Topical compositions for tanscreen comprising ecamsule and uses thereof

Abstract

The disclosure relates to skincare compositions comprising at least one melanin reducing agent; some percent of ecamsule; and at least one additional ingredient; wherein the ecamsule is the sole ultraviolet protecting compound.

Description

TOPICAL COMPOSITIONS FOR TANSCREEN COMPRISING ECAMSULE AND USES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Appl. Ser. No. 63 / 362,292, filed March 31 , 2022, which is incorporated by reference as if fully set forth herein.BACKGROUND

[0002] Currently, there is a gap in the sunscreen market. Sunscreen is formulated for the white population. And this excludes people of color. The white population is twenty times more likely to suffer from melanoma than African Americans and other people of color (for example, people of Indian, African, and Hispanic descent). It is widely understood that the white population has an increased chance of suffering from skin cancer compared to people of color due to the melanin people of color have in their skin. People of color’s increased melanin protects cells from various forms of sun damage and makes them less likely to experience a sunburn. Thus, people of color do not necessarily need the same type of sunscreen as the white population do. People of color need different protectants that do not fall under the sunscreen category.SUMMARY

[0003] People of color need protection from the sun but not the same type of protection that the white population need. People of color might need protection because exposure to sun causes their skin to age and increase in pigmentation. This increased pigmentation can lead to discoloration and uneven skin tone. This disparity between the needs of people of color and the white population can be further explained by the two different types of ultraviolet radiation (UV), namely, UVA and UVB. Approximately 95% of the sun’s rays are UVA radiation, while only 5% of the sun’s UV rays are UVB radiation. UVA radiation is responsible for, among other things, some skin cancers, premature aging, wrinkles, tanning / increased pigmentation, and discoloration. UVB radiation, on the other hand, is primarily responsible for most to skin cancers and sunburns. Most brown skinned people have inherent protection against skin cancers and sunburn. Yet, they desire protection against aging and hyper-pigmentation or tanning. Thus, people of color could benefit from products that provide primarily protection from UVA radiation, as opposed to UVB radiation or broader spectrum UV radiation protection. And the compositions described herein address this need.

[0004] Most, if not all sunscreens on the market currently protect against UVA radiation and UVB radiation. But the sun protection factor (SPF) associated with the sunscreen products only refer to the UVB radiation protection. UVB radiation protectants include chemicals such as titanium oxide, zinc oxide, octisalate, oxybenzone, and homosalate. The aforementioned ingredients have some correlation to, among other things, being harmful for humans, marine wildlife, and coral reefs. In addition, they need to be reapplied every two hours. By using increased amounts of sunscreen people of color are harming themselves and the environment without directly focusing on protecting themselves from UVA radiation. There is also a chemical called avobenzone which is used in some sunscreen products that protects from UVA radiation, which is known to have some harmful effects to humans, marine wildlife, and coral reefs.

[0005] For the aforementioned reasons, the disclosure is directed to, among other things, compositions that are made specifically for people of color with the primary ingredient being ecamsule as the sole ultraviolet protecting compound. Until now, ecamsule has been used in conjunction with other ingredients to cover a broad spectrum of sun protection (UVA and UVB) that the white population need. Ecamsule protects against UVA and some UVB for 24 hours. In addition, it has little percutaneous absorption and little systemic effects. Ecamsule is photo-stable and not photo mutagenic. This is significantly different from, for example, avobenzone (a common ingredient used in sunscreen) that is not photo-stable and requires photo stabilizers to prevent significant degradation in light. Avobenzone, in contrast, can cause a chemical reaction with chlorine (for example in water) forming new compounds that could result in kidney and liver dysfunction and nervous system disorders.

[0006] One notable benefit of the compositions described herein, which compositions comprise ecamsule, is that they need only be applied once a day. That is at least because ecamsule does not degrade in sunlight, like many of the sunscreen ingredients in sunscreen products in the market. Many, if not all of those products require re-application every two hours.

[0007] Another notable benefit of the compositions described herein, which compositions comprise ecamsule, is that they are not thick, such that they feel like a separate layer on a user’s skin. Further, the compositions described herein do not cause a user’s darker skin to look “ghostly” or “white.” Instead,the compositions described herein blend in naturally, do not look “ghostly,” and do not look shiny when applied to a user’s darker skin.

[0008] Yet another benefit of the compositions described herein is that they do not contribute to vitamin D deficiency when used every day to reduce or prevent darkening of a user’s already dark skin. Vitamin D deficiency becomes a significant issue if users with darker skin were to use sunscreen on a daily basis, as vitamin D deficiency has been linked to increased incidence of chronic diseases. See, e.g., https: / / www.sciencedaily.com / releases / 2017 / 05 / 170501102258.htm (visited September 28, 2022). Sunscreens, because they contain agents to protect against UVB radiation, contribute to Vitamin D deficiency. This exacerbates the already low levels of Vitamin D in black and presumably darker skin populations generally, due to the natural pigmentation of their skin. See, e.g., https: / / pubmed.ncbi.nlm.nih.gov / 16549493 / (visited Oct 3, 2022).DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is photographs showing no significant / substantial tanning in areas of the body of four volunteers / ”patients” to which compositions according to the disclosure have been applied to areas of the body that were not usually exposed to sunlight.

[0010] FIG. 2 is a photograph showing the appearance of various lotions / sunscreens on a user’s skin (arm).

[0011] FIG. 3 is a photograph showing tanning of a user’s skin (legs) when a sunscreen is used.

[0012] FIG. 4 is a photograph showing tanning of a user’s skin (back) when a sunscreen is used.DESCRIPTION

[0013] Reference will now be made in detail to certain embodiments of the disclosed subject matter. While the disclosed subject matter will be described in conjunction with the enumerated claims, it will be understood that the exemplified subject matter is not intended to limit the claims to the disclosed subject matter.

[0014] The disclosure provides various compositions for body and face applications, that protect against pigmentation or aging, while not exposing the body or face to the harmful effects of agents that protect against broader spectrum UVB radiation. Broader spectrum UVB agents generally have harmful effects that people of color can avoid because they do not necessarily require protection against this wavelength of ultraviolet radiation. Also, theUVB-protecting sunscreens generally require reapplication every few hours to remain effective. Furthermore, the UVB-protecting compounds can and do often cause a “ghostly” look for people of color, which is undesirable. Accordingly, it is desirable to have products, or tanscreens, for people of color that protect against pigmentation, tanning or aging, that do not contain UVB- protecting compounds. Further, it is desirable to have tanscreens for people of color that protect against UVA radiation, without exposing those individuals to harmful, UVB-protecting chemicals.

[0015] In some embodiments, the present invention discloses topical compositions, comprising a suitable percentage / concentration of a lotion, and ecamsule, where the compositions do not additionally contain compounds that are used to protect against broad spectrum UVB radiation. In one embodiment, the compositions comprise 5% ecamsule or less of the entire composition. At present, the FDA has approved ecamsule concentration of 5% or less. However, the composition may include higher percentages to accommodate prospective modifications relating to FDA-approved levels of ecamsule. In some embodiments, topical compositions are contemplated herein for application to body or face surfaces, where the compositions comprise an off-the-shelf lotion, and 5% or less ecamsule, where the compositions do not contain any broad spectrum UVB-protecting compounds (for example, octinoxate, para-aminobenzoic acid (PABA), and trolamine salicylate PABA).

[0016] The disclosure generally relates to skincare compositions. Some embodiments of the skincare compositions described herein comprise: at least one melanin reducing agent; some percent of ecamsule; and at least one additional ingredient; wherein the ecamsule is the sole ultraviolet protecting compound.

[0017] The skincare compositions described herein are not sunscreen compositions and, as such, do not / are not meant to protect against sunburn or skin cancer provided by broad spectrum UVR protection. But the skincare compositions described herein can avoid tanning or darkening of the skin of people of color that results from sun exposure. The disclosure therefore relates to, among other things, a method for substantially avoiding tanning or darkening of the skin of a person of color, the tanning or darkening of the skin resulting from sun exposure of the skin of people of color, the method comprising applying an amount of a composition described herein to the skinof a person of color effective to substantially avoid tanning or darkening of the skin. As such, the methods described herein are for compositions for a tanscreen, as opposed to the well-known sunscreen market.

[0018] An example of the skincare compositions contemplated herein is a skincare composition comprising:(i) less than about 5% ecamsule or a salt thereof by weight of the composition, or(ii) at least about 5% ecamsule or a salt thereof by weight of the composition; and at least one additional ingredient; wherein the composition does not comprise any additional broad spectrum ultraviolet light protecting agents (for example, bemotrizinol, avobenzone, bisoctizole, benzophenone-3 (BZ-3, oxybenzone), and octocrylene) that is harmful to humans, marine wildlife or coral.

[0019] For example, the skincare compositions described herein can comprise less than about 5% ecamsule (for example, less than about 4%, less than about 3%, less than about 2%, less than about 1 %, less than about 0.5%, from about 0.1 % to about 5%, about 1 % to about 5%, about 2% to about 5%, about 0.5% to about 5% or about 2.5% to about 5% by weight of the composition). Alternatively, the skincare compositions described herein can comprise at least about 5% ecamsule (for example, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, from about 5% to about 15%, about 5% to about 10%, about 7% to about 10%, about 6% to about 12% or about 8% to about 10% by weight of the composition).

[0020] Any reference to percent (%) mentioned in the disclosure can be by weight, volume, or any other form that one skilled in the art would understand or use to prepare the skincare compositions described herein. It can apply to liquids, salts, powders or any other form that an agent, chemical, polymer, mixture, compound, molecule or substrate is available, purchased, or synthesized for the purposes of the disclosure. The overall composition or mixture can be in any suitable form for topical application, for example, liquid (e.g., as a lotion), or a spray for ease of application.

[0021] As used herein, the term “ecamsule” generally refers to a compound of the formula:and salts thereof. Ecamsule is also known by its IUPAC name [(3Z)-3-[[4-[(Z)- [7,7-dimethyl-2-oxo-1 -(sulfomethyl)-3- bicyclo[2.2.1 ]heptanylidene]methyl]phenyl] methylidene]-7,7-dimethyl-2-oxo- 1 -bicyclo[2.2.1 ]heptanyl]methanesulfonic acid and salts thereof. The term “ecamsule” also generally refers to water soluble and oil soluble forms of the compound or salts thereof. Further, any reference to ecamsule in this disclosure should not be understood to be limited only to the pure form of ecamsule. All references to ecamsule, include other chemical variations of ecamsule, for example, salts thereof. Sometimes, ecamsule is manufactured or sold as a salt, for example, as ecamsule disodium, or sold as a water soluble or oil soluble form, example mexoryl sx or xl. It is the intention of this disclosure to cover all such variations of ecamsule as one skilled in the art would be skilled in using for compositions containing ecamsule.

[0022] The skincare compositions described herein can comprise at least one melanin reducing agent. Examples of melanin reducing agents include, but are not limited to, at least one of alpha arbutin, kojic acid, mulberry extract, vitamin C, niacinamide, licorice root extract, azelaic acid, ellagic acid, gentisic acid, or thiamidol.

[0023] The skincare compositions described herein can comprise at least one of a skin bleaching agent, including but not limited to, arbutin, hydroquinone, kojic acid, ascorbic acid, magnesium ascorbyl phosphate, and ascorbyl glucosamine. The composition may contain at least one melanocyte reducing agent, such as hydroquinone. Currently, hydroquinone is approved by the FDA at a very low percent compositions.

[0024] The skincare compositions described herein can comprise at least one skin brightening agent that decreases hyperpigmentation, including but not limited to, at least one of retinol (Vitamin A), gentisic acid, ellagic acid, tamarix, mequinol, soy, hydroxystilbene, glutathione, alosein, glycolic acid, melatonin, fluocinolone acetonide, gigawhite, creatin, sodium ascorbyl phosphate, bearberry extract, lemon juice extract, magnesium asorbyl phosphate, glucosamine, and allicin.

[0025] The skincare compositions described herein can comprise at least one additional ingredient such as at least one of water, a cleaning agent, skin conditioning agent, perfume, pigment, moisturizer, film former, make-up agent, detergent, pharmaceutical, emulsifier, humectant, emollient, antiseptic agent, deodorant active, dermatologically acceptable carrier, surfactant, abrasive, absorbent, fragrance, coloring / colorant, essential oil, skin sensate, astringent, anti-acne agent, anti-caking agent, antifoaming agent, antimicrobial, antioxidant, binder, biological additive, enzyme, enzyme inhibitor, enzyme activator, coenzyme, botanical extract, ceramide, buffering agent, bulking agent, chelating agent, cosmetic biocide, denaturant drug astringent, external analgesic, polymer, quat, substantivity increasing agent, opacifying agent, pH adjuster, propellant, reducing agent, sequestrant, skin lightening agent, skin-conditioning agent, skin soothing agent, skin healing agent, aloe vera, pantothenic acid and derivative thereof, allantoin, bisabolol, dipotassium glycyrrhizinate, skin treating agent, thickener, and a vitamin or derivative thereof.

[0026] The skincare compositions described herein can comprise a skin coloring agent, including but not limited to, at least one of a liquid foundation and a concealer.

[0027] The skincare compositions described herein can comprise at least one anti-aging agent, such as ceramides, collagen, glycolic acid, lactic acid, hyaluronic acid, jojoba oil, niacinamide, retinol, and vitamin C.

[0028] The skincare compositions described herein can comprise at least one water-resistant carrier such as hydrogenated vegetable oil, wax, petrolatum, fatty acid ester of glycerol, a fatty acid ester of polyglycerol, a fatty acid ester of a sugar alcohol, and a fatty acid ester of polyethylene glycol.

[0029] The terms “salt” and “salts” refers to the relatively non-toxic, inorganic and organic acid addition salts of the compound(s). These salts can be prepared in situ during the final isolation and purification of the compound(s), or by separately reacting a purified compound(s) in its free base form with a suitable organic or inorganic acid, and isolating the salt thus formed. Representative salts include the hydrobromide, hydrochloride, sulfate, bisulfate, phosphate, nitrate, acetate, valerate, oleate, palmitate, stearate, laurate, benzoate, lactate, phosphate, tosylate, citrate, maleate, fumarate, succinate, tartrate, naphthylate, mesylate, glucoheptonate, lactobionate, and laurylsulphonate salts, and the like. See, for example, Berge et al. (1977)“Pharmaceutical Salts”, J. Pharm. Sci. 66:1 -19, which is incorporated by reference herein in its entirety.

[0030] The terms “salt” and “salts” also refers to the relatively non-toxic, salts of compounds containing one or more acidic functional groups (for example, ecamsule comprises two acidic sulfonic acid groups) and, thus, can form salts with suitable bases. The term “salt” and “salts” in these instances refers to the relatively non-toxic inorganic and organic base addition salts of a compound(s). These salts can likewise be prepared in situ during the final isolation and purification of the compound(s), or by separately reacting the purified compound(s) in its free acid form with a suitable base, such as the hydroxide, carbonate, or bicarbonate of a pharmaceutically acceptable metal cation, with ammonia, or with a pharmaceutically acceptable organic primary, secondary, or tertiary amine. Representative alkali or alkaline earth salts include the lithium, sodium, potassium, calcium, magnesium, and aluminum salts, and the like. Representative organic amines useful for the formation of base addition salts include ethylamine, diethylamine, ethylenediamine, ethanolamine, diethanolamine, piperazine, and the like. See, for example, Berge et al., supra.

[0031] Values expressed in a range format should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or subranges encompassed within that range as if each numerical value and subrange were explicitly recited. For example, a range of “about 0.1 % to about 5%” or “about 0.1 % to 5%” should be interpreted to include not just about 0.1% to about 5%, but also the individual values (e.g., 1 %, 2%, 3%, and 4%) and the sub-ranges (e.g., 0.1 % to 0.5%, 1.1 % to 2.2%, 3.3% to 4.4%) within the indicated range. The statement “about X to Y” has the same meaning as “about X to about Y,” unless indicated otherwise. Likewise, the statement “about X, Y, or about Z” has the same meaning as “about X, about Y, or about Z,” unless indicated otherwise.

[0032] In this document, the terms “a,” “an,” or “the” are used to include one or more than one unless the context clearly dictates otherwise. The term “or” is used to refer to a nonexclusive “or” unless otherwise indicated. In addition, it is to be understood that the phraseology or terminology employed herein, and not otherwise defined, is for the purpose of description only and not of limitation. Any use of section headings is intended to aid reading of the document and is not to be interpreted as limiting. Further, information that isrelevant to a section heading can occur within or outside of that particular section. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0033] In the methods described herein, the steps can be carried out in any order without departing from the principles of the invention, except when a temporal or operational sequence is explicitly recited. Furthermore, specified steps can be carried out concurrently unless explicit claim language recites that they be carried out separately. For example, a claimed step of doing X and a claimed step of doing Y can be conducted simultaneously within a single operation, and the resulting process will fall within the literal scope of the claimed process.

[0034] The term “about” as used herein can allow for a degree of variability in a value or range, for example, within 10%, within 5%, or within 1 % of a stated value or of a stated limit of a range.

[0035] The term “substantially” as used herein refers to a majority of, or mostly, as in at least about 50%, 60%, 70%, 80%, 90%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, 99.99%, or at least about 99.999% or more.

[0036] The term “substantially no” as used herein refers to less than about 30%, 25%, 20%, 15%, 10%, 5%, 3%, 2%, 1 %, 0.5%, 0.1%, 0.05%, 0.001 %, or at less than about 0.0005% or less or about 0% or 0%.

[0037] Those skilled in the art will appreciate that many modifications to the embodiments described herein are possible without departing from the spirit and scope of the present disclosure. Thus, the description is not intended and should not be construed to be limited to the examples given but should be granted the full breadth of protection afforded by the appended claims and equivalents thereto. In addition, it is possible to use some of the features of the present disclosure without the corresponding use of other features. Accordingly, the foregoing description of or illustrative embodiments is provided for the purpose of illustrating the principles of the present disclosure and not in limitation thereof and can include modification thereto and permutations thereof.Examples

[0038] The disclosure can be better understood by reference to the following examples which are offered by way of illustration. The disclosure is not limited to the examples given herein.Example 1

[0039] A composition comprising ecamsule only, such as up to 5% ecamsule, can be prepared, where the composition is available in a face formulation and body formulation, as a liquid lotion or spray.

[0040] In one formulation, an -5% tanscreen composition was made. The tanscreen was prepared by adding ~3526mg of ecamsule disodium (e.g., purchased from medchemexpress.com), and adding it to 5ml of water to dissolve the ecamsule. Then this 5ml of ecamsule was added to 1 / 4 cup of a wholesale lotion (e.g., purchased from wholesalenaturalbodycare.com), weighing ~62grams for 1 / 4 cup of lotion. This wholesale lotion also contained arbutin and kojic acid. In some recipes, depending on the final pH, one may further need to balance the pH in order to reduce any harmful acidic levels for skin.

[0041] In yet another formulation, a tanscreen was made at a lower ecamsule concentration of ~ .75%. This tanscreen as made by adding 500mg of ecamsule (from medchemexpress.com) to 5ml of water and 1 / 4 cup of lotion (from wholesalenautralybodycare.com).

[0042] The tanscreen at -.79% ecamsule was then applied to 5-10 subjects for testing efficacy. A 1 -2 inch circle was drawn on a lightest are of the subjects’ body, e.g., the leg or arm. Sufficient tanscreen was applied to cover the circled area. The subjects were then exposed to 2 hours or more of sunlight, per day for one week. The sunlight was usually natural, however in some cases, an ultraviolet lamp was used as required. The tanscreen was reapplied every 24 hrs to the circled area.

[0043] A photo was taken every day and findings recorded. The findings established a visibly significant reduction in tanning or darkening of the skin of the ‘encircled’ area. This result was found at even the relatively low concentration of ecamsule of - .8%.

[0044] The lotion or ecamsule can be purchased any number of vendors or manufactured as desirable without deviating from the innovative principles of the claimed compositions. The tanscreen can be made in varying ecamsule concentrations (w / w) to maximize efficacy of the tanscreen.Example 2

[0045] A composition comprising ecamsule, such as up to 10% ecamsule (w / w), and one or more melanin decreasing agents (for example vitamin C, kojic acid, retinol, niacinamide, azelaic acid, and mendelic acid, licorice root extract) can be prepared, where the composition is available in a face formulation and body formulation.

[0046] Such a -10% ecamsule tanscreen can be prepared by adding ~7052mg of ecamsule disodium (e.g., purchased from medchemexpress.com), and adding it to 5ml of water to dissolve the ecamsule. Then adding the resulting 5ml of ecamsule to 1 / 4 cup of a wholesale lotion (e.g., purchased from wholesalenaturalbodycare.com), weighing the ~62grams for 1 / 4 cup of the lotion. The final ecamsule is under 10%.Example 3

[0047] A composition comprising ecamsule, such as up to 10% ecamsule, and one or more melanin decreasing agents (for example vitamin C, kojic acid, retinol, niacinamide, azelaic acid, and mendelic acid, licorice root extract), and one or more bleaching agents (for example arbutin or hydroquinone) can be prepared, where the composition is available in a face formulation and body formulation.

[0048] Such a composition can be prepared by combining 95 mL of Wholesale Natural Body Care Alpha Arbutin and Kojic Brightening Moisturizer and 5 mL of ecamsule, without the inclusion of broad spectrum UVB protecting agents / compounds, while ensuring a 5% ecamsule concentration w / w.Example 4

[0049] The compositions of Examples 1 -3, including one or more agents that decrease hyperpigmentation (for example, retinol (Vitamin A) which increases cell turnover, gentisic acid, ellagic acid, Chinese tamarisk, mequinol, soy, hydroxystilbene, glutathione, alosein, glycolic acid, n-acetyl glucosamine, melatonin, fluocinolone acetonide).Example 5

[0050] The compositions of Examples 1 -4 can also be prepared to include tinting for concealer purposes.

[0051] The compositions of Examples 1 -5 will not only fill a gap in the market, but additionally, they will serve as a basis for the research that is needed in this field. Currently, research is not being conducted with the needs of people of color in mind. People of color are having to put harmful chemicals on their bodies without necessary reason to do so.

[0052] The compositions of Examples 1 -5 will be evaluated by using a spectrophotometer to evaluate that those compositions substantially prevent tanning or darkening of the skin of people of color that results from sun exposure. Such evaluations can be performed according to methods known in the art, including the method described in https: / / www.imaging.org / site / PDFS / Reporter / Articles / 2016_31 / REP31_1_20 15CIC_WANG_PG230.pdf , which is incorporated by reference as if fully set forth herein.

[0053] The above reference discloses cheek color measurements, as measured by a TSR spectrascan PR650, to be in the range of 1 .04 to 2.30 MCDM values, for Caucasian to African subjects. MCDM values measured using a Konica Minolta CM700d spectrophotometer, provided a range of cheek color MCDM values of .42 to .23, again going from Caucasian to African subjects. The above values will serve as the ‘baseline’ CIELAB values for subjects in future research.

[0054] As such, for various embodiments of the disclosed tanscreen compositions, the targeted brown population falls between one of these two ranges. When using a spectrascan PR650, we will aim to prepare tanscreens in the claimed ranges, providing efficacy, where the deviation from “baseline” CIELAB / MCDM values will be within or under .1 from the baseline of said subject.

[0055] Using the CM700d spectrophotometer, we will aim for deviations near or under .01 from the baseline .23 measurements provided in the reference.

[0056] The ecamsule used to make the compositions described in this disclosure, including to make the compositions described in Examples 1 -5, can be neutralized in order to be used without substantially offsetting the final pH of the tanscreen. The neutralization can be accomplished by using any suitable base, including an amine base such as triethanolamine.Example 6Methodology

[0057] Four volunteers were asked to sit in the sun for one hour anytime from 10 am-2 pm, for seven days, after applying a lotion described in this Example anywhere on their body that was not exposed to the sun on a regular basis. The amount of lotion was just enough to cover the area and be absorbed as regular lotion application. The lotion was applied daily.

[0058] The lotion applied to the volunteers’ body contained Kojic acid, papaya extract, licorice root extract, B3, turmeric, vitamin B3, alpha arbutin,and ecamsule disodium at 3.2% by weight of entire mixture. Photos were taken every day before and after the starting of their one hour.Results

[0059] Two volunteers were asked to stop the study at four days because the area that did not have the lotion was becoming erythematous (red) and it was thought this may be due to sunburn. The other two volunteers continued the study for all seven days. The photos of all four volunteers, taken after seven days, clearly and visibly showed no substantial hyperpigmentation (tanning) in the area that the mixture was applied. The efficacy of preventing hyperpigmentation, with daily application of the example lotion was evident even with visual inspection.

[0060] Interestingly, even for the two volunteers that had stopped applying the lotion after four days, the photos taken on the seventh day, showed no tanning on the areas where the lotion was applied, nor any sunburn on that area. Photos of the four volunteers (“patients,” abbreviated “Pt ,” 1 -4) are shown in FIG. 1 .Example 7

[0061] Banana Boat® Sport Ultra Lotion, SPF 50, Coppertone® Sport Mineral, SPF 50, Supergoop® Play Everyday Lotion, SPF 50, and a lotion prepared according to the methods described herein were applied to a user’s arm as shown in FIG. 2, wherein the region on the user’s arm to which Banana Boat® Sport Ultra Lotion, SPF 50 is labeled “1 Coppertone® Sport Mineral, SPF 50, is labeled “2”; Supergoop® Play Everyday Lotion, SPF 50, is labeled “3”; normal skin to which nothing has been applied is labeled “NML”; and a lotion prepared according to the methods described herein is labeled “Mine.”

[0062] The region on the user’s arm to which Banana Boat® Sport Ultra Lotion, SPF 50 (1 ) and Supergoop® Play Everyday Lotion, SPF 50 (3) have been applied both look shiny. The region on the user’s arm to which Coppertone® Sport Mineral, SPF 50 (2) has been applied gives the skin a “ghostly” or “white” appearance. In stark contrast, the region on the user’s arm to which a lotion prepared according to the methods described herein was applied looks identical to the region on the user’s arm to which nothing has been applied. The results from this simple experiment demonstrate that the compositions described herein blend in naturally, do not look “ghostly,” and do not look shiny when applied to a user’s darker skin.Example 8

[0063] Body lotions / sunscreens were applied to two users’ skin, one to a user’s legs (FIG. 3) and one to a user’s back (FIG. 4). Supergoop® Play Everyday Lotion, SPF 50 was applied to the legs of the user shown in FIG.3. Eucerin® Daily Hydration Lotion, SPF 15, was applied to the back of the user shown in FIG. 4. Each user was sat in the sun for one hour on each of three consecutive days. There was a four-hour time lag from application to sitting in the sun. Each user’s skin tanned (i.e., their skin became darker) in the areas where the sunscreen and lotion were applied, due to the time lag since the application of the sunscreen. It was determined that neither product protects against tanning, after 4 or more hours. This is because most sunscreens require application at least every 4 hours or less to be effective.

[0064] The following numbered statements are provided to further describe the scope of the disclosure:

[0065] 1 . A tanscreen composition comprising: at least one melanin reducing agent; and less than about 8% ecamsule by weight or a salt thereof of the composition; and at least one additional ingredient; wherein the ecamsule is the sole ultraviolet protecting compound.

[0066] 2. A tanscreen composition comprising:(i) less than about 5% ecamsule by weight or a salt thereof of the composition, or(ii) at least about 5% ecamsule by weight or a salt thereof of the composition; and at least one additional ingredient; wherein the composition does not comprise any additional broad spectrum ultraviolet light protecting agent.

[0067] 3. The tanscreen composition of Statement 1 or 2, wherein the ecamsule is water soluble or oil soluble.

[0068] 4. The tanscreen composition of any of Statements 1 -3, further comprising at least one melanin reducing agent, wherein the at least one melanin reducing agent is at least one of alpha arbutin, kojic acid, mulberry extract, vitamin C, niacinamide, licorice root extract, azelaic acid, ellagic acid, gentisic acid, thiamidol and hydroquinone.

[0069] 6. The tanscreen composition of any of Statements 1 -4, further comprising at least one of a skin bleaching agent and a melanocyte reducingagent which is at least one of arbutin, hydroquinone, kojic acid, ascorbic acid, magnesium ascorbyl phosphate, and ascorbyl glucosamine.

[0070] 7. The tanscreen composition of any of Statements 1 -6, further comprising at least one skin brightening agent that decreases hyperpigmentation which is at least one of retinol (Vitamin A), gentisic acid, ellagic acid, tamarix, mequinol, soy, hydroxystilbene, glutathione, alosein, glycolic acid, melatonin, fluocinolone acetonide, gigawhite, creatin, sodium ascorbyl phosphate, bearberry extract, lemon juice extract, magnesium asorbyl phosphate, glucosamine, and allicin.

[0071] 8. The tanscreen composition of any of Statements 1 -7, wherein the at least one additional ingredient is at least one of water, a cleaning agent, skin conditioning agent, perfume, pigment, moisturizer, film former, make-up agent, detergent, pharmaceutical, emulsifier, humectant, emollient, antiseptic agent, deodorant active, dermatologically acceptable carrier, surfactant, abrasive, absorbent, fragrance, coloring / colorant, essential oil, skin sensate, astringent, anti-acne agent, anti-caking agent, antifoaming agent, antimicrobial, antioxidant, binder, biological additive, enzyme, enzyme inhibitor, enzyme activator, coenzyme, botanical extract, ceramide, buffering agent, bulking agent, chelating agent, cosmetic biocide, denaturant drug astringent, external analgesic, polymer, quat, substantivity increasing agent, opacifying agent, pH adjuster, propellant, reducing agent, sequestrant, skin lightening agent, skin-conditioning agent, skin soothing agent, skin healing agent, aloe vera, pantothenic acid and derivative thereof, allantoin, bisabolol, dipotassium glycyrrhizinate, skin treating agent, thickener, and a vitamin or derivative thereof.

[0072] 9. The tanscreen composition of any of Statements 1 -8, further comprising a skin coloring agent which is at least one of a liquid foundation and a concealer.

[0073] 10. The tanscreen composition of any of Statements 1 -9, further comprising at least one anti-aging agent.

[0074] 1 1 . The composition of any of Statements 1 -10, further comprising at least one water-resistant carrier.

[0075]

[0076] 12. The tanscreen composition of any of Statements 1 -11 , wherein the composition is in a spray form.

[0077] 13. A method for substantially avoiding tanning or darkening of the skin of a person of color, the tanning or darkening of the skin resulting fromsun exposure of the skin of the person of color, the method comprising applying an amount of a tanscreen composition of any preceding Statement to the skin of a person of color effective to substantially avoid tanning or darkening of the skin, wherein deviation from the person’s baseline CIELAB or MCDM value is no more than 0.1 after application of the tanscreen composition at an interval of at least every 24 hours.

Claims

AMENDED CLAIMS received by the International Bureau on 12 April 2023 (12.04.2023)What is claimed is:

1. A tanscreen composition comprising: at least one melanin reducing agent; and less than about 8% ecamsule by weight or a salt thereof of the composition; and at least one additional ingredient; wherein: the ecamsule is the sole ultraviolet protecting compound; and the composition is not a sunscreen.

2. A tanscreen composition comprising:(I) less than about 5% ecamsule by weight or a salt thereof of the composition, or(ii) at least about 5% ecamsule by weight or a salt thereof of the composition: and at least one additional ingredient; wherein: the composition does not comprise any additional broad spectrum ultraviolet light protecting agent; and the composition is not a sunscreen.

3. The tanscreen composition of claim 1 , wherein the ecamsule is water soluble or oil soluble.

4. The tanscreen composition of claim 2, wherein the ecamsule is water soluble or oil soluble.

5. The tanscreen composition of claim 2, further comprising at least one melanin reducing agent, wherein the at least one melanin reducing agent is at least one of alpha arbutin, kojic acid, mulberry extract, vitamin C, niacinamide, licorice root extract, azelaic acid, ellagic acid, gentisic acid, thiamidol and hydroquinone.

6. The tanscreen composition of claim 1 , further comprising at least one of a skin bleaching agent and a melanocyte reducing agent which is at least one of arbutin, hydroquinone, kojic acid, ascorbic acid, magnesium ascorbyi phosphate, and ascorbyi glucosamine.

7. The tanscreen composition of claim 2, further comprising at least one of a skin bleaching agent and a melanocyte reducing agent which is at least one of arbutin, hydroquinone, kojic acid, ascorbic acid, magnesium ascorbyi phosphate, and ascorbyi glucosamine.

8. The tanscreen composition of claim 1 , further comprising at least one skin brightening agent that decreases hyperpigmentation which is at least one of retinol (Vitamin A), gentisic acid, ellagic acid, tamarix, mequinol, soy, hydroxystilbene, glutathione, aiosein, glycolic acid, melatonin, fluocinolone acetonide, gigawhite, creatin, sodium ascorbyi phosphate, bearberry extract, lemon juice extract, magnesium asorbyl phosphate, glucosamine, and allicin.

9. The tanscreen composition of claim 2, further comprising at least one skin brightening agent that decreases hyperpigmentation which is at least one of retinol (Vitamin A), gentisic acid, ellagic acid, tamarix, mequinol, soy, hydroxystilbene, glutathione, aiosein, glycolic acid, melatonin, fluocinolone acetonide, gigawhite, creatin, sodium ascorbyi phosphate, bearberry extract, lemon juice extract, magnesium asorbyl phosphate, glucosamine, and allicin.

10. The tanscreen compositions of claim 1 , wherein the at least one additional ingredient is at least one of water, a cleaning agent, skin conditioning agent, perfume, pigment, moisturizer, film former, make-up agent, detergent, pharmaceutical, emulsifier, humectant, emollient, antiseptic agent, deodorant active, dermatologically acceptable carrier, surfactant, abrasive, absorbent, fragrance, coloring / colorant, essential oil, skin sensate, astringent, anti-acne agent, anti-caking agent, antifoaming agent, antimicrobial, antioxidant, binder, biological additive, enzyme, enzyme inhibitor, enzyme activator, coenzyme, botanical extract, ceramide, buffering agent, bulking agent, chelating agent, cosmetic biocide, denaturant drugastringent, external analgesic, polymer, quat, substantivity increasing agent, opacifying agent, pH adjuster, propellant, reducing agent, sequestrant, skin lightening agent, skimconditioning agent, skin soothing agent, skin healing agent, aloe vera, pantothenic acid and derivative thereof, allantoin, bisaboloi, dipotassium giycyrrhizinate, skin treating agent, thickener, and a vitamin or derivative thereof.

11. The tanscreen compositions of claim 2, wherein the at least one additional ingredient is at least one of water, a cleaning agent, skin conditioning agent, perfume, pigment, moisturizer, film former, make-up agent, detergent, pharmaceutical, emulsifier, humectant, emollient, antiseptic agent, deodorant active, dermatologically acceptable carrier, surfactant, abrasive, absorbent, fragrance, coloring / coiorant, essential oil, skin sensate, astringent, anti-acne agent, anti-caking agent, antifoaming agent, antimicrobial, antioxidant, binder, biological additive, enzyme, enzyme inhibitor, enzyme activator, coenzyme, botanical extract, ceramide, buffering agent, bulking agent, chelating agent, cosmetic biocide, denaturant drug astringent, external analgesic, polymer, quat, substantivity increasing agent, opacifying agent, pH adjuster, propellant, reducing agent, sequestrant, skin lightening agent, skin-conditioning agent, skin soothing agent, skin healing agent, aloe vera, pantothenic acid and derivative thereof, allantoin, bisaboloi, dipotassium giycyrrhizinate, skin treating agent, thickener, and a vitamin or derivative thereof.

12. The tanscreen composition of claim 1 , further comprising a skin coloring agent which is at least one of a liquid foundation and a concealer.

13. The tanscreen composition of claim 2, further comprising a skin coloring agent which is at least one of a liquid foundation and a concealer.

14. The tanscreen composition of claim 1 , further comprising at least one anti-aging agent.

15. The tanscreen composition of claim 2, further comprising at least one anti-aging agent.

16. The tanscreen composition of claim 1 , further comprising at least one water-resistant carrier.

17. The tanscreen composition of claim 2, further comprising at least one water-resistant carrier.

18. The tanscreen composition of claim 1 , wherein the tanscreen composition is in a spray form.

19. The tanscreen composition of claim 2, wherein The tanscreen composition is in a spray form.

20. A method for substantially avoiding tanning or darkening of the skin of a person of color, the tanning or darkening of the skin resulting from sun exposure of the skin of the person of color, the method comprising applying an amount of a tanscreen composition of claim 1 to the skin of a person of color effective to substantially avoid tanning or darkening of the skin, wherein deviation from the person’s baseline CI ELAB or MCDM value is no more than 0.1 after application of the tanscreen at an interval of at least every 24 hours.

21. A tanscreen composition comprising: less than about 8% ecamsule by weight or a salt thereof of the composition; and at least one additional ingredient; wherein: the ecamsule is the sole ultraviolet protecting compound; the composition does not comprise a melanin reducing agent: and the composition is not a sunscreen.

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