Topical composition with ammonium acryloyldimethyltaurate / VP copolymer

Abstract

The present invention is directed to a composition comprising: (a) at least one oil, (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 3:9 to 8:9, preferably, from 5:9 to 8:9, and more preferably, from 7:9 to 8:9, (c) a thickener, and (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), a beta-hydroxy acid (BHA), a poly-hydroxy acid (PHA), or any salt or any combination thereof.

Description

[0001] TOPICAL COMPOSITION

[0002] Field of the Invention

[0003] The present invention relates to a topical composition, and the present composition can be utilized for a variety of skin care conditions, including keratosis pilaris.

[0004] Background of the Invention

[0005] Keratosis pilaris (KP) is a common genetic condition affecting the hair follicles of the skin, characterized by small bumps resembling gooseflesh (e.g., papules), which may sometimes be itchy, and vary in degrees of redness or inflammation. It typically appears on the outer sides of the upper arms, thighs, face, back, and buttocks. KP occurs when the body produces excess keratin, leading to the formation of raised bumps on the skin, often accompanied by surrounding redness, which on some consumers, can be very noticeable. The surplus keratin surrounds and traps the hair follicles within the pores.

[0006] Treatment options for KP include both chemical exfoliants and physical exfoliants. Chemical exfoliants, such as salicylic acid, lactic acid, glycolic acid, and the like, are known to help increase cell turnover, improve skin texture, and minimize the appearance of pores. Yet for a subset of consumers, especially those with sensitive skin, the chemical exfoliants can cause skin irritation. Physical exfoliants may be gentler but also can irritate or damage skin if not used properly. Accordingly, for some consumers, treatment with these conventional exfoliants can be harsh, and leaving a need other suitable compositions to alleviate some of the known characteristics of KP. Therefore, a need exists for a topical product that effectively reduces KP symptoms while being suitable for sensitive skin.

[0007] Surprisingly and unexpectedly, the inventors of the present invention have developed a topical composition that uses chemical exfoliants but is suitable for sensitive skin, still leaves skin moisturized and not dry, improves the overall health of the skin barrier, and can be delivered in a lightweight and quick absorbing formulation that can help alleviate the appearance of KP while not resulting in the drawbacks associated with using some chemical exfoliants. In addition, the present invention can also deliver additional skin benefit agents for additionalbenefits including anti-ageing, including the reduction of fine lines and wrinkles and age spots, as well as an overall improved and even skin tone and glow. These and other features and advantages of the present invention will be explained and will become apparent to one skilled in the art through the summary of the invention that follows.

[0008] Summary of the Invention

[0009] In a first aspect, the present invention is directed to a composition comprising: (a) at least one oil wherein the at least one oil is a hydrocarbon oil, an emollient oil, a triglyceride, a silicone oil, or any combination thereof, and optionally includes at least one oil-soluble sunscreen; (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15; (c) from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably, from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein at least 65%, preferably, from 65 to 100 wt%, more preferably, from 80 to 100 wt%, and even more preferably, from 95 to 100 wt% of the thickener comprises a first acryloyldimethyltaurate polymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer, a natural or synthetic gum, a cellulosic, or a combination thereof, preferably, ammonium acryloyldimethyltaurate / VP copolymer; and (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), a beta-hydroxy acid (BHA), a poly-hydroxy acid (PHA), or any salt, or any combination thereof.

[0010] In a second aspect, the present invention is directed to methods of applying the compositions disclosed herein for treatment of keratosis pilaris.

[0011] In another aspect, the present invention is directed to use of the composition disclosed herein for treating keratosis pilaris.

[0012] All other aspects of the present invention will more readily become apparent from the description and examples which follow.Detailed Description of the Invention

[0013] Except in the examples, or where otherwise explicitly indicated, all numbers in this description indicating amounts of material or conditions of reaction, physical properties of materials and / or use may optionally be understood as modified by the word “about”.

[0014] All amounts are by weight of any of the emulsions or components thereof, unless otherwise specified. It should be noted that in specifying any ranges of values, any particular upper value can be associated with any particular lower value.

[0015] For the avoidance of doubt, the term "comprising" is meant not to be limiting to any stated elements but rather to encompass non-specified elements of major or minor functional importance. Therefore, the listed steps, elements or options need not be exhaustive. Whenever the words "including" or "having" are used, these terms are meant to be equivalent to "comprising" as defined above.

[0016] The disclosure, as found herein, is to be considered to cover all embodiments as found in the claims as being multiply dependent upon each other irrespective of the fact that claims may be found without multiple dependency or redundancy.

[0017] “Skin”, as used herein, includes skin on the face, neck, chest, back, arms (including underarms), axilla, buttocks, hands, legs and scalp.

[0018] “Sensitive skin”, as used herein, include sensations such as stinging, tingling, itching or pruritus, burning, heating, discomfort, tautness, etc., in response to various factors such as the environment (e.g., pollutants), emotions, foods, wind, friction, shaving, soap, surfactants, hard water having a high calcium concentration, temperature variations, or wool, or the like.

[0019] “Skin care benefit”, as used herein, refers to a cosmetic improvement in a facial or body characteristic after topical application, for example, even skin tone such as skin brightening and / or glow, skin texture such as reduction in wrinkles, fine lines and / or age spots, strengthen skin barrier, dry skin, improve moisturization, anti-acne or the like. A “skin care benefit agent” can be used to address these skin care benefits.

[0020] “Skin-feel properties”, as used herein, refers to the sensation of applying the emulsion to the skin, such as glides easily across the skin (e.g., highly spreadable and lightweight feel), does not feel greasy or tacky but instead a silky feel and is quickly absorbed into the skin.“Stable”, as used herein, means no visual separation after 12 weeks, or from 12 to 16 weeks, or from 12 to 14 weeks, after testing at 5°C, 25°C, 37°C, 45°C, and 50°C.

[0021] As used herein, “substantially free of” refers to having less than 3 wt%, or less than 1 wt%, or less than 0.5 wt%, or less than 0.1 wt%, or less than 0.01 wt% of the compound, by weight of the emulsion, In one aspect, “substantially free of” refers to having from 0.00001 wt% to 1.5 wt%, or 0.00001 wt% to 1 wt%, or 0.00001 wt% to 0.5 wt% of the compound, by weight of the emulsion, preferably free of such compound (e.g., 0.0 wt%).

[0022] In one aspect, the present invention is directed to a composition comprising: (a) at least one oil wherein the at least one oil is a hydrocarbon oil, an emollient oil, a triglyceride, a silicone oil, or any combination thereof, and optionally includes at least one an oil-soluble sunscreen; (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15; (c) from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably, from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein at least 65%, preferably, from 65 to 100 wt%, more preferably, from 80 to 100 wt%, and even more preferably, from 95 to 100 wt% of the thickener comprises a first acryloyldimethyltaurate polymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer, a natural or synthetic gum, a cellulosic, or a combination thereof, preferably, ammonium acryloyldimethyltaurate / VP copolymer; and (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), a beta-hydroxy acid (BHA), a poly-hydroxy acid (PHA), or any salt, or any combination thereof.

[0023] The present composition can be an emulsion, preferably, and oil-in-water (or O / W) emulsion, comprising an oil phase is dispersed in an aqueous phase.

[0024] Oil Phase

[0025] The composition disclosed herein includes at least one oil such as a hydrocarbon oil, an emollient oil, a triglyceride, a silicone oil, or any combination thereof, and optionally includes at least one oil-soluble sunscreen. In one aspect, the composition comprises from 1 to 15 wt%, or from 1 to 10 wt%, or from 1 to 8 wt%, or from 1 to 5 wt%, or from 2.5 to 10 wt%, or from 2.5 to7.5 wt%, or from 2.5 to 5 wt%, of the at least one oil and optional oil-soluble sunscreen, based on the total weight of the composition.

[0026] Oil(s)

[0027] In one aspect, the oil is a hydrocarbon oil, preferably, a linear or branched, saturated or unsaturated, hydrocarbon oil comprising from 8 to 34 carbons, for example, liquid paraffins and / or alkanes such as C9-C15 paraffins and / or alkanes, including a C9-C12 alkane, a C10-13 alkane, a C13-C15 alkane, C11-C13 paraffins and / or alkanes, liquid isoparaffins and / or isoalkanes such as C9-C15 isoparaffins and / or isoalkanes, preferably, C11-C13 isoparaffins and / or isoalkanes, isododecane, isohexadecane, a C12-C17 alkane, a C15-19 alkane, a C14-C22 alkane, a C18-21 alkane, squalane, squalene, or any combination thereof. Other suitable oils include hydrocarbon oils such as petrolatum and mineral oil. In one aspect, when included, the total amount of hydrocarbon oil is from 0.01 to 5 wt%, or from 0.1 to 4 wt%, or from 0.1 to 2 wt%, or from 0.5 to 3 wt%, or from 0.5 to 2 wt%, or from 0.5 to 1.5 wt%, or from 0.75 to 1.25 wt%, based on the total weight of the composition.

[0028] Additional suitable oils include emollient oils including (a) fatty acids having 6 to 30 carbons like hexanoic, heptanoic, octanoic, nonanoic, lauric, myristic, palmitic, stearic, behenic, oleic, linoleic, linolenic, isostearic acid, or any combination thereof, (b) alkenyl or alkyl esters of fatty acids having 6 to 30 carbon atoms like isopropyl palmitate, isopropyl isostearate, isononyl isonanonoate, oleyl myristate, isopropyl myristate, oleyl stearate, and oleyl oleate, as well as others esters such as cetyl lactate and myristyl lactate; (c) ether-esters such as fatty acid esters of ethoxylated fatty alcohols; (d) ethers including C6 to C30 ethers including dicaprylyl ether, and sterol esters, of which soya sterol and cholesterol fatty acid esters are examples thereof, as well as alkoxylated ethers and diethers such as PPG-10 butyl ether, PPG-11 butyl ether, PPG-12 butyl ether, PPG-13 butyl ether, PPG-14 butyl ether, PPG-15 butyl ether, PPG-16 butyl ether, PPG-17 butyl ether, PPG-18 butyl ether, PPG-19 butyl ether, PPG-20 butyl ether, PPG-22 butyl ether, PPG-24 butyl ether, PPG-30 butyl ether, PPG-11 stearyl ether, PPG-15 stearyl ether, PPG-10 oleyl ether, PPG-7 lauryl ether, PPG-30 isocetyl ether, PPG-10 glyceryl ether, PPG-15 glyceryl ether, PPG-10 butyleneglycol ether, PPG-15 butylene glycol ether, PPG-27 glyceryl ether, PPG-30 cetyl ether, PPG-28 cetyl ether, PPG-10 cetyl ether, PPG-10 hexylene glycol ether, PPG-15 hexylene glycol ether, PPG-101 ,2,6-hexanetriol ether, PPG-151 ,2,6-hexanetriol ether, PPG-1 0 1 ,4-butanediol diether, PPG-12 1,4-butanediol diether, PPG-14 1 ,4-butanediol diether, PPG-2 butanediol diether, PPG-101,6-hexanediol diether, PPG-12 1 ,6-hexanediol diether, PPG-14 hexanediol diether, PPG-20 hexanediol diether, or any combination thereof. In one aspect, the oil is a fatty acid, preferably, stearic acid, palmitic acid, or a combination thereof. In one aspect, the oil comprises at least one fatty acid and an ether, preferably, such that the fatty acid is stearic acid, palmitic acid, or a combination thereof, and the ether is dicaprylyl ether. In one aspect, when included, the total amount of emollient oil is from 0.01 to 5 wt%, or from 0.1 to 4 wt%, or from 0.1 to 3 wt%, or from 0.5 to 3 wt%, or from 0.5 to 2 wt%, or from 0.5 to 1.75 wt%, or from 0.75 to 2 wt%, or from 1 to 2 wt%, based on the total weight of the composition.

[0029] Additional suitable oils include triglycerides including but not limited to caprylic / capric triglyceride, corn oil, cotton seed oil, olive oil, palm kernel oil, rape seed oil, linseed oil, flaxseed oil, safflower seed oil, evening primrose oil, soybean oil, sunflower seed oil, avocado oil, sesame seed oil, coconut oil, arachis oil, castor oil, or any combination thereof. In one aspect, when included, the total amount of triglycerides is from 0.01 to 5 wt%, or from 0.1 to 4 wt%, or from 0.1 to 2 wt%, or from 0.5 to 3 wt%, or from 0.5 to 2 wt%, or from 0.5 to 1.5 wt%, based on the total weight of the composition.

[0030] Silicone materials of liquid, solid, or semi-solid consistency at room temperature may optionally be included in the emulsion described herein. Liquid silicones include silicone oils which may be divided into the volatile and nonvolatile variety. The term "volatile" as used herein refers to those materials which have a measurable vapor pressure at ambient temperature. Volatile silicone oils are preferably chosen from cyclic (cyclomethicone) or linear polydimethylsiloxanes containing from 3 to 9, preferably, from 4 to 5, silicon atoms, preferably, cyclotetrasiloxane (D4), cyclopentasiloxane (D5), cyclohexasiloxane (D6), hexamethyldisiloxane, and / or mixtures thereof. Nonvolatile silicones include nonvolatile silicone oils such as polyalkyl siloxanes, polyalkylaryl siloxanes and polyether siloxane copolymers, including dimethicones and caprylyl methicone, and silicone waxes such as dimethicone copolyol laurate. Solid silicones may include polymethylsilsesquioxane (PSQ). In one aspect, when included, the total amount of silicone materials is from 0.01 to 5 wt%, or from 0.1 to 4 wt%, or from 0.1 to 2 wt%, or from 0.5 to 3 wt%, or from 0.5 to 2 wt%, or from 0.5 to 1.5 wt%, or from 0.75 to 1.25 wt%, based on the total weight of the composition. In one aspect, the silicone material is a volatile silicone oil, preferably, cyclopentasiloxane. In one aspect the emulsion is substantially free of volatile silicones. In one aspect, the emulsion is substantially free of D5. In one aspect, the emulsion issubstantially free of solid silicones. In one aspect, the composition is substantially free of silicone materials, including silicone oils.

[0031] In one aspect, oil-soluble sunscreen(s) can be included with the oils described herein. Suitable oil-soluble sunscreens include but are not limited to octyl salicylate, 3,3,5-trimethylcyclohexyl 2-hydroxybenzoate (“homosalate”), ethylhexyl salicylate (“octisalate”), ethylhexyl methoxycinnamate (“octinoxate”), 2-ethylhexyl 2-cyano-3,3-diphenylprop-2-enoate (“octocrylene”), or 2-ethylhexyl-4-methoxycinnamate (also known as octyl methoxycinnamate or “OMC”), 4-t-butyl-4’-methoxydibenzoylmethane (or butyl methoxydibenzoylmethane or “avobenzone”), 2-methyldibenzoylmethane, 4-methyl-dibenzoyl-ethane, 4-isopropyldibenzoyl-methane, 4-tert-butyldibenzoylmethane, 2,4-dimethyldibenzoylmethane, 2,5-dimethyldibenzoylmethane, 4,4’-diisopropyldibenzoylmethane, 2-methyl-5-isopropyl-4’-methoxy-dibenzoylmethane, 2-methyl-5-tert-butyl-4’-methoxy-dibenzoylmethane, 2,4-dimethyl-4’-methoxydibenzoylmethane, 2,6-dimehyl-4-tert-butyl-4’methoxy-dibenzoylmethane, diethylaminohydroxybenzoyl hexyl benzoate, or methyl anthranilate. Another suitable oil-soluble sunscreen includes Bemotrizinol (BEMT). Additional oil-soluble sunscreens include those commercially available from BASF corporation: llvinul T-150 (Ethylhexyl triazone; a IIV-B sunscreen oil), llvinul A Plus (Diethylamino hydroxy benzoyl hexyl benzoate; a UV-A sunscreen oil), Tinosorb S (bis-ethylhexyloxyphenol methoxyphenyl triazine; a UV-A and UV-B sunscreen oil), Tinosorb M (methylene bisbenzotriazolyl tetramethylbutylphenol; a UV-A and UV-B sunscreen oil), Mexoryl XL, and / or Mexoryl 400. Preferably, the sunscreen is 3,3,5-trimethylcyclohexyl 2-hydroxybenzoate (“homosalate”), ethylhexyl salicylate (“octisalate”), ethylhexyl methoxycinnamate (“octinoxate”), 2-ethylhexyl 2-cyano-3,3-diphenylprop-2-enoate (“octocrylene”), 4-t-butyl-4’-methoxydibenzoylmethane (“avobenzone”), or any combinations thereof, more preferably, ethylhexyl methoxycinnamate (“octinoxate”), or any combination thereof. When included, the composition comprises from 0.001 to 8 wt%, or from 0.001 to 5 wt%, or 0.001 to 3 wt%, or 0.001 to 1 wt%, or 0.001 to 0.5 wt%, or 0.001 to 0.1 wt%, or 0.01 to 5 wt%, or 0.01 to 4 wt%, or 0.01 to 3 wt%, or 0.01 to 2 wt%, or 0.01 to 1 wt%, or 0.01 to 0.5 wt%, or 0.1 to 5 wt%, or 0.1 to 4 wt%, or 0.01 to 3 wt%, or 0.1 to 2 wt%, or 0.01 to 1 wt%, or 0.1% to 0.5 wt%, by weight of an oil-soluble sunscreen, based on the total weight of the composition.Non-ionic emulsifiers

[0032] The oil phase also includes at least a first non-ionic emulsifier and at least a second non-ionic emulsifiers. As used herein, a first non-ionic emulsifier has an HLB value from 13 to 20, preferably, from 13 to 19, more preferably, from 14 to 19, and most preferably, from 15 to 19, and a second non-ionic emulsifier has an HLB value from 2 to 8, preferably, from 3 to 8, and more preferably, from 4 to 8. In one aspect, the total amount of the first and the second non-ionic emulsifier is from 1 to 15 wt%, or from 2 to 10 wt%, or from 4 to 10 wt%, or from 5 to 10 wt%, or from 6 to 9 wt%, or from 6 to 8 wt%, based on the total weight of the composition. In one aspect, the weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15.

[0033] In one aspect, examples of the first non-ionic emulsifier include polyoxyethelene sorbitan monolaurate (or polysorbate 20), polyoxyethelene sorbitan monostearate (or polysorbate 60), polyoxyethelene sorbitan monoleate (or polysorbate 80), PEG-60 hydrogenated castor oil, PEG-100 stearate, polyethylene glycol 66012-hydroxystearate, poly(oxyethylene)(23) lauryl ether (or Brij 35), polyoxyethylene (20) cetyl ether (or Brij 58), cetearyl alcohol, ceteareth 20, sucrose laurate, sucrose myristate, sucrose palmitate, sucrose oleate, sucrose stearate. In one aspect, the first non-ionic emulsifier is PEG-100 stearate, cetearyl alcohol, ceteareth 20, or a combination thereof. In one aspect, the first non-ionic emulsifier is PEG-100 stearate, cetearyl alcohol or a combination thereof. In one aspect, the total amount of the first non-ionic emulsifier is from 1 to 10 wt%, or from 1 to 8 wt%, or from 2 to 8 wt%, or from 3 to 6 wt%, or from 3 to 5 wt%.

[0034] In one aspect, examples of the second non-ionic emulsifier include glycerol and / or polyglycerol esters of fatty acids like glyceryl stearate or triglycerol monostearate, propylene glycol esters of fatty acids like propylene glycol monostearate, and sorbitan esters of fatty acids, and fatty alcohols including caprylic alcohol, decyl alcohol, lauryl alcohol, oleyl alcohol, palm kernel alcohol, isostearyl alcohol, tridecyl alcohol, myristyl alcohol, and any combination thereof. In one aspect, the second non-ionic emulsifier is glyceryl stearate including glyceryl monostearate, glyceryl distearate, glyceryl tristearate, or any combination thereof. In one aspect, the total amount of the second non-ionic emulsifier is from 1 to 10 wt%, or from 2 to 8 wt%, or from 3 to 7 wt%, or from 3 to 5 wt%.In one aspect, the emulsion is substantially free of anionic and / or cationic emulsifiers.

[0035] Water phase

[0036] In one aspect, the composition has from 45 to 75 wt%, or from 50 to 70 wt%, or from 55 to 70 wt%, or from 58 to 67 wt%, or from 60 to 67 wt%, of water, based on the total weight of the composition.

[0037] In one aspect, the water phase optionally includes at least one humectant, such as water-soluble polyols. These include sorbitol, glycerol (or glycerine), mannitol, xylitol, maltitol and / or mixtures thereof. Other humectants include propylene glycol, dipropylene glycol, polypropylene glycol (e.g., PPG-9), polyethylene glycol, hydroxypropyl sorbitol, hexylene glycol, 1,3-butylene glycol, propanediol, 1,2-octane diol, 1,2-hexane diol, isoprene glycol, 1,2,6-hexanetriol, ethoxylated glycerol, propoxylated glycerol and / or mixtures thereof. In one aspect, the humectant is glycerol. In one aspect, the humectant is a combination of glycerol and hexylene glycol. In one aspect, the amount of humectant included, by weight of the composition described herein, is from 0.001 to 20 wt%, or from 0.001 to 15 wt%, or from 0.01 to 15 wt%, or from 0.1 to 10 wt%, or from 1 to 10 wt%, or from 2 to 10 wt%, or from 5 to 10 wt%, or from 7 to 10 wt%, including all ranges and amounts subsumed therein.

[0038] In one aspect, the pH of the composition is from 3 to 6, preferably, from 3.5 to 5.5, more preferably, from 3.5 to 5, and even more preferably, from 3.5 to 4.5, and most preferably, from 3.7 to 4.1. Adjusters suitable to modify the pH of the composition as described herein may be used. Such pH adjusters include but are not limited to triethylamine, NaOH, KOH, H2SO4, HCI, CeHsO? (i.e. , citric acid) and / or mixtures thereof. Buffers, like potassium oxide, to stabilize pH are also suitable for use. The pH of the composition is assessed by using conventional instrumentation such as a pH meter made commercially available from Thermo Scientific®.

[0039] Thickener

[0040] Additional components that can be added to the composition described herein, preferably, to an emulsion or the water phase, include thickeners. In one aspect, the composition includes from 0.45 to 2.75 wt%, or from 0.5 to 2 wt%, or from 0.5 to 1.5 wt%, or from 0.5 to 1 wt%, or from 0.5 to 0.9 wt% of a thickener, based on the total weight of the composition, wherein at least 65 wt%, preferably, from 65 to 100 wt%, more preferably, from 80 to 100 wt%, and even more preferably, from 95 to 100 wt% of the thickener comprises a first acryloyldimethyltauratepolymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer (e.g., Aristoflex® AVC), a natural or synthetic gum, a cellulosic, or a combination thereof. As used herein, a natural or synthetic gum includes xanthan gum, sclerotium gum, pectin, karaya gum, gum arabic, agar, guar gum, carrageenan, alginate, or any combinations thereof. As used herein, a cellulosic includes hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethylcellulose, sodium carboxymethylcellulose, or any combination thereof. Additionally, or alternatively, the cellulosic can be a cellulose liquid such as Arbalon® R-50 EV cellulose liquid. In one aspect, the thickener is ammonium acryloyldimethyltaurate / VP copolymer (e.g., Aristoflex® AVC).

[0041] In one aspect, the thickener further includes a second acryloyldimethyltaurate polymer comprising alkali metal ion and / or ammonium ion is selected from sodium acryloyldimethyltaurate / VP crosspolymer (Aristoflex® A VS), ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer (Aristoflex® HMB or Aristoflex® BLV), ammonium acryloyldimethyltaurate / carboxyethyl acrylate crosspolymer (Aristoflex® TAC), or any combination thereof. In one aspect, the composition is substantially free of the second acryloyldimethyltaurate polymer.

[0042] In one aspect, the thickener further includes crosslinked acrylic polymers including carbomers such as acrylate / C1-C30 alkyl acrylate type and / or homopolymers or copolymers of acrylic or methacrylic acids or the salts thereof and the esters thereof, including those sold under the name CARBOPOL®. In one aspect, the composition is substantially free of carbomer.

[0043] In one aspect, from 65 to 95 wt%, or from 75 to 95 wt%, or from 85 to 95 wt%, or from 90 to 95 wt% of the thickener is ammonium acryloyldimethyltaurate / VP copolymer (e.g., Aristoflex® AVC) with from 5 to 35 wt%, or from 5 to 25 wt%, or from 5 to 15 wt% comprising at a second acryloyldimethyltaurate polymer comprising alkali metal ion and / or ammonium ion is selected from sodium acryloyldimethyltaurate / VP crosspolymer (Aristoflex® AVS), ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer (Aristoflex® HMB or Aristoflex® BLV), ammonium acryloyldimethyltaurate / carboxyethyl acrylate crosspolymer (Aristoflex® TAC), a carbomer, or any combination thereof.

[0044] In one aspect, from 65 to 95 wt%, or from 75 to 95 wt%, or from 85 to 95 wt%, or from 90 to 95 wt% of the thickener is ammonium acryloyldimethyltaurate / VP copolymer (e.g., Aristoflex®AVC) with from 5 to 35 wt%, or from 5 to 25 wt%, or from 5 to 15 wt% comprising at least one of a natural gum, synthetic gum, and / or a cellulosic.

[0045] In one aspect, the viscosity of the composition is from 4,000 to 30,000 Pa.s, or from 5,000 to 25,000 Pa.s, or from 6,000 to 20,000 Pa.s, or from 7,000 to 18,000 Pa.s, or from 8,000 to 15,000 Pa.s, or from 9,000 to 14,000 Pa.s, measured at25°C, 10 1 / s shear rate, 1 mm gap, 30 second measurement, using a Discovery HR-2 Hybrid Rheometer.

[0046] Sensory Modifier

[0047] In one embodiment, the composition optionally includes a starch, but the starch is a sensory modifier as opposed to a thickening agent. As used herein, when starch is a sensory modifier, it is “unswelled”, meaning having a particle size of from 0.2 to 150 microns, preferably, from 1 to 50 microns, and more preferably, from 2 to 25 microns, when performed with Image J ParticleSizer (Fiji) analysis collected with Zeiss Axioplan microscope at 200x bright field, cross polarization and 400x DIG at 25°C to visualize starch structure (2% starch in water). A starch is also considered to be “unswelled” when it has a viscosity of from 2 to 18 mPa.s, preferably, from 3 to 15 mPa.s, more preferably, from 4 to 12 mPa.s, and most preferably, from 5 to 11 mPa.s, with 2% starch in water at 25°C, 101 / s shear rate, 25 mm gap, 30 second measurement, measured using a Discovery HR-2 Hybrid Rheometer. By contrast, a “swelled” starch has a viscosity of at least 20 mPa.s measured according to the same conditions noted above. Suitable starch for use as a sensory modifier includes tapioca starch, corn starch, and / or chemically modified starches such as sodium hydroxypropyl starch phosphate and aluminum starch octenylsuccinate. In one aspect, the composition includes from 0.01 to 5 wt%, or from 0.1 to 4 wt%, or from 0.5 to 4 wt%, or from 1 to 4 wt%, or from 1 to 3 wt%, of a sensory modifier, based on the total weight of the composition. In one aspect, when included, the viscosity of the composition changes by no more than 10%, preferably, no more than 5%, more preferably, no more than 2.5%, even more preferably, no more than 1.5%, even more preferably, no more than 1%, and most preferably, by no more than 0.5%. In one aspect, if desired to include sensory modifiers, they are included at a temperature of 55°C or below, preferably, from 20 to 55°C, more preferably, from 25 to 50°C, and most preferably, from 35 to 45°C.Benefit Agents

[0048] The composition disclosed herein also includes at least one benefit agent selected from alphahydroxy acid (AHA), a beta-hydroxy acid (BHA), a poly-hydroxy acid (PHA), or any combination thereof. Suitable alpha-hydroxy acids (AHAs) include glycolic acid, lactic acid, malic acid, citric acid, tartaric acid, mandelic acid, or any salts or combination thereof, preferably, glycolic acid and lactic acid, or any salts or combinations thereof. Suitable beta-hydroxy acids (BHAs) include salicylic acid, lipohydroxy acid, tropic acid, trethocanic acid, or any salts, or any combination thereof, preferably, salicylic acid or any salts or combinations thereof. Suitable poly-hydroxy acids (PHAs) include gluconolactone, lactobionic, maltogenic, gluconic acid, zinc gluconate, or any salts or combinations thereof, preferably, gluconolactone. Salts of these benefits agents include ammonium salts, sodium salts, and potassium salts, for example, sodium lactate, potassium lactate, ammonium lactate, ammonium glycolate, sodium glycolate, potassium glycolate. In one aspect, the benefit agents are at least one alpha-hydroxy acid (AHA), and at least one beta-hydroxy acid (BHA), and at least one poly-hydroxy acid (PHA). In one aspect, the benefit agents are salicylic acid, glycolic acid, lactic acid, and gluconolactone. In one aspect, the total amount of benefit agent(s) in the composition is from 0.5 to 15 wt%, or from 1 to 12 wt%, or from 3 to 12 wt%, or from 4 to 10 wt%, or from 5 to 10 wt%, or from 6 to 10 wt%, or from 7 to 10 wt%, based on the total weight of the composition, wherein at least 50%, preferably, from 50 to 100%, more preferably, from 60 to 100%, more preferably from 70 to 100%, more preferably, from 80 to 100%, and even more preferably from 90 to 100%, remains in the acid form as opposed to a salt form. In one aspect, the composition comprises from 2 to 8 wt%, or from 3 to 7 wt%, or from 4 to 6 wt% of free acid.

[0049] In one aspect, the total amount of alpha-hydroxy acids (AHAs), when included, is from 0.1 wt% to 10 wt%, or from 1 to 8 wt%, or from 2 to 8 wt%, or from 3 to 6 wt%, or from 3 to 5 wt%, based on the total weight of the composition. In one aspect, when alpha-hydroxy acid(s) are included, the alpha-hydroxy acids preferably, lactic acid to glycolic acid, and are present in a weight ratio of from 15:1 to 0.5:1, or from 10:1 to 0.5 to 1, or from 8:1 to 1:1, or from 6:1 to 2:1, or from 12:1 to 3:1, or from 10:1 to 4:1, or from 10:1 to 6:1.

[0050] In one aspect, the total amount of beta-hydroxy acids (BHAs), when included, is from 0.001 to 3 wt%, or from 0.01 to 2.5wt%, or from 0.1 to 2 wt%, or from 0.1 to 1.5 wt%, or from 0.25 to 1.75 wt%, or from 0.25 to 1.25 wt%, or from 0.25 to 1 wt%, or from 0.25 to 0.75 wt%, or from 0.35 to 1 wt%, or from 0.45 to 0.75 wt%, based on the total weight of the composition. In one aspect, ifthe total amount of BHAs includes salicylic acid, the composition has from 0.001 to 1.75 wt%, or from 0.01 to 1.5 wt%, or from 0.1 to 1.15 wt%, or from 0.1 to 1 wt%, of salicylic acid, based on the total weight of the composition.

[0051] In one aspect, the total amount of poly-hydroxy acids (PHAs), when included, is from 0.1 to 8 wt%, or from 0.5 to 6 wt%, or from 1 to 5 wt%, or from 2 to 5 wt%, or from 2.5 to 5 wt%, or from 3 to 5 wt%, or from 3.5 to 4.5 wt%, based on the total weight of the composition.

[0052] In one aspect, when both beta-hydroxy acids (BHAs) and poly-hydroxy acids (PHAs) are included, the weight ratio of total PHA to total BHA is from 20:1 to 0.5:1, or from 15:1 to 1:1, or from 10:1 to 2:1, or from 8:1 to 2:1.

[0053] In one aspect, the benefit agent can further include from 0.001 to 5 wt%, or from 0.01 to 4 wt%, or from 0.1 to 3 wt% of urea, tretinoin, and dehydroepiandrosterone (DHEA). In one aspect, the benefit agent is substantially free of urea, tretinoin, and dehydroepiandrosterone (DHEA).

[0054] Optional Skin Benefit Agents

[0055] Water-soluble vitamins may include vitamin B1 and its precursors or derivatives (such as thiamine), vitamin B3 and its precursors or derivatives (such as niacinamide); vitamin B5 and its precursors or derivatives (such as panthenol and its precursors or derivatives); vitamin B7, vitamin B9, vitamin C and its precursors or derivatives (such as tetrahexyldecyl ascorbate, ascorbyl palmitate); and alpha lipoic acid. When used, from 0.0001 to 10 wt%, or from 0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 to 2 wt%, or from 0.01 to 1 wt%, or from 0.5 to 3.5 wt%, or from 0.5 to 1.5 wt%, or from 1 to 3.5 wt%, or from 1 to 2 wt%, by weight of each of such ingredients, based on the total weight of the composition.

[0056] Further water-soluble actives include allantoin, pyroglutamic acid (PCA) and salts thereof including zinc PCA and sodium PCA, kojic acid, saccharide isomerate, and hyaluronic acid and salts thereof. When used, from 0.0001 to 10 wt%, or from 0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 to 2 wt%, or from 0.01 to 1 wt%, by weight of each of such ingredients are used, based on the total weight of the composition.

[0057] Oil-soluble vitamins include vitamin A and its precursors or derivatives including retinoids such as retinol, beta-carotene, retinal, retinoic acid and C2-20 esters of retinol (such as retinylpalmitate, retinyl propionate, retinyl formate, retinyl acetate, retinyl butyrate, retinyl valerate, retinyl isovalerate, retinyl hexanoate, retinyl heptanoate, retinyl octanoate, retinyl nonanoate, retinyl decanoate, retinyl undecandate, retinyl taurate, retinyl tridecanoate, retinyl myristate, retinyl pentadecanoate, retinyl heptadeconoate, retinyl stearate, retinyl isostearate, retinyl nonadecanoate, retinyl arachidonate, retinyl behenate, retinyl linoleate, and retinyl oleate); vitamin D and its precursors or derivatives, vitamin E and its precursors or derivatives (such as tocopherol, d-alpha-tocopherol, tocopheryl acetate); vitamin Kand its precursors or derivatives; selenium and its derivatives (such as L-selenomethionine). When used, from 0.0001 to 10 wt%, or from 0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 to 2 wt%, or from 0.01 to 1 wt%, or from 0.01 to 0.5 wt%, of each of such ingredients, based on the total weight of the composition.

[0058] A resorcinol, which is a monohydroxy phenol compound (i.e. , 1,3-dihydroxybenzene or 1,3-benzenediol) characterized by alcohol groups (—OH) at positions 1 and 3. The chemical structure of resorcinols may be modified, resulting in substituted resorcinols characterized by at least one substituent in the 2, 4, 5 or 6 position. Substituted, as used herein, refers to a compound in which one or more hydrogen atoms are replaced by another atom or group, e.g., substituent. In one aspect, the substituted resorcinol comprises at least one substituent comprising 5 to 11 carbon atoms, or 5 to 9 carbon atoms. In one aspect, the substituted resorcinol has at least one substituent comprised of an alkyl group or unsaturated alkyl group.

[0059] In one aspect, the substituted resorcinol is only substituted at position 4 with an alkyl group, e.g., the substituted resorcinol is a 4-substituted alkyl resorcinol, including but not limited to 4-methyl resorcinol, 4-ethyl resorcinol, 4-hexyl resorcinol, 4-cyclohexyl resorcinol, 4-propyl resorcinol, 4-isopropyl resorcinol, 4-butyl resorcinol, 4-pentyl resorcinol, 4-phenylethyl resorcinol, 4-cyclopentyl resorcinol, 4-cyclohexyl resorcinol, 4-heptyl resorcinol, 4-cycloheptyl resorcinol, 4-octyl resorcinol, 4-cyclooctyl resorcinol, 4-nonyl resorcinol, 4-decyl resorcinol, 4-undecyl resorcinol, 4-dodecyl resorcinol and / or combinations or mixtures thereof. Preferably, the substituted resorcinol is 4-ethylresorcinol, 4-hexylresorcinol, and 4-isopropylresorcinol. In one aspect, the substituted resorcinol is substituted at position 4 with a substituted or unsubstituted 5- or 6-membered ring carbon-based heterocyclic ring containing one or more heteroatoms selected from N, S or O, preferably a substituted 5-membered ring carbon-based heterocyclic ring containing two heteroatoms selected from N or S, e.g., isobutylamido thiazolyl resorcinol or thiamidol. When used, from 0.0001 to 10 wt%, or from 0.0001 to 5 wt%, or from0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 to 2 wt%, or from 0.01 to 1 wt%, or from 0.01 to 0.5 wt%, by weight of each of such ingredients, based on the total weight of the composition.

[0060] Glutathione precursors such as a glutamate source (e.g., glutamate) and cystine and, optionally, glycine, as well as salts and esters thereof. Glutamate source can be present in the form of its functional equivalents including glutamine, glutamic acid and / or pyroglutamic acid and / or their salts. In another aspect, a carboxymethyl cysteine compound can be used. The carboxymethyl cysteine compound refers to compound selected from carboxymethyl cysteine, salt of carboxymethyl cysteine, ester of carboxymethyl cysteine, amide of carboxymethyl cysteine or a mixture thereof. Preferably, the carboxymethyl cysteine compound comprises carboxymethyl cysteine, ester of carboxymethyl cysteine, and / or salt of carboxymethyl cysteine. More preferably, the carboxymethyl cysteine compound comprises carboxymethyl cysteine, and / or salt of carboxymethyl cysteine. Even more preferably, carboxymethyl cysteine compound comprises salt of carboxymethyl cysteine. Still even more preferably the carboxymethyl cysteine compound comprises lysine carboxymethyl cysteinate and most preferably, the carboxymethyl cysteine compound is lysine carboxymethyl cysteinate. When used, from 0.0001 to 10 wt%, or from 0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 wt% to 2 wt%, or from 0.01 wt% to 1 wt%, by weight of each of such ingredients, based on the total weight of the composition.

[0061] A peroxisome proliferator-activated receptor (PPAR) activator such as 10-hydroxystearic acid (10-HSA), 12-hydroxystearic acid (12-HSA), cis-parinaric acid, trans-7-octadecenoic acid, cis-5,8,11,14,17 eicosapentanoic acid, cis-4, 7, 10, 13, 16, 19 docosahexenoic acid, conjugated linoleic acid (c9,t11), columbinic acid, linolenelaidic acid, ricinolaidic acid, stearidonic acid, 2-hydroxystearic acid, alpha-linolenic acid, arachidonic acid, cis-11,14-eicosadienoic acid, conjugated linoleic acid (t10,c12), conjugated linoleic acid (t9,t11), conjugated linoleic acid (50:50 mix of c9, t11 and t10 d 2), coriander acids, linolelaidic acid, monopetroselinic acid, petroselinic acid, ricinoleic acid, stearolic acid, thuja extract or trans vaccenic acid. Even other PPAR activators include cis-11,14,17 eicosatrienoic acid, cis-5 eicosenoic acid, cis-8,11,14 eicosatrienoic acid, hexadecatrienoic acid, palmitoleic acid, petroselaidic acid, farnesol, cis-13,16 docosadienoic acid, cis vaccenic acid, cis-11 eicosenoic acid, cis-13, 16, 19 docosatrienoic acid, cis-13-octadecenoic acid, cis-15-octadecanoic acid, cis-7,10,13, 16 docosatetraenoic acid, elaidic acid, gamma-linolenic acid, geranic acid, geranyl geranoic acid, linoleic acid, petroselinylalcohol, phytanic acid, pinolenic acid, trans-13-octadecenoic acid or tridecyl salicylic acid (TDS). Still other PPAR activators include biochanin A (red clover phytoestrogen), chromolaena odorata extract, pomegranate saponifiable hydrolysable extract, buglossoides (stearidonic plant extract) or zanthalene (extract from Sichuan peppercorn), whereby it is within the scope of the invention to use a mixture of any of the herein noted PPAR activators. In an embodiment of the invention, the PPAR activator is petroselinic acid, conjugated linoleic acid, 12-hydroxystearic acid, ricinoleic acid or a mixture thereof. When used, from 0.0001 to 10 wt%, or from 0.001 to 8 wt%, or from 0.01 to 5 wt%, or from 0.01 to 3 wt%, or from 0.01 to 2 wt%, or from 0.01 to 1 wt%, or from 0.01 to 0.5 wt%, by weight of each of such ingredients, based on the total weight of the composition.

[0062] Other optional skin care benefit agents include S-adenosyl-L-methionine, a 1 -alkyl nicotinamide having structure I, and a methionine having structure II:

[0063]

[0064] wherein Rcis a C1-C4 alkyl, preferably, methyl (N-methyl nicotinamide) and X- is a negative counter ion, preferably, CI-, Rdis methyl, ethyl, propyl, hydroxymethyl, 2-hydroxyethyl, preferably, methyl and Reis H, methyl, ethyl, isopropyl, preferably, H (N-acetyl methionine). Such components are described in WO 2021 / 008824 A1, the disclosure of which is incorporated herein by reference. In even another embodiment, the microemulsion may comprise acetyl cysteine. When used, from 0.001 wt% to 4.5 wt%, or from 0.01 wt% to 3.5 wt%, or from 0.01 wt% to 2.5 wt% or from 0.01 wt% to 1 wt%, or 0.01 wt% to 0.5 wt%, or 0.01 to 0.3 wt%, or 0.1 wt% to 0.3 wt%, by weight of each of such ingredients, based on the total weight of the microemulsion.

[0065] Other optional skin care benefit agents include at least one of benzethonium chloride, benzalkonium chloride, cetrimonium chloride, zinc pyrithione, dihydroxyacetone (DHA), chloroxylenol, eugenol, terpineol, thymol, selenium sulfide, piroctone olamine, hinokitiol, linalool, cinnamon oil, lemon grass oil, eucalyptus, vanilla extract, mint extract, orange extract, or a mixture thereof. If any of such are selected for use, the total amount of those selected for use will (in combined total) be from 0.001 wt% to 4.5 wt%, or from 0.01 wt% to 3.5 wt%, or from 0.01 wt% to 2.5 wt% or from 0.02 wt% to 1 wt%, based on the total weight of the emulsion.Other optional skin care benefit agents include ceramides (e.g., ceramide 1, ceramide 3 and / or ceramide 6). In one aspect, the composition is substantially free of ceramides.

[0066] Conventional preservatives can desirably be incorporated into the composition to protect against the growth of potentially harmful microorganisms. Cosmetic chemists are familiar with appropriate preservatives and routinely choose them to satisfy the preservative challenge test and to provide product stability. While traditional preservatives may be used, such as hydantoin derivatives, isothiazolinones, methyl paraben and / or propyl paraben, as described herein the emulsion of the present invention is preferably substantially free of the same. Other preservatives suitable for use may include iodopropynyl butyl carbamate, phenoxyethanol, hydroxyacetophenone, ethylhexylglycerine, hexylene glycol, imidazolidinyl urea, sodium dehydroacetate, benzyl alcohol, sodium benzoate or mixtures thereof. Even other preservatives suitable for use include sodium dehydroacetate, chlorophenesin and decylene glycol. The preservatives should be selected having regard for the use of the emulsion and possible incompatibilities between the preservatives and other ingredients in the emulsion. Preservatives are preferably employed in amounts from 0.01 wt% to 2.0 wt%, based on the total weight of the sunscreen emulsion. Also preferred is a preservative system with hydroxyacetophenone alone or in a mixture with other preservatives. Use of common emollients classified as vicinal diols, like 1,2-octane diol (or other vicinal alkane diols), are also suitable for use with the preservatives described herein and typically at amounts ranging from 0.15 to 1.5 wt%, or from 0.2 to 1.25 wt%, or from 0.25 to 1 wt%, or from 0.25 to 0.8 wt%, based on the total weight of the emulsion. In another embodiment of the invention, another preservative suitable for optional use in the present invention comprises capryloyl glycine, undecylenoyl glycine or a mixture thereof. In one aspect, the emulsion is substantially free of parabens.

[0067] Fragrances, fixatives, opacifiers (like titanium dioxide), chelators (like EDTA) may optionally be included in the composition as disclosed herein. The amount of optional fragrances, fixatives, opacifiers, and chelators included, by weight of the composition described herein, is collectively from 0.001 to 3 wt%, or from 0.01 to 3 wt%, or from 0.01 and 2 wt%, or from 0.01 to 1 wt%, or from 0.05 to 2 wt%, or from 0.05 to 1 wt%, including all ranges subsumed therein.

[0068] Antioxidants are suitable for optional use including natural, naturally derived, or synthetic antioxidants. Illustrative but nonlimiting examples of such antioxidants comprise butylated hydroxytoluene (BHT), carotenes, carotenoids, co-enzyme Q10, didodecyl 3,3' thiodipropionate,glutathione, imidazole and derivatives thereof, octadecyl di-t-butyl-4-hydroxyhydrocinnamate, peptides and derivatives thereof, plant extracts (e.g., Rosmarinus officinalis (rosemary) leaf extract, Camellia sinesis (green tea) leaf extract, Apium graveolens (celery) seed extract, and / or Linum usitatissimum (linseed) seed extract), polyphenols (e.g., anthocyanin, ellagic acid, flavonoid, tannin), and resveratrol. Other examples of suitable antioxidants include Tinogard® TT which is the phenolic antioxidant under the chemical name Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, and Tinogard® Q (Tris-(Tetramethylhydroxy-piperidinol)citrate), that is made commercially available from BASF.

[0069] In one aspect, the present invention is directed to a composition comprising: (a) at least one oil wherein the oil is an emollient oil, a silicone oil, or a combination thereof, preferably, the at least oil comprises a fatty acid, an ether, or a combination thereof, more preferably, comprising stearic acid, palmitic acid, dicaprylyl ether, dimethicone, or a combination thereof, and includes at least one oil-soluble sunscreen, preferably, 3,3,5-trimethylcyclohexyl 2-hydroxybenzoate, ethylhexyl salicylate, ethylhexyl methoxycinnamate, 2-ethylhexyl 2-cyano-3,3-diphenylprop-2-enoate, 4-t-butyl-4’-methoxydibenzoylmethane, or a combination thereof; (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15; (c) from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably, from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein at least 65%, preferably, from 65 to 100 wt%, more preferably, from 80 to 100 wt%, and even more preferably, from 95 to 100 wt% of the thickener comprises a first acryloyldimethyltaurate polymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer, a natural or synthetic gum, a cellulosic, or a combination thereof, preferably, ammonium acryloyldimethyltaurate / VP copolymer; and (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), a beta-hydroxy acid (BHA), a poly-hydroxy acid (PHA), or any salt, or any combination thereof. In one aspect, the composition comprises at least one humectant. In one aspect, the composition further includes at least one skin benefit agent.

[0070] In one aspect, the present invention is directed to a composition comprising: (a) at least one oil wherein the oil is a hydrocarbon oil, an emollient oil, a silicone oil, or a combination thereof,preferably, comprises at least one of a fatty acid, an ether, a silicone oil, or any combination thereof, and includes at least one oil-soluble sunscreen, preferably, ethylhexyl methoxycinnamate and 4-t-butyl-4’-methoxydibenzoylmethane; (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15, wherein the first non-ionic emulsifier comprises PEG-100 stearate, cetearyl alcohol, ceteareth 20, or a combination thereof, and wherein the second non-ionic emulsifier comprises glyceryl stearate; (c) from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably, from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein at least 65%, preferably, from 65 to 100 wt%, more preferably, from 80 to 100 wt%, and even more preferably, from 95 to 100 wt% of the thickener comprises a first acryloyldimethyltaurate polymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer, a natural or synthetic gum, a cellulosic, or a combination thereof, preferably, ammonium acryloyldimethyltaurate / VP copolymer; and (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), preferably, glycolic acid, lactic acid, or a combination thereof, a beta-hydroxy acid (BHA), preferably, salicylic acid, a poly-hydroxy acid (PHA), preferably, gluconolactone, or any salt, or any combination thereof. In one aspect, the composition comprises at least one humectant. In one aspect, the composition further includes at least one skin benefit agent.

[0071] In one aspect, the present invention is directed to a composition comprising: (a) at least one oil wherein the oil is a hydrocarbon oil, an emollient oil, or a combination thereof, preferably, comprises at least one of a fatty acid, an ether, or any combination thereof, and substantially free of a silicone oil, and includes at least one oil-soluble sunscreen, preferably, ethylhexyl methoxycinnamate and 4-t-butyl-4’-methoxydibenzoylmethane; (b) a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1:0.75 to 1:1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15 , wherein the first non-ionic emulsifier comprises PEG-100 stearate, cetearyl alcohol, ceteareth 20, or a combination thereof, and wherein the second non-ionic emulsifier comprises glyceryl stearate; (c) from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably,from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein from 65 to 95 wt%, of the thickener is a first acryloyldimethyltaurate polymer comprising an alkali metal ion and / or an ammonium ion selected from ammonium acryloyldimethyltaurate / VP copolymer, a natural or synthetic gum, a cellulosic, or a combination thereof, preferably, ammonium acryloyldimethyltaurate / VP copolymer; and from 5 to 35 wt% of the thickener is a second acryloyldimethyltaurate polymer (d) at least one benefit agent, wherein the at least one benefit agent is selected from alpha-hydroxy acid (AHA), preferably, glycolic acid, lactic acid, or a combination thereof, a beta-hydroxy acid (BHA), preferably, salicylic acid, a poly-hydroxy acid (PHA), preferably, gluconolactone, or any salt, or any combination thereof. In one aspect, the composition comprises at least one humectant. In one aspect, the composition further includes at least one skin benefit agent.

[0072] In one aspect, a method to prepare the composition as described herein, includes: (a) preparing an oil phase comprising mixing: at least one oil, a first non-ionic emulsifier, a second non-ionic emulsifier, and optionally, an oil-soluble sunscreen and at least one skin care benefit agent, preferably, at a temperature of from 60 to 100°C, preferably, from 65 to 90°C, and more preferably, from 65 to 80°C; and (b) preparing a water phase comprising: mixing water, a humectant, and a thickener, and heating to a temperature of from 45 to 80°C, preferably, from 50 to 75°C, and more preferably, 65 to 70°C, (c) combining the water phase and the oil phase, homogenizing to form an emulsion, (d) cooling the emulsion of step (c) to from 35 to 55°C, preferably, from 37 to 52°C, and more preferably, from 40 to 50°C, (e) following the cooling in step (d) adding at least one AHA (e.g., salicylic acid), at least one BHA (e.g., glycolic acid and lactic acid), and at least one PHA (e.g., gluconolactone), and optionally, at least one skin care benefits agent, preservatives, pH adjusters, and / or sensory modifiers, wherein if sensory modifiers are included, they are unswelled sensory modifiers.

[0073] In one aspect, a method to prepare the composition as described herein, includes: (a) preparing an oil phase comprising mixing: at least one oil, a first non-ionic emulsifier, a second non-ionic emulsifier, and optionally, an oil-soluble sunscreen and at least one skin care benefit agent, preferably, at a temperature of from 60 to 100°C, preferably, from 65 to 90°C, and more preferably, from 65 to 80°C; and (b) preparing a water phase comprising: mixing water and a humectant, and heating to a temperature of from 45 to 80°C, preferably, from 50 to 75°C, and more preferably, 65 to 70°C (c) combining the water phase and the oil phase and adding a thickener, (d) homogenizing to form an emulsion, and (e) cooling the emulsion from step (d) tofrom 35 to 55°C, preferably, from 37 to 52°C, and more preferably, from 40 to 50°C, (f) following the cooling in step (e) adding at least one AHA (e.g., salicylic acid), at least one BHA (e.g., glycolic acid and lactic acid), and at least one PHA (e.g., gluconolactone), and optionally, at least one skin care benefits agent, preservatives, pH adjusters, and / or sensory modifiers, wherein if sensory modifiers are included, they are unswelled sensory modifiers.

[0074] Methods

[0075] The present invention is also directed to treatment keratosis pilaris by topical application of the composition described herein. “Treatment of keratosis pilaris”, as used herein, means the reduction in the visible signs of keratosis pilaris including the reduction of raised bumps (or papules) on the skin and / or reduced redness by topical application of the composition of the invention to a subject in need thereof having an affected area of skin. Preferably, topical application can be up to three times per day, preferably, twice per day, or once per day, for from 1 to 24 weeks, preferably, from 2 to 18 weeks, and more preferably, from 2 to 14 weeks, and most preferably, from 2 to 12 weeks, in an amount to cover the affected area. In one aspect, treatment continues until all physical symptoms (e.g., raised bumps / papules and redness) are no longer visible based on human observation. A subject in need thereof is a human including both males and females of all ages - including children and adults, exhibiting at least one visible symptom of keratosis pilaris (e.g., raised bumps / papules and redness).

[0076] The present invention is also directed to use of the composition disclosed herein for treatment of keratosis pilaris.

[0077] The following examples are provided to facilitate an understanding of the invention. The examples are not intended to limit the scope of the claims.

[0078] Examples

[0079] Example 1

[0080] A topical composition according to the present invention was prepared according to methods known by a person skilled in the art. For example, the ingredients of the oil phase (e.g., oil(s), the first and second non-ionic emulsifiers, oil-soluble sunscreens, and optionally, at least one skin benefit agent, e.g., oil-soluble vitamins) are combined and heated to 65 to 80°C. Then the water phase ingredients (e.g., water and humectant, e.g., glycerol) are added to the oil phaseingredients and mixed for 10 to 15 minutes. Then the thickener is added and mixed for about 10 to 15 minutes, followed by homogenization and cooling to 40 to 55°C and adding benefits agents including at least one AHA (e.g., salicylic acid), at least one BHA (e.g., glycolic acid and lactic acid), and at least one PHA (e.g., gluconolactone), and optionally add optional skin care benefits agents, preservatives, pH adjusters, and sensory modifiers, chelating agents.

[0081] Comp. 1

[0082]

[0083]

[0084] Surprisingly and unexpectedly, the composition not only was the composition used for the successful treatment of keratosis pilaris, but also it was acceptable for sensitive skin (e.g., did not cause any additional irritation) while also providing moisturization to skin.

[0085] Example 2

[0086] Additional samples were prepared as described in Example 1. Stability was visually measured at 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks at 5°C, 25°C, 37°C, 45°C, and 50°C. Visual assessment was completed to determine stable based on whether there was visual separation.

[0087] Table 1

[0088]

[0089] P0001278WG

[0090] 24

[0091]

[0092] Each of samples A-l used starch as a thickening agent (e.g., swelled starch), varying the amounts of the non-ionic emulsifiers and benefit agents, and it was not possible to make a stable emulsion. Each of samples A-F and H visually separated after 1 week at 50°C, sample I 5 visually separated after 4 weeks at 45°C, and sample G visually separated after 8 week at 45°C.

[0093] Table 2

[0094]

[0095] 10 Sample J used carbomer as the thickening agent, and it was not possible to make a stable emulsion. Sample J visually separated after 1 week at 50°C,

[0096] Table 3

[0097]

[0098]

[0099] Surprisingly and unexpectedly, each of samples 1-6 are in accordance with the present application and were stable emulsions, and did not separate after any of the stability tests conducted (i.e. , no visual separation at 12 weeks at 50°C). Samples K-R were not stable and visual separation occurred. Sample K visually separated after 12 weeks at 50°C, sample L, O, and P visually separated after 8 weeks at 50°C, and samples M, N, Q and R visually separated after 1 week at 50°C.

Claims

Claims1. A composition comprising:at least one oil wherein the at least one oil is a hydrocarbon oil, an emollient oil, a triglyceride, a silicone oil, or any combination thereof, and optionally comprising at least one oil-soluble sunscreen;a first non-ionic emulsifier having an HLB from 13 to 20, and a second non-ionic emulsifier having an HLB from selected from 2 to 8, wherein a weight ratio of the first non-ionic emulsifier to the second non-ionic emulsifier is from 1 :0.75 to 1 : 1.35, preferably, from 1:0.875 to 1:1.25, and more preferably, from 1:0.95 to 1:1.15;from 0.45 to 2.75 wt%, preferably, from 0.5 to 2 wt%, more preferably, from 0.5 to 1.5 wt%, and more preferably, from 0.5 to 1 wt%, and most preferably, from 0.5 to 0.9 wt% of a thickener, based on the weight of the composition, wherein the thickener is ammonium acryloyldimethyltaurate / VP copolymer;at least one poly-hydroxy acid is selected from gluconolactone, lactobionic, maltogenic, gluconic acid, zinc gluconate, or any combination thereof, preferably, gluconolactone; andat least one benefit agent selected from alpha-hydroxy acid (AHA), a betahydroxy acid (BHA), or any salt or any combination thereof.

2. The composition of claim 1 , wherein a pH of the composition is from 3 to 6, preferably, from 3.5 to 5.5, more preferably, from 3.5 to 5, even more preferably, from 3.5 to 4.5, and most preferably, from 3.7 to 4.1.

3. The composition of any of the preceding claims, wherein the composition further comprises a second acryloyldimethyltaurate polymer comprising alkali metal ion and / or ammonium ion is selected from sodium acryloyldimethyltaurate / VP crosspolymer, ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer, ammonium acryloyldimethyltaurate / carboxyethyl acrylate crosspolymer, or any combination thereof4. The composition of any of the preceding claims, wherein the natural or synthetic gum is xanthan gum, sclerotium gum, pectin, karaya gum, gum arabic, agar, guar gum, carrageenan, alginate, or any combinations thereof.

5. The composition of any of the preceding claims, wherein the cellulosic is hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethylcellulose, sodium carboxymethylcellulose, or any combination thereof.

6. The composition of any of the preceding claims, wherein a total amount of the at least one oil is 1 to 15 wt%, preferably, from 1 to 10 wt%, more preferably, from 1 to 8 wt%, even more preferably, from 1 to 5 wt%, even more preferably, from 2.5 to 10 wt%, even more preferably, from 2.5 to 7.5 wt%, and most preferably, from 2.5 to 5 wt%, based on the total weight of the composition.

7. The composition of any of the preceding claims, wherein the alpha-hydroxy acid is selected from glycolic acid, lactic acid, mandelic acid, malic acid, citric acid, tartaric acid, or any salts or combination thereof, preferably, glycolic acid and lactic acid, and wherein weight ratio of lactic acid to glycolic acid is from 15:1 to 2:1, preferably, from 12:1 to 3:1, more preferably, from 10:1 to 4:1, and even more preferably, from 10:1 to 6:1.

8. The composition of any of the preceding claims, wherein the beta-hydroxy acid is selected from salicylic acid, tropic acid, trethocanic acid, or any combination thereof, preferably, salicylic acid, wherein a total amount of the beta-hydroxy acid in the composition is from 0.001 to 3 wt%, or from 0.01 to 2.5 wt%, or from 0.1 to 2 wt%, or from 0.1 to 1.5 wt%, or from 0.25 to 1.75 wt%, or from 0.25 to 1.25 wt%, or from 0.25 to 1 wt%, or from 0.25 to 0.75 wt%, or from 0.35 to 1 wt%, or from 0.45 to 0.75 wt%, based on the total weight of the composition.

9. The composition of any of the preceding claims, wherein a total amount of the polyhydroxy acid in the composition is from 0.1 to 8 wt%, or from 0.5 to 6 wt%, or from 1 to 5 wt%, or from 2 to 5 wt%, or from 2.5 to 5 wt%, or from 3 to 5 wt%, or from 3.5 to 4.5 wt%, based on the total weight of the composition.

10. The composition of any of the preceding claims, wherein the composition is an oil-in-water emulsion, and further comprising water and at least one humectant, preferably, glycerin.

11. The composition of any of the preceding claims further comprising at least one optional skin benefit agent, preferably, 12-hydroxystearic acid, at least one oil-soluble vitamin, at least one water-soluble vitamin, at least one resorcinol, or any combination thereof.

12. A method for treating keratosis pilaris comprising topically applying the composition of any of the preceding claims to a subject in need thereof.

13. Use of the composition of claims 1-12 for treatment of keratosis pilaris.

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