract (Rumex crispus and Rumex occidentalis), glutathione, white blood cell extract, Aspergillus orizae extract, licorice extract (Glycyrrhiza glabra), rosmarinic acid (Rosmarinus officinalis), tetrahydrocurcumin, green tea extract (Camellia 74. The skin barrier protection delivery system according to any one of items 1 to 73, further comprising a skin lightening agent selected from the group consisting of: Pausinystalia yohimbe, Ecklonia cava extract, Niacinamide, Hydroxytetronic acid, Spondias mombin extract, Maprounea guianensis extract, Walteria indica extract, Gouania blanchetiana extract, Cordia schomburgkii extract, Randia armata extract, Hibiscus furcellatus extract, and combinations thereof. 75. Ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperedin (Citrus sinensis), diosmin (Citrus sinensis), mangiferin (Mango, Mangifera indica), mangosteen (Garcinia mangostana), cyanidin (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes patula), lycopene (Lycopersicum esculentum), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (Curcuma longa), rosmarinic acid (Rosmarinus 75. The skin barrier protection delivery system according to any one of items 1 to 74, further comprising an antioxidant selected from the group consisting of St. John's wort (Hypericum perforatum), hypericin (Hypericum perforatum), ellagic acid (Punica granatum), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, pycnogenol (pine bark extract), white tea extract, black tea extract, (Andrographis paniculata), carnosine, niacinamide and emblica extract, and combinations thereof. 76. The skin barrier protection delivery system according to any one of items 1 to 75, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (Kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl anthranilate, avobenzone, lawsone, sulisobenzone, trolamine salicylate, lawsone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof. 77. The skin barrier protection delivery system according to any one of items 1 to 76, which is a formulation selected from the group consisting of a lotion, a cream, a gel, a spray, a thin liquid, a body splash, a mask, a serum, a solid cosmetic stick, a lip balm, a shampoo, a liquid soap, a bar soap, a bath oil, a cologne, a hair conditioner, an ointment, a collodion, an impregnated patch, an impregnated strip or a skin surface implant. 78. The skin barrier protection delivery system according to any one of items 1 to 77, further comprising a pharma- ceutically acceptable carrier selected from the group consisting of water and oil emulsions, suspensions, colloids, microemulsions, clear solutions, suspensions of nanoparticles, emulsions of nanoparticles, and anhydrous compositions. 79. (i) at least 30% by weight of petrolatum; (ii) coconut alkanes in the range of 30-70% by weight; (iii) coco-caprylate / caprate in the range of 3-7% by weight; (iv) ceramide NP in the range of 0.01-0.1% by weight; (v) ceramide AP in the range of 0.01-0.1% by weight; (vi) jojoba esters in the range of 0.1-1.5% by weight; (vii) squalene in the range of 0.1-1% by weight; (viii (x) tocopherol in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglyceride in the range of 0.5 to 5% by weight; (xii) C12-18 acid triglyceride in the range of 0.1 to 1% by weight; (xiii) sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) citric acid in the range of 0.001 to 0.01% by weight; (xv) gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) maltodextrin in the range of 0.001 to 0.1% by weight, wherein the delivery system is a spray formulation. 80. (i) 50% by weight of petrolatum; (ii) 42-43% by weight of coconut alkane; (iii) 4-5% by weight of coco-caprylate / caprate; (iv) 0.05% by weight of ceramide NP; (v) 0.05% by weight of ceramide AP; (vi) 0.75% by weight of jojoba esters; (vii) 0.3-0.4% by weight of squalene; (viii) 0.05- 79. The skin barrier protection delivery system according to any one of items 1 to 79, comprising 0.06% by weight of phytosteryl macadamiate; (ix) 0.01 to 0.02% by weight of phytosterol; (x) 0.0045% by weight of tocopherol; (xi) 1 to 2% by weight of C18-36 acid triglyceride; (xii) 0.4 to 0.5% by weight of C12-18 acid triglyceride; (xiii) 0.03 to 0.04% by weight of sweet potato (ipomoea batatas) root extract; (xiv) 0.003 to 0.004% by weight of citric acid; (xv) 0.03 to 0.04% by weight of Acacia Senegal gum; and (xvi) 0.03 to 0.04% by weight of maltodextrin. 81. The skin barrier protection delivery system according to any one of items 1 to 80, having a viscosity of about 500 cps to about 10,000 cps. 82. The skin barrier protection delivery system according to any one of items 1 to 81, having a viscosity of about 1,000 cps to about 5000 cps. 83. The skin barrier protection delivery system according to any one of items 1 to 82, further comprising an active ingredient. 84. A skin barrier protection delivery system according to any one of items 1 to 83, wherein the active ingredient is from about 0.0001% by weight to about 70% by weight. 85. The active ingredient is an antifungal agent, an antibacterial agent, an antiviral agent, an antiacne agent, an anti-aging agent, an antipruritic agent, a UV absorber, a sunscreen, a skin pigment regulator, a skin whitening agent, a skin darkening agent, a hair growth promoter, a hair growth inhibitor, an antidandruff agent, an antiseborrheic agent, an antipsoriasis agent, a depilatory agent, an exfoliant, a wound healing agent, an anti-inflammatory agent, a blood microcirculation improver, a sebum regulator, a hormone, an immune regulator, a plant extract, a moisturizer, a skin softener, an astringent, an antiperspirant, a vitamin, a retinoid, a cleansing agent, a sensate, a discoloring agent, an antibiotic, an anti-irritant, an anesthetic, an analgesic, a steroid, a tissue healing agent, or a tissue regenerator. 85. The skin barrier protection delivery system according to any one of items 1 to 84, wherein the active ingredient is selected from the group consisting of collagen or elastin boosting agents, skin protection agents, agents promoting excess fat reduction or cellulite control or body toning effects, amino acids, peptides, minerals, hydroxy acids, antiemetics, antianginal agents, bronchodilators, osteoporosis treatment agents, antidepressants, antimigraine agents, smoking cessation agents, antidiarrheal agents, antiulcer agents, mood disorder agents, antiobesity agents, erectile dysfunction control agents, antiparkinson agents, MAO inhibitors, sleep disorder agents, antidiabetic agents, and combinations thereof. 86. Hydroquinone, arbutin, hydroquinone derivatives, paper mulberry extract (Broussonetia kazinoke), Mitracarpa extract (Mitracarpus scaber), bearberry extract (Arctostaphylos uva ursi), yellow dock extract (Rumex crispus and Rumex occidentalis), glutathione, white blood cell extract, Aspergillus orizae extract, licorice extract (Glycyrrhiza glabra), rosmarinic acid (Rosmarinus officinalis), tetrahydrocurcumin, green tea extract (Camellia 86. The skin barrier protection delivery system according to any one of items 1 to 85, further comprising a skin lightening agent selected from the group consisting of: Pausinystalia yohimbe, Ecklonia cava extract, Niacinamide, Hydroxytetronic acid, Spondias mombin extract, Maprounea guianensis extract, Walteria indica extract, Gouania blanchetiana extract, Cordia schomburgkii extract, Randia armata extract, Hibiscus furcellatus extract, and combinations thereof. 87. Ascorbic acid, ascorbic acid derivatives, vitamin E, vitamin E derivatives, tocotrienols, rutin, quercetin, hesperedin (Citrus sinensis), diosmin (Citrus sinensis), mangiferin (Mango, Mangifera indica), mangosteen (Garcinia mangostana), cyanidin (Vaccinium myrtillus), astaxanthin (Haematococcus algae), lutein (Tagetes patula), lycopene (Lycopersicum esculentum), resveratrol (Polygonum cuspidatum), tetrahydrocurcumin (Curcuma longa), rosmarinic acid (Rosmarinus 87. The skin barrier protection delivery system according to any one of items 1 to 86, further comprising an antioxidant selected from the group consisting of St. John's wort (Hypericum perforatum), hypericin (Hypericum perforatum), ellagic acid (Punica granatum), chlorogenic acid (Vaccinium vulgaris), oleuropein (Olea europaea), alpha-lipoic acid, glutathione, andrographolide, grape seed extract, green tea extract, polyphenols, pycnogenol (pine bark extract), white tea extract, black tea extract, (Andrographis paniculata), carnosine, niacinamide and emblica extract, and combinations thereof. 88. The skin barrier protection delivery system according to any one of items 1 to 87, further comprising a UVA / UVB sunscreen selected from the group consisting of titanium dioxide, zinc oxide, galangal extract (Kaempferia galanga), benzophenone-3, benzophenone-4, ethylhexyl methoxycinnamate, homosalate, ethylhexyl salicylate, octocrylene, menthyl anthranilate, avobenzone, lawsone, sulisobenzone, trolamine salicylate, lawsone, glyceryl aminobenzoate, cinoxate, PABA, and combinations thereof. 89. The skin barrier protection delivery system according to any one of items 1 to 88, which is a formulation selected from the group consisting of a lotion, a cream, a gel, a spray, a thin liquid, a body splash, a mask, a serum, a solid cosmetic stick, a lip balm, a shampoo, a liquid soap, a bar soap, a bath oil, a cologne, a hair conditioner, an ointment, a collodion, an impregnated patch, an impregnated strip or a skin surface implant. 90. The skin barrier protection delivery system according to any one of items 1 to 89, further comprising a pharma- ceutically acceptable carrier selected from the group consisting of water and oil emulsions, suspensions, colloids, microemulsions, clear solutions, suspensions of nanoparticles, emulsions of nanoparticles, and anhydrous compositions. 91. A method for making the skin barrier protection delivery system of claim 1, comprising: (a) mixing petrolatum, an ester of a long chain alkane and / or a long chain alcohol in a reactor to make a mixture; (b) heating the mixture until a melt is obtained; and (c) cooling the mixture. 92. A method of making the skin barrier protection delivery system of claim 1, comprising: (a) heating petrolatum in a reactor; (b) adding an ester of a long-chain alkane and a long-chain alcohol to the reactor to produce a mixture; (c) heating the mixture until a melt is obtained; and (d) cooling the mixture.

[0321] The above description of the specific embodiments will fully reveal the general nature of the present disclosure, such that others may easily modify and / or adapt such specific embodiments to various applications without undue experimentation by applying knowledge within the art of the relevant art (including the contents of documents cited and incorporated by reference herein) without departing from the general concept of the present disclosure. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It should be understood that the expressions or terminology in the present specification are for the purpose of explanation and not for limitation, and should be interpreted by those skilled in the art in light of the teaching and guidance presented herein, in combination with the knowledge of those skilled in the art of the relevant art.

[0322] Although various embodiments of the present disclosure have been described above, it should be understood that they are presented by way of example and not by way of limitation. It will be apparent to those skilled in the relevant art that various changes in form and details may be made therein without departing from the spirit and scope of the present disclosure. Thus, the present disclosure should not be limited by any of the above exemplary embodiments, but should be defined only according to the following claims and their equivalents.

[0323] All references cited in this specification are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication or patent or patent application was specifically and individually indicated to be incorporated by reference in its entirety for all purposes.

Claims

1. A skin barrier protection delivery system, (i) A mixture of coconut alkanes in a concentration range of 30–70% by weight and coco-caprylate / caprate in a concentration range of 3–7% by weight, and (ii) comprising petrolatum present at a concentration of at least 30% by weight, A skin barrier protection delivery system in which the delivery system can be sprayed.

2. The skin barrier protection delivery system according to claim 1, comprising ceramide NP, ceramide AP, jojoba esters, squalene, phytosterol, phytosteryl macadamiate, tocopherol, C18-C36 acid triglycerides, C12-18 acid triglycerides, sweet potato (Ipomoea Batatas) root extract, gum of gum arabic (Acacia Senegal), citric acid, and maltodextrin.

3. (i) at least 30% by weight of petrolatum; (ii) Coconut alkanes in the range of 30-70% by weight; (iii) Coco-caprylate / caplate in the range of 3-7% by weight; (iv) Ceramide NP in the range of 0.01 to 0.1% by weight; (v) Ceramide AP in the range of 0.01 to 0.1% by weight; (vi) Jojoba esters in the range of 0.1 to 1.5% by weight; (vii) Squalene in the range of 0.1 to 1% by weight; (viiii) Phytosteryl macadamiate in the range of 0.01 to 0.1% by weight; (ix) Phytosterols in the range of 0.005 to 0.1% by weight; (x) Tocopherol in the range of 0.001 to 0.1% by weight; (xi) C18-36 acid triglycerides in the range of 0.5 to 5% by weight; (xi) C12-18 acid triglycerides in the range of 0.1 to 1% by weight; (xiiii) Sweet potato (ipomoea batatas) root extract in the range of 0.01 to 0.1% by weight; (xiv) Citric acid in the range of 0.001 to 0.01% by weight; (xv) Gum of gum arabic (Acacia Senegal) in the range of 0.001 to 0.1% by weight; and (xvi) Contains maltodextrin in the range of 0.001 to 0.1% by weight, The skin barrier protection delivery system according to claim 1, comprising the delivery system being a sprayable formulation.

4. (i) 50% by weight of petrolatum; (ii) 42-43% by weight of coconut alkanes; (iii) 4-5% by weight of coco-caprylate / caplate; (iv) 0.05 wt% ceramide NP; (v) 0.05 wt% ceramide AP; (vi) 0.75% by weight of jojoba esters; (vii) 0.3 to 0.4% by weight of squalene; (viiii) 0.05–0.06% by weight of phytosteryl macadamiate; (ix) 0.01–0.02% by weight of phytosterols; (x) 0.0045% by weight of tocopherol; (xi) 1-2% by weight of C18-36 acid triglycerides; (xi) 0.4–0.5% by weight of C12–18 acid triglycerides; (xiiii) 0.03–0.04% by weight of sweet potato (Ipomoea batatas) root extract; (xiv) 0.003 to 0.004% by weight of citric acid; (xv) Gum of 0.03–0.04% by weight of gum arabic (Acacia Senegal); and (xvi) The skin barrier protection delivery system according to claim 1, comprising 0.03 to 0.04% by weight of maltodextrin.

5. A skin barrier protection delivery system according to any one of claims 1 to 4, further comprising zinc oxide.

6. A skin barrier protection delivery system according to any one of claims 1 to 5, characterized by being for the protection, prevention or treatment of skin barrier damage in a subject requiring such protection, prevention or treatment, a pharmaceutical composition according to any one of claims 1 to 5, or a device according to any one of claims 1 to 5.