Water-resistant and / or photoprotective compositions comprising non-solubilized micronized waxes

Abstract

To provide water-resistant and / or photoprotective compositions comprising non-solubilized micronized waxes.SOLUTION: Provided are water-resistant and / or photoprotective compositions including: (a) an aqueous phase including 0-99.9 wt.% of the composition, based on the total weight of the composition; (b) an oil phase including 0-99.9 wt.% of the composition, based on the total weight of the composition; (c) an active sun block agent; and (d) a micronized, non-solubilized wax including 0.1-10 wt.% of the composition, based on the total weight of the composition; where the wax has a D50 particle size of 1 to 100 μm, and a melting point of at least 70°C; and where the composition includes at least 50 wt.% of at least one of the aqueous phase or the oil phase. Uses of the compositions, and methods utilizing the compositions, are also provided.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The disclosed technology relates to novel cosmetic / dermatological compositions, e.g., for topical application, for ultraviolet (UV) photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of UV radiation, such as solar radiation. For example, the disclosed technology relates to novel water-resistant and improved sun protection factor (SPF) sunscreen formulations containing non-solubilized micronized waxes, such as natural waxes, e.g., carnauba wax, rice bran wax, sunflower wax, castor wax, or combinations thereof. [Background technology]

[0002] UV radiation, consisting of light wavelengths between 10 and 400 nm, is classified into three major subtypes (according to the International Organization for Standardization's ISO-21348 standard): UVA (315-400 nm), UVB (280-315 nm), and UVC (100-280 nm). While UVA and UVB rays penetrate the atmosphere, all UVC rays and some UVB rays are absorbed by the Earth's ozone layer. Therefore, most UV rays that humans come into contact with are UVA, with small amounts of UVB. UVB radiation can cause erythema and burning of the skin and impair the development of natural tans, so such UVB radiation must be shielded from the skin. UVA radiation, which tans the skin, also has adverse effects on the skin, especially in sensitive skin or skin that is continuously exposed to such radiation. UVA radiation, in particular, can cause loss of skin elasticity and the appearance of wrinkles, accelerating premature aging. Such radiation may promote the induction of an erythema reaction or may even enhance this reaction in certain individuals and may even cause phototoxic or photoallergic reactions. Therefore, it is desirable to also block UVA radiation.

[0003] A wide variety of cosmetic compositions have been developed for the purpose of UVA and / or UVB photoprotection of human skin. These photoprotective compositions (sometimes called sunscreen compositions) are often oil-in-water emulsions (i.e., a cosmetically acceptable vehicle, carrier, or diluent containing an aqueous continuous dispersed phase and an oily discontinuous dispersed phase). These compositions contain various concentrations of one or more standard lipophilic and / or hydrophilic organic sunscreen compounds capable of selectively absorbing harmful or damaging UV radiation. These compounds, and the amounts thereof, are selected as a function of the desired sun protection factor, which is mathematically expressed as the ratio of the exposure time required to achieve the erythema threshold with the UV filter to the time required to achieve the erythema threshold in the absence of the UV filter.

[0004] Because sunscreen agents are typically used during activities involving water, there is an increasing demand for higher SPF sunscreen products that use as few active UV filters as possible, but also have high water resistance.However, this is difficult because high SPF sunscreen compositions contain high levels of sunscreen active agents, which can result in negative or undesirable effects on the product, such as poor water resistance, greasiness, stickiness, and / or tackiness.In addition, because certain UV filters can be absorbed into skin or other substrates and cause damage, it may be desirable to include in sunscreen compositions a component that prevents UV filters from being absorbed into substrates without reducing SPF.Therefore, there remains a need for sunscreen compositions that have high photoprotection performance (e.g., high SPF value), sufficient water resistance at the minimum sunscreen concentration for a better sensory profile, and / or enhanced safety.

[0005] Thus, the disclosed technology provides compositions with improved SPF and / or water resistance by incorporating micronized non-meltable waxes into the compositions. Summary of the Invention [Means for solving the problem]

[0006] The presently disclosed subject matter provides a waterproof and / or photoprotective composition comprising: an aqueous phase, comprising 0% to 99.9% by weight of the composition based on the total weight of the composition; an oil phase, comprising 0% to 99.9% by weight of the composition based on the total weight of the composition; an active sunscreen; and a micronized non-solubilized wax, comprising 0.1% to 10% by weight of the composition based on the total weight of the composition, wherein the wax has a melting point of at least 70°C, and the composition comprises at least 50% by weight (e.g., 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% by weight) of at least one of an aqueous phase or an oil phase. By "aqueous phase," it is meant that the phase may comprise water and / or alcohol, and optionally at least one humectant as a diluent for the phase.

[0007] In certain embodiments, the wax has a D50 particle size of 1 to 100 μm. In certain embodiments, the wax has a D50 particle size of 1 to 50 μm. In certain embodiments, the wax has a D50 particle size of 1 to 20 μm. In certain embodiments, the wax has a D50 particle size of 1 to 10 μm. In certain embodiments, the wax has a D50 particle size of 2 to 50 μm. In certain embodiments, the wax has a D50 particle size of 2 to 20 μm. In certain embodiments, the wax has a D50 particle size of 2 to 10 μm. In certain embodiments, the wax has a D50 particle size of 0.5 μm (e.g., 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, or 9 μm) to 200 μm (e.g., 175 μm, 150 μm, 125 μm, 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm, 19 μm, 18 μm, 17 μm, 16 μm, 15 μm, 14 μm, 13 μm, 12 μm, 11 μm, or 10 μm). In certain embodiments, the wax has a melting point of 70° C. (e.g., 75° C. or 80° C.) to 100° C. (e.g., 95° C., 90° C., or 85° C.).

[0008] In certain embodiments, the wax has a particle size distribution such that 98% of the particles by weight fall within the range of 0.5 μm (e.g., 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, or 9 μm) to 200 μm (e.g., 175 μm, 150 μm, 125 μm, 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm, 19 μm, 18 μm, 17 μm, 16 μm, 15 μm, 14 μm, 13 μm, 12 μm, 11 μm, or 10 μm). In these embodiments, the particle size distribution may be defined by the D1 and D99 particle size distribution measurements of the wax.

[0009] In certain embodiments, the wax has a particle size distribution such that 96% of the particles by weight fall within the range of 0.5 μm (e.g., 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, or 9 μm) to 200 μm (e.g., 175 μm, 150 μm, 125 μm, 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm, 19 μm, 18 μm, 17 μm, 16 μm, 15 μm, 14 μm, 13 μm, 12 μm, 11 μm, or 10 μm). In these embodiments, the particle size distribution may be defined by D3 and D97 particle size distribution measurements of the wax.

[0010] In certain embodiments, the wax has a particle size of 90% by weight between 0.5 μm (such as 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, or 9 μm) and 200 μm (such as 175 μm, 150 μm, 125 μm, 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm). , 19 μm, 18 μm, 17 μm, 16 μm, 15 μm, 14 μm, 13 μm, 12 μm, 11 μm, or 10 μm, etc. In these embodiments, the particle size distribution may be defined by D5 and D95 ​​particle size distribution measurements of the wax.

[0011] In certain embodiments, the wax has a particle size distribution such that 80% of the particles by weight fall within the range of 0.5 μm (e.g., 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, or 9 μm) to 200 μm (e.g., 175 μm, 150 μm, 125 μm, 100 μm, 90 μm, 80 μm, 70 μm, 60 μm, 50 μm, 45 μm, 40 μm, 35 μm, 30 μm, 25 μm, 20 μm, 19 μm, 18 μm, 17 μm, 16 μm, 15 μm, 14 μm, 13 μm, 12 μm, 11 μm, or 10 μm). In these embodiments, the particle size distribution may be defined by the D10 and D90 particle size distribution measurements of the wax.

[0012] In certain embodiments, the wax comprises 1% to 5% of the composition, based on the total weight of the composition. In certain embodiments, the wax may be present in an amount of 0.1% (e.g., 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, or 1%) to 10% (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, or 2%) by weight of the composition.

[0013] In certain embodiments, the wax comprises a natural wax. In certain embodiments, the wax comprises at least one of beeswax, scale insect wax, wool wax, spermaceti, liquid fish oil, palm tree wax, candelilla wax, retamo wax, flax wax, cotton wax, hemp wax, sugarcane wax, esparto wax, sorghum grain wax, rice bran wax, leaf blade wax, root wax, bark wax, myrica (fruit) wax, cranberry wax, fruit cuticle wax, liquid vegetable wax, floral wax, candelilla wax, bay laurel wax, Japanese (sumac) wax, oryza sativa wax, soy wax, tallow tree wax, carnauba wax, sunflower wax, castor wax, berry wax, or jojoba wax. In certain embodiments, the wax comprises carnauba wax. In certain embodiments, the wax comprises castor wax. In certain embodiments, the wax comprises rice bran wax. In certain embodiments, the wax comprises sunflower wax. In certain embodiments, the composition comprises an emulsion.

[0014] In certain embodiments, the composition further comprises a stabilizing and / or emulsifying component.

[0015] In certain embodiments, the stabilizing and / or emulsifying component is present in the composition in an amount of 0.1 wt.% (such as 0.2 wt.%, 0.3 wt.%, 0.4 wt.%, 0.5 wt.%, 0.6 wt.%, 0.7 wt.%, 0.8 wt.%, 0.9 wt.%, 1 wt.%, 1.5 wt.%, 2 wt.%, 3 wt.%, or 4 wt.%) to 10 wt.% (such as 9 wt.%, 8 wt.%, 7 wt.%, 6 wt.%, or 5 wt.%) based on the total weight of the composition.

[0016] In certain embodiments, the composition comprises a water-in-oil emulsion or an oil-in-water emulsion.

[0017] In certain embodiments, the active sunscreen is dibenzoylmethane, anthranilate, benzophenone, p-aminobenzoic acid, camphor, cinnamate, salicylate, β,β - comprising at least one of diphenylacrylate, triazine, benzimidazole, bis-benzoazolyl, methylene bis-(hydroxyphenylbenzotriazole), polymeric sunscreen, or silicone sunscreen.

[0018] In certain embodiments, the active sunscreen comprises at least one of avobenzone, octocrylene, or oxybenzone octyl salicylate.

[0019] In certain embodiments, the active sunscreen comprises a metal oxide sunscreen, hi certain embodiments, the active sunscreen comprises at least one of titanium dioxide, silicon dioxide, aluminum oxide, zinc oxide, iron oxide, kaolin, talc, phosphate nanomaterials, carbonate nanomaterials, or hydroxyapatite.

[0020] In certain embodiments, the composition may further comprise an artificial tanning agent. In certain embodiments, the artificial tanning agent may comprise dihydroxyacetone. Artificial tanning agents are materials that provide a tanned appearance without exposure to harmful UV rays.

[0021] In certain embodiments, the composition may be formulated as a cream, dispersion, emulsion, gel, ointment, lotion, foam, spray, or tonic.

[0022] Also provided is a topically applicable cosmetic / dermatological sunscreen oil-in-water emulsion composition for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, comprising (a) an active sunscreen agent; and (b) a micronized non-solubilized natural wax, formulated in (c) a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier.

[0023] Also provided is a topically applicable cosmetic / dermatological formulation for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, comprising (a) an active sunscreen agent and (b) a micronized non-solubilized natural wax, formulated in (c) a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier.

[0024] Also provided is a waterproof and / or photoprotective composition comprising an aqueous phase comprising 20% ​​to 80% by weight of the composition, based on the total weight of the composition; an oil phase comprising 5% to 50% by weight of the composition, based on the total weight of the composition, the oil phase comprising an organic active sunscreen; a micronized non-solubilized natural wax comprising 1% to 5% by weight of the composition, based on the total weight of the composition; and a stabilizing and / or emulsifying component comprising 1% to 10% by weight of the composition, based on the total weight of the composition, wherein the wax has a D50 particle size of 2 to 50 μm and a melting point of 70 to 100° C.

[0025] Also provided is a method for reducing the effects of ultraviolet radiation on human skin, scalp, lips, mucous membranes, and / or hair by applying the above-described composition in an amount effective to at least partially reduce the effects of ultraviolet radiation.

[0026] There is also provided the use of the above composition for ultraviolet photoprotection of human skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation.

[0027] There is also provided the use of a micronized non-solubilized wax in a sunscreen composition to improve the aesthetics and / or sun protection factor of the sunscreen composition.

[0028] The following embodiments of the present subject matter are contemplated. 1. A water-resistant and / or photoprotective composition comprising, based on the total weight of the composition, 1. A waterproof and / or photoprotective composition comprising an aqueous phase comprising 0% to 99.9% by weight of the composition, an oil phase comprising 0% to 99.9% by weight of the composition, based on the total weight of the composition, an active sunscreen, and a micronized non-solubilized wax comprising 0.1% to 10% by weight of the composition, based on the total weight of the composition, wherein the wax has a D50 particle size of 1 to 100 μm and a melting point of at least 70° C., and the composition comprises at least 50% by weight of at least one of the aqueous phase or the oil phase. 2. The composition of embodiment 1, wherein the wax has a D50 particle size of 1 to 50 μm. 3. The composition of either embodiment 1 or embodiment 2, wherein the wax has a D50 particle size of 1 to 20 μm. 4. The composition of any one of embodiments 1 to 3, wherein the wax has a D50 particle size of 1 to 10 μm. 5. The composition of either embodiment 1 or embodiment 2, wherein the wax has a D50 particle size of 2 to 50 μm. 6. The composition of any one of embodiments 1 to 3, wherein the wax has a D50 particle size of 2 to 20 μm. 7. The composition of any one of embodiments 1 to 4, wherein the wax has a D50 particle size of 2 to 10 μm. 8. The composition of any one of embodiments 1 to 7, wherein the wax has a melting point of 70 to 100°C. 9. The composition of any one of embodiments 1-8, wherein the wax comprises 1% to 5% of the composition, based on the total weight of the composition. 10. The composition of any one of embodiments 1-9, wherein the wax comprises a natural wax. 11. The composition of any one of embodiments 1-10, wherein the wax comprises at least one of beeswax, scale wax, wool wax, spermaceti, liquid fish oil, palm tree wax, candelilla wax, retamo wax, flax wax, cotton wax, hemp wax, sugarcane wax, esparto wax, sorghum grain wax, rice bran wax, leaf blade wax, wax from roots, wax from bark, myrica (fruit) wax, cranberry wax, fruit cuticle wax, liquid vegetable wax, floral wax, candelilla wax, bay berry wax, Japanese (sumac) wax, oricury wax, soybean wax, tallow tree wax, carnauba wax, sunflower wax, castor wax, berry wax, or jojoba wax. 12. The composition of any one of embodiments 1-11, wherein the wax comprises carnauba wax. 13. The composition of any one of embodiments 1-11, wherein the wax comprises castor wax. 14. The composition of any one of embodiments 1-11, wherein the wax comprises rice bran wax. 15. The composition of any one of embodiments 1-11, wherein the wax comprises sunflower wax. 16. The composition of any one of embodiments 1-15, wherein the composition comprises an emulsion. 17. The composition of any one of embodiments 1-16, wherein the composition further comprises a stabilizing and / or emulsifying component. 18. The composition of embodiment 17, wherein the stabilizing and / or emulsifying component is present in the composition in an amount of 0.1% to 10% by weight, based on the total weight of the composition. 19. The composition of either embodiment 17 or embodiment 18, wherein the composition comprises a water-in-oil emulsion or an oil-in-water emulsion. 20. The active sunscreen is dibenzoylmethane, anthranilate, or benzophenone. , p-aminobenzoic acid, camphor, cinnamate, salicylate, β,β-diphenylacrylate, triazine, benzimidazole, bis-benzazolyl, methylene bis-(hydroxyphenylbenzotriazole), polymeric sunscreen, or silicone sunscreen. 21. The composition of any one of embodiments 1-19, wherein the active sunscreen comprises at least one of avobenzone, octocrylene, or oxybenzone octyl salicylate. 22. The composition of any one of embodiments 1-21, wherein the active sunscreen comprises a metal oxide sunscreen. 23. The composition of any one of embodiments 1-22, wherein the active sunscreen agent comprises at least one of titanium dioxide, silicon dioxide, aluminum oxide, zinc oxide, iron oxide, kaolin, talc, a phosphate nanomaterial, a carbonate nanomaterial, or hydroxyapatite. 24. The composition of any one of embodiments 1-23, wherein the composition further comprises an artificial tanning agent. 25. The composition of embodiment 24, wherein the artificial tanning agent comprises dihydroxyacetone. 26. The composition of any one of embodiments 1-25, formulated as a cream, dispersion, emulsion, gel, ointment, lotion, foam, spray, or tonic. 27. A topically applicable cosmetic / dermatological sunscreen oil-in-water emulsion composition for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, comprising (a) an active sunscreen agent and (b) a micronized non-solubilized natural wax, and (c) formulated in a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier. 28. A topically applicable cosmetic / dermatological formulation for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, comprising (a) an active sunscreen agent and (b) a micronized non-solubilized natural wax, and (c) formulated in a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier. 29. A waterproof and / or photoprotective composition comprising an aqueous phase constituting 20% ​​to 80% by weight of the composition, based on the total weight of the composition; an oil phase constituting 5% to 50% by weight of the composition, based on the total weight of the composition, wherein the oil phase comprises an organic active sunscreen; a micronized non-solubilized natural wax constituting 1% to 5% by weight of the composition, based on the total weight of the composition; and a stabilizing and / or emulsifying component constituting 1% to 10% by weight of the composition, based on the total weight of the composition, wherein the wax has a D50 particle size of 2 to 50 μm and a melting point of 70 to 100°C. 30. A method of reducing the effects of ultraviolet radiation on human skin, scalp, lips, mucous membranes, and / or hair by applying a composition according to any one of embodiments 1 to 29 in an amount effective to at least partially reduce the effects of ultraviolet radiation. 31. Use of a composition according to any one of embodiments 1 to 29 for ultraviolet photoprotection of human skin, scalp, lips, mucous membranes and / or hair against the damaging effects of ultraviolet radiation. 32. Use of a micronized non-solubilized wax in a sunscreen composition to improve the aesthetics and / or sun protection factor of the sunscreen composition. [Brief explanation of the drawings]

[0029] [Figure 1] Illustrates the mechanism of action of organic and inorganic UV filters. [Figure 2] 1 shows exemplary wax particles according to the present disclosure having irregular shapes and sharp edges. [Figure 3] 1 shows an exemplary particle size distribution diagram. DETAILED DESCRIPTION OF THE INVENTION

[0030] Various features and embodiments of the present subject matter are described below by way of non-limiting example.

[0031] The amount of each chemical component described herein is exclusive of any solvent or diluent oil that may normally be present in commercially available materials, i.e., on an active chemical basis, unless otherwise indicated. However, unless otherwise indicated, each chemical or composition referred to herein should be construed as a commercial material, which may contain isomers, by-products, derivatives, and other materials normally understood to be present in commercial products.

[0032] It is known that some of the substances described herein may interact in the final formulation, so the components of the final formulation may differ from those initially added. For example, metal ions (e.g., from detergents) may migrate to other acidic or anionic sites on other molecules. The products formed thereby, including those formed by employing the compositions of the present inventive subject matter in their intended use, may not be easily described. Nevertheless, all such modifications and reaction products are within the scope of the present inventive subject matter, which includes compositions prepared by mixing the components described herein.

[0033] As used herein, the indefinite article "a" is intended to mean one or more. As used herein, the phrase "at least one" means one or more of the following terms. Thus, "a" and "at least one" may be used interchangeably. For example, "at least one of A, B, or C" means that only one of A, B, or C may be included, or in alternative embodiments, any mixture of two or more of A, B, and C may be included. As another example, "at least one X" means that one or more material / component X may be included.

[0034] As used herein, the term "about" means that a given quantity value is within ±20% of the stated value. In other embodiments, values ​​are within ±15% of the stated value. In other embodiments, values ​​are within ±10% of the stated value. In other embodiments, values ​​are within ±5% of the stated value. In other embodiments, values ​​are within ±2.5% of the stated value. In other embodiments, values ​​are within ±1% of the stated value. In other embodiments, values ​​fall within the explicitly recited value range that would be understood by one of ordinary skill in the art, based on the disclosure provided herein, to perform substantially similarly to a composition containing the literal amounts recited herein.

[0035] As used herein, the term "substantially" means that the value of a given quantity is within ±10% of the stated value. In other embodiments, the value is within ±5% of the stated value. In other embodiments, the value is within ±2.5% of the stated value. In other embodiments, the value is within ±1% of the stated value.

[0036] As used herein, the term "substantially free" means that a component does not contain any intentional addition of the material that the component is "substantially free of." For example, a component may contain the material that the component is "substantially free of" at or below impurity levels, which may be the result of an incomplete chemical reaction and / or an unintended / undesired (but perhaps unavoidable) reaction product.

[0037] As used herein, "including," "containing," or "characterized by" are synonyms. The transitional phrase "comprising," as defined herein, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. However, within each "comprising" recitation herein, the term may, as an alternative embodiment, be used in conjunction with "consisting essentially of." The phrases "of" and "consisting of" are also intended to encompass the phrases "of" and "consisting of," where "consisting of" excludes any unspecified element or step, and "consisting essentially of" permits the inclusion of additional unrecited elements or steps that do not materially affect the essential or basic and novel characteristics of the composition or method under consideration.

[0038] As used herein, the phrase "active sunscreen" means any material that provides protection from UV radiation with a sun protection factor of greater than or equal to 2. Phrases such as "UV filter," "UV blocker," "UV absorber," "UV photoprotector," "sunscreen," and the like are used synonymously with the phrase "active sunscreen" and should not be construed as limiting to any particular type of sunscreen unless expressly stated or required by context.

[0039] It has now been surprisingly and unexpectedly determined that by incorporating a non-solubilized micronized wax into a sunscreen composition, the final product formulation, when topically applied to the skin, scalp, lips, mucous membranes, and / or hair, is characterized by a high SPF value and excellent water resistance, for example, when compared with the same formulation that does not contain the micronized wax.It has also been unexpectedly and surprisingly determined that the addition of the micronized non-solubilized wax increases the in vitro SPF and water resistance of the sunscreen composition.

[0040] More specifically, according to the subject matter of the present invention, water-resistant and photoprotective sunscreen formulations exhibiting enhanced SPF can be provided by incorporating non-solubilized micronized natural waxes therein, such as carnauba wax and / or rice bran wax.Previously, the SPF of sunscreen products in certain compositions has been improved by using solubilized waxes, so this phenomenon was unexpected.However, unexpectedly, it has been discovered that non-solubilized (natural) micronized waxes not only increase the SPF value of sunscreen compositions, but also improve the water resistance of the formulations.

[0041] The micronized waxes of the present subject matter can be non-solubilized micronized natural waxes having irregular particle shapes prepared using air jet milling or hot air spraying methods. The D50 particle size of the waxes of interest can range up to 100 μm, but desirably can be about 2-50 μm as measured using laser diffraction.

[0042] The shape of wax particles can be spherical, elliptical, oblong, irregular, or may lack a specific shape and / or have sharp edges. As used herein, the terms "spherical," "elliptical," or "oblong" also mean that the wax particles have a uniform, substantially spherical, elliptical, or oblong shape. As used herein, the term "irregular" means that the wax particles have no specific shape and cannot be characterized as spherical, elliptical, or oblong. The term "sharp edges" means that the wax particles have a geometric shape with internal angles of less than 90° or less than 45°, as shown in Figure 2. When used in the context of spherical particle shape, the term "substantially" means that the particle is of substantially isotropic shape, i.e., it has a relatively regular morphology. As used herein, the term "particle size" refers to the volume-equivalent diameter of a single particle. In other words, the diameter of an irregular particle is reported as the diameter of a sphere having a volume equal to the volume of the irregular particle.

[0043] Waxes may be used in sunscreen compositions in an amount of 0.1% to 10% by weight, for example, 1% to 5% by weight, based on the total weight of the composition. In certain embodiments, waxes may be present in an amount of 0.1% by weight (e.g., 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, or 1%) to 10% by weight (e.g., 9%, 8%, 7%, 6%, 5%, 4%, 3%, or 2%) based on the total weight of the composition.

[0044] "Micronized" means that the wax undergoes a process that produces wax particles in the micron (μm) range in size (approximately 1-1000 μm). Particle size can be adjusted to some extent by modifying processing parameters. Methods for producing micronized wax are known in the art and include:

[0045] Fluidized-bed jet milling and melt spraying are the two most commonly used methods for producing finely divided powders. Interparticle collisions occur when the polymer passes through opposing jets of high-pressure air in a fluidized-bed jet mill, producing a finely divided wax polymer. Controlling the flow rate through the milling chamber and the pressure of the opposing jets allows for the micronization of a wide range of waxy polymers. In-line classifiers are used to adjust and control the resulting particle size distribution to a target range. The melt spraying technique produces fine, spherical wax particles when the molten waxy polymer is sprayed into a cooling chamber. The particles are separated from the gas stream in a cyclone chamber or filter baghouse. Polymers and polymer blends with a wide melting range are typically processed more efficiently and result in narrower particle size distributions when micronized in a fluidized-bed jet mill compared to the melt spraying method.

[0046] Air Jet Mill: Many of the micronized waxes described herein were prepared by the air jet mill process. This process uses high-velocity jets of compressed air or inert gas to collide particles with one another. The jet mills used to prepare these wax products are designed to output particles below a certain size, but continuing to crush particles above that size results in a narrow size distribution of the resulting product. Particles exiting the mill are separated from the gas stream by a rotating classifier wheel integrated into the jet mill's grinding chamber. The final particle size is primarily controlled by the rotational speed of the classifier wheel.

[0047] Hot Melt Spray: Hot melt extrusion is a solventless process that uses heat and pressure to molecularly disperse waxes. Typically, solid particles are first heated above their melting point and then sprayed under pressure into cold air to solidify.

[0048] "Non-solubilized" means that the waxes do not dissolve and / or melt during processing of the compositions / formulations described herein. In other words, the waxes may be melted and / or melted to produce them in micronized form, but then do not melt and / or melt again before or during the production of the compositions described herein.

[0049] "Natural" means that the wax is natural or derived from a natural source, as opposed to synthetic waxes, which may be manufactured by chemical reactions to form (polymeric) waxes.

[0050] Suitable waxes include beeswax, scale wax, wool wax, spermaceti, liquid fish oil, palm tree wax, candelilla wax, retamo wax, flax wax, cotton wax, hemp wax, sugarcane wax, esparto wax, sorghum grain wax, rice bran wax, leaf wax, root wax, and bark wax. Examples of waxes include, but are not limited to, at least one of: laurel, myrica (fruit) wax, cranberry wax, fruit cuticle wax, liquid vegetable wax, floral wax, candelilla wax, bay laurel wax, Japanese (sumac) wax, oricury wax, soybean wax, tallow tree wax, carnauba wax, sunflower wax, castor wax, berry wax, or jojoba wax. In certain embodiments, the wax may include at least one of carnauba wax, rice bran wax, sunflower wax, or castor wax.

[0051] The non-solubilized micronized (natural) waxes of the present disclosure can be heterogeneous, irregular particulates with sharp edges, and the particles can be non-spherical in shape. The particles can be homogeneously distributed throughout the sunscreen formulation. They can be added to the oil phase, the water phase, or post-added to the formulation.

[0052] In certain embodiments, cosmetic / dermatological compositions according to the present disclosure contain (a) an active sunscreen (such as at least one UVA and / or UVB sunscreen) and (b) a non-solubilized micronized natural wax, and (c) may be formulated in a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier therefor.

[0053] "UVA and / or UVB sunscreen" refers to any compound or any combination of compounds that prevents or at least limits contact of UVA and / or UVB radiation with the surface (skin, hair) to which it is applied by known mechanisms of absorption, reflection, and / or scattering of such radiation. Stated differently, these compounds may be UV-absorbing organic screeners or inorganic (nano)pigments, as well as mixtures thereof, that scatter, absorb, and / or reflect UV radiation. In certain embodiments, at least one UVA and / or UVB sunscreen may comprise one or more hydrophilic organic screeners, one or more lipophilic organic screeners, and / or one or more mineral or inorganic (nano)pigments.

[0054] A suitable UV photoprotectant is octocrylene, which has the following chemical formula: [ka]

[0055] Another suitable UV photoprotectant is homosalate, which has the following chemical formula: [ka]

[0056] Another suitable UV photoprotectant is ethylhexyl salicylate, which has the following chemical formula: [ka]

[0057] Another suitable UV photoprotectant is the dibenzoylmethane sunscreen avobenzone, or 4-(tert-butyl)-4-methoxydibenzoylmethane, which has the following chemical formula: [ka]

[0058] Other suitable UV photoprotective agents are metal oxide sunscreens such as zinc oxide and / or titanium oxide.The sunscreens of the present disclosure, which are physical sunscreens, reflect or scatter ultraviolet radiation.Examples of physical sunscreens include red petrolatum, titanium dioxide, zinc oxide, iron oxide, kaolin, ichthammol, red veterinary petrolatum, talc, calamine, phosphate- and carbonate-based nanomaterials, and pure and / or doped hydroxyapatite.

[0059] Chemical absorber sunscreens, such as avobenzone, absorb harmful ultraviolet radiation. Chemical absorbers are classified as UVA or UVB absorbers, depending on the type of radiation they protect against. UVA absorbers generally absorb radiation in the 320-400 nm region of the ultraviolet spectrum. UVA absorbers include anthranilates, benzophenones, and dibenzoylmethanes. UVB absorbers generally absorb radiation in the 280-320 nm region of the ultraviolet spectrum. UVB absorbers include p-aminobenzoic acid derivatives, camphor derivatives, cinnamates, and salicylates.

[0060] Suitable sunscreens may include chemical absorbers, but may also include physical blockers. The mechanism of organic vs. inorganic UV filters is discussed in Manaia, Eloisa Berbel, et al. "Inorganic UV filters." Brazil n Journal of Pharmaceutical Sciences 49.2 (2013):201-209. Active molecules that can act as UV filters are divided into two groups: organic and inorganic. Inorganic UV filters, such as zinc oxide, titanium dioxide, iron oxide, kaolin, ichthammol, red veterinary petrolatum, talc, calamine, phosphate- and carbonate-based nanomaterials, and pure and / or doped hydroxyapatite, scatter, reflect, and / or absorb the sun's potentially harmful UV radiation that reaches the skin. Organic UV filters can be aromatic compounds containing carbonyl groups. Upon receiving the energy of UV photons, organic UV filters can act in three ways: (i) undergo a conformational molecular change, (ii) emit radiation of a higher wavelength, or (iii) release the incident energy as heat. The mechanism of action of organic protector molecules is reversible, allowing the same molecule to function repeatedly. Examples of organic sunscreens are salicylates, cinnamates, benzophenones, anthranilates, dibenzoylmethanes, and p-aminobenzoates. Figure 1 illustrates the mechanism of action of organic and inorganic UV filters.

[0061] Exemplary sunscreens that may be incorporated into the compositions of the present disclosure are chemical absorbers such as p-aminobenzoic acid derivatives, anthranilates, benzophenones, camphor derivatives, cinnamum derivatives, dibenzoylmethane, β,β-diphenylacrylate derivatives, salicylic derivatives, triazine derivatives, benzimidazole compounds, bis-benzazolyl derivatives, methylene bis-(hydroxyphenylbenzotriazole) compounds, sunscreen polymers and / or silicones, or mixtures thereof.

[0062] Exemplary sunscreens that may be incorporated into the compositions of the present disclosure are physical screeners such as cerium oxide, chromium oxide, cobalt oxide, iron oxide, red petrolatum, silicone-treated titanium dioxide, titanium dioxide, zinc oxide, zirconium oxide, or mixtures thereof.

[0063] Suitable sunscreens that are active in the UVA and / or UVB range include one or a combination of the following: p-aminobenzoic acid, Oxyethylene (25 mol) p-aminobenzoate, 2-ethylhexyl p-dimethylaminobenzoate, Ethyl N-oxypropylene p-aminobenzoate, Glycerol p-aminobenzoate, 4-Isopropylbenzyl salicylate, Butyloctyl salicylate and other salicylate-derived UV absorbers, Methoxycrylene, 2-ethylhexyl 4-methoxycinnamate, Methyl diisopropyl cinnamate, Isoamyl 4-methoxycinnamate, Diethanolamine 4-methoxycinnamate, 3-(4'-trimethylammonium)-benzylidene-bornan-2-one methyl sulfate, 2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone-5-sulfonate, 2,4-dihydroxybenzophenone, 2,2',4,4'-tetrahydroxybenzophenone, 2,2'-dihydroxy-4,4'dimethoxybenzophenone, 2-hydroxy-4-n-octoxybenzophenone, 2-hydroxy-4-methoxy-4'-methoxybenzophenone, α-(2-oxoborn-3-ylidene)-tolyl-4-sulfonic acid and its soluble salts, 3-(4'-sulfo)benzylidene-bornan-2-one and its soluble salts, 3-(4'methylbenzylidene)-d,1-camphor, 3-benzylidene-d,1-camphor, benzene 1,4-di(3-methylidene-10-camphosulfonic) acid and its salts (Mexoryl SX, a product described in U.S. Pat. No. 4,585,597, issued April 29, 1986 to Lange et al.); Urocanic acid, 2,4,6-tris[p-(2'-ethylhexyl-1'-oxycarbonyl)-anilino]-1,3,5-triazine, 2-[(p-(tertiobutylamido)anilino]-4,6-bis-[(p-(2'-ethylhexyl-1'-oxycarbonyl)anilino]-1,3,5-triazine, 2,4-bis{[4-(2-ethylhexyloxy)]-2-hydroxy]-phenyl}-6-(4-methoxy-phenyl)-1,3,5-triazine (marketed by Ciba as "TINOSORB S"); tris-biphenyltriazine (and) aqua (and) decyl glucoside (and) butylene glycol (and) disodium phosphate (and) xanthan gum (marketed by BASF as "TINOSORB® A2B"); Polymers of N-(2et4)-[(2-oxoborn-3-ylidene)methyl]benzyl]-acrylamide, 1,4-bisbenzimidazolyl-phenylene-3,3',5,5'-tetrasulfonic acid and its salts, Benzalmalonate-substituted polyorganosiloxane, Benzotriazole-substituted polyorganosiloxane (drometrizole trisiloxane), dispersed 2,2'-methylene-bis-[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol], such as that marketed by Fairmount Chemical under the trademark MIXXIM BB / 100, or micronized in its dispersed form, such as that marketed by Ciba-Geigy under the trademark TINOSORB M; solubilized 2,2'-methylene-bis-[6-(2H-benzotriazol-2-yl)-4-(methyl)phenol], such as that marketed by Fairmount Chemical under the trademark MIXXIM BB / 200; Natural UV absorbers such as Karanja oil or similarly named Pongamia oil, also known as Pongamia pinnata or Pongamia glabra extract or oil, derived from the seeds of the Millesia pinnata tree, Millesia pinnata, · Nature-inspired UV absorbers such as sinapate esters and their derivatives, and Non-regulatory approved synthetic UV absorbers such as butyloctyl salicylate and other salicylate-derived UV absorbers such as methoxycrylene.

[0064] Suitable sunscreens are one of octyl salicylate, octocrylene, and oxybenzone. Dibenzoylmethane derivatives other than avobenzone are also suitable sunscreens according to the present disclosure, including one or a combination of the following: 2-methyldibenzoylmethane, 4-methyldibenzoylmethane, 4-isopropyldibenzoylmethane, 4-tert.-butyldibenzoylmethane, 2,4-dimethyldibenzoylmethane, 2,5-dimethyldibenzoylmethane, 4,4'-diisopropyldibenzoylmethane, 4,4'-dimethoxydibenzoylmethane, 2-methyl-5-isopropyl-4'-methoxydibenzoylmethane, 2-methyl-5-tert.-butyl-4'-methoxydibenzoylmethane, 2,4-dimethyl-4'-methoxydibenzoylmethane, and 2,6-Dimethyl-4-tert.-butyl-4'-methoxydibenzoylmethane.

[0065] The at least one subject UVA and / or UVB sunscreen may be incorporated into the compositions disclosed herein in an amount ranging from about 0.01% to about 10% by weight, e.g., from about 0.1% to about 6% by weight, based on the total weight of the composition. Of course, greater or lesser amounts may be suitable depending on the nature of the particular formulation.

[0066] In certain embodiments, the composition may further comprise an artificial or sunless tanning composition, such as dihydroxyacetone (DHA). A wide variety of artificial tanning agents have been developed. Artificial tanning agents provide the much-desired tanning or darkening response that was previously only achieved through harmful exposure to ultraviolet radiation. DHA, in particular, is widely used in cosmetics to achieve artificial tanning of the skin. Epidermal proteins have very high concentrations of arginine, lysine, and histidine, and the reaction of skin with DHA to produce an artificial tan takes advantage of this fact. The tanning reaction proceeds through the combination of DHA with the free amino groups of skin proteins, particularly the free guanido groups of arginine. Suitable artificial tanning compositions include, but are not limited to, at least one of allose, alpha hydroxy substituted ketones (such as dihydroxyacetone), altrose, arabinose, erythrose, fructose, galactose, glucose, glyceraldehyde, indole, lactose, mannose, lyose, ribose, pentose, sucrose, talose, or xylose.

[0067] The compositions disclosed herein can be formulated into a wide variety of products including creams, dispersions, emulsions (oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone), gels, ointments, lotions, foams, sprays, tonics, and the like.

[0068] The topical cosmetic composition of the present disclosure can contain a carrier (vehicle or diluent) or a mixture of carriers.The carrier must be cosmetically and / or pharmaceutically acceptable, which reflects that the carrier is suitable for topical application to the skin, has good aesthetic properties, is compatible with any other components, and does not cause any adverse safety or toxicity concerns.The carrier and additional components used to formulate such products vary depending on the type of product and can be routinely selected by those skilled in the art.

[0069] The compositions disclosed herein may include a carrier or mixture of carriers suitable for topical application to human skin. The carrier may comprise about 0.5% to about 99.5% by weight of the composition, for example, about 5.0% to about 99.5% by weight, or about 10.0% to about 98.0% by weight, based on the total weight of the composition. As used herein, the phrase "suitable for topical application to human skin" reflects that the carrier does not impair or adversely affect the water resistance of the composition or cause irritation to human skin.

[0070] Carriers suitable for use in the present compositions include those used in the formulation of a wide variety of products including, for example, creams, dispersions, emulsions, gels, lotions, foams, sprays, and tonics.

[0071] Carriers as used herein include a wide range of compositions conventionally used in cosmetic / dermatological compositions. The carrier may contain various additional ingredients. The carrier may contain a solvent for dissolving or dispersing the polymer. The carrier may also contain a variety of additional materials, including but not limited to esters (such as isopropyl myristate), halogenated hydrocarbons (such as Freon), hydrocarbons (such as decene, hexane, and isobutane), linalool, and volatile silicon derivatives (such as siloxanes such as phenylpentamethyldisiloxane, methoxypropylheptamethylcyclotetrasiloxane, chloropropylpentamethyldisiloxane, hydroxypropylpentamethyldisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, cyclomethicone, dimethicone, etc.), and mixtures thereof.

[0072] Foams and aerosol sprays may also contain any conventional propellant for delivering materials as a foam in the case of foams or as a fine, uniform spray in the case of aerosol sprays. Examples of suitable propellants include hydrofluoric acid compounds, dichlorodifluoromethane, difluoroethane, dimethyl ether, isobutane, n-butane, propane, or trichlorofluoromethane. Low-viscosity tonic or spray products may also contain an emulsifier. Examples of suitable emulsifiers are anionic surfactants, cationic surfactants, nonionic surfactants, and mixtures thereof. Fluorosurfactants are particularly suitable when the product is a spray composition and / or when it is a spray composition with a relatively low level of volatile organic solvents, such as alcohol, and a relatively high level of water (i.e., greater than about 10% by weight). When such an emulsifier is included, it may be present at a level of about 0.01% to about 7.5% by weight of the composition. The level of propellant can be adjusted as needed, but is generally from about 3% to about 30% by weight of the foam composition, and from about 15% to about 50% by weight of the aerosol spray composition.

[0073] Suitable spray compositions also include conventional non-aerosol pump sprays, or "atomizers," aerosol containers or canisters having propellants as described above, and pump aerosol containers that utilize compressed air as a propellant.

[0074] A wide variety of additional components may be used in the topical cosmetic / dermatological compositions herein. The compositions disclosed herein may contain a safe and effective amount of pharmaceutical additives or adjuvants. The phrase "safe and effective" refers to an amount of active agent that is high enough to significantly or positively alter the condition being treated, within the scope of sound medical judgment, but low enough (at a reasonable benefit / risk ratio) to avoid serious side effects. A safe and effective amount of a pharmaceutical active agent will vary depending on the specific active species, the ability of the composition to penetrate the active species through the skin, the amount of composition applied, the specific condition being treated, the age and physical condition of the patient being treated, the severity of the condition, the duration of treatment, the nature of any concurrent therapy, and similar factors.

[0075] Suitable pharmaceutically active agents that can be used in the present compositions include antibacterial, antifungal, antiprotozoal, and antiviral agents.Antibacterial agents can include β-lactam drugs, amanfadine, amikacin, capreomycin, chlorhexidine, chlortetracycline, ciprofloxacin, clindamycin, doxycycline, erythromycin, ethambutol, gentamicin, kanamycin, lineomycin, methacycline, methenamine, metronidazole, miconazole, minocycline, neomycin, netilmicin, norfloxacin, oxytetracycline, paramomycin, pentamidine, quinolone drugs, streptomycin, tetracycline, tobramycin, and pharmaceutically acceptable salts of triclosan.

[0076] The subject cosmetic / dermatological compositions, when formulated as emulsions, may contain various emulsifiers. These emulsifiers are useful for emulsifying the various carrier components of the compositions. Suitable emulsifiers may include any of a wide variety of nonionic, cationic, anionic, and zwitterionic emulsifiers known in the art.

[0077] Suitable classes of emulsifiers include acyl lactates, alkyl phosphates, carboxylic acid copolymers, esters and ethers of glucose, esters of glycerin, esters of propylene glycol, esters of sorbitan anhydride, esters of sorbitol, ethoxylated ethers, ethoxylated alcohols, fatty acid amides, fatty acid esters of polyethylene glycol, fatty esters of polypropylene glycol, polyoxyethylene fatty ether phosphates, soaps, and mixtures thereof.

[0078] Suitable emulsifiers may include, but are not limited to, ceteareth-20, ceteth-10, cetyl phosphate, diethanolamine cetyl phosphate, glyceryl stearate, PEG-100 stearate, polyethylene glycol 20 sorbitan monolaurate, polyethylene glycol 5 soy sterol, polysorbate 60, polysorbate 80, potassium cetyl phosphate, PPG-2 methyl glucose ether distearate, steareth-20, and mixtures thereof. Suitable natural emulsifiers may include sucroesters, alkyl polyglycosides, monoglycerol esters, lecithin and its derivatives, or mixtures thereof.

[0079] The target cosmetic / skin composition may also contain various emollients.Suitable examples of emollients include, but are not limited to, natural or naturally derived oils, such as vegetable oils, vegetable triglycerides, vegetable hydrocarbons, highly branched hydrocarbons, non-polar carboxylic acid and alcohol esters, volatile and non-volatile silicone oils, and mixtures thereof.For example, suitable emollients include caprylic / capric triglycerides (CCT) and short-chain C8-C 14 Plant-based hydrocarbons may be mentioned.

[0080] Various additional components may be incorporated into the subject cosmetic / dermatological compositions. Non-limiting examples of these additional components include cationic polymers and thickeners, chelating agents, gums and thickeners, low pH thickeners, polymers for enhancing the film-forming properties and substantivity of the composition, sequestering agents, moisturizing agents, skin penetration aids, suspending agents, vitamins and their derivatives, preservatives, and aesthetic components. Suitable additional components include xanthan gum, diutan gum, guar gum, tara gum, cellulose gum and its derivatives, acrylates / C 10-30 Alkyl acrylates, as well as acrylate-based crosspolymers and polyurethane-based polymers may be included.

[0081] Suitable preservatives that are conventional in the art and that prevent or retard the growth of microorganisms and therefore protect cosmetic products from spoilage are described in the CFTA International Cosmetic Ingredient Dictionary and Handbook, seventh edition, 2, 1654 (1997).

[0082] The cosmetic / dermatological compositions of the present disclosure are administered in a conventional manner to provide the desired benefits. Such methods of use generally involve topically applying an effective amount of the composition to the skin, which can then be left on until absorbed or removed from the skin.

[0083] While the above compositions focus on fully formulated compositions, micronized non-solubilized waxes can also be used in concentrated formulations, which can then be added to other components to produce fully formulated compositions, such as sunscreen compositions. In such concentrated formulations, the micronized non-solubilized wax can be present in an amount of up to 80% by weight (75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, or more), based on the total weight of the concentrated formulation. , 35%, 30%, 25%, 20%, or 15% by weight, etc., with the remainder of the concentrated formulation including a diluent (e.g., oil and / or aqueous diluent) and, optionally, at least one of a dispersant, stabilizer, or thickener. The concentrated formulation may also include an active sunscreen, as well as other ingredients that may be suitable for use in a fully formulated composition as described above. The concentrated formulation may also include other ingredients that may be useful in creating the desired concentrated formulation (rheology modifiers, fillers, etc.) and that will not adversely affect the fully formulated composition to which the concentrate is intended to be added. [Example]

[0084] The subject matter disclosed herein is useful for improving sunscreen compositions, which may be better understood with reference to the following examples, which are provided solely to further illustrate the subject matter disclosed herein, and should not be construed as limiting the subject matter in any way.

[0085] The examples provided below show the average in vitro SPF and water resistance of different sunscreen formulations, and demonstrate the effect of non-solubilized micronized natural waxes in enhancing both properties. As shown below, it was unexpectedly discovered that the micronized form of wax demonstrated a significant improvement in SPF.

[0086] In the examples below, all parts and percentages are by weight unless otherwise indicated.

[0087] In vitro SPF and water resistance measurement techniques The in vitro SPF values ​​of the formulations on PMMA plates were measured using a Labsphere UV-2000S transmittance analyzer. This instrument rapidly measures the diffuse transmittance of sunscreen samples in the ultraviolet wavelength range of 250 to 450 nm. Labsphere's Spectralon® integrating sphere incorporates a re-optimized xenon flash lamp, providing excellent diffuse illumination of the product sample and minimizing data integration time. The UV-2000S software was then used to calculate the UVA / UVB protection factor of the sunscreen according to the US Food and Drug Administration (FDA) method. The critical wavelength was determined using the wavelength at which 90% of the area under the curve was located, starting at 290 nm (CFR - Code of Federal Regulations Title 21).

[0088] The formulations were applied to polymethyl methacrylate (PMMA) sample plates suitable for UV transmittance measurements, purchased from Helioscience. 1.1 mg / cm of each formulation was applied. 2 was applied to the plate. For each formulation, two plates were made, and on each plate, five measurements were taken at different locations. Each measurement is the average of three scans. Overall, therefore, each SPF measurement is the average of 30 scans, providing a representative average of the formulation spread across the PMMA plate and accounting for inconsistencies in film thickness and measurement error. As used herein, "standard deviation" (STD) refers to the STD of all values ​​measured for a particular sample, calculated using the following formula:

number

number

[0089] The accuracy of the test depends on the application of precisely controlled amounts of sunscreen product evenly distributed across the PMMA plate. Each formulation was first applied in a series of small dots across the PMMA plate using a positive displacement micropipette. Then, HelioScreen HD The formulation was spread evenly using a Spreadmaster robot. Each plate was then equilibrated in the dark for 30 minutes before being pre-illuminated.

[0090] Light Stability: The light stability of each formulation was measured under 550 W / m 2 The formulations were evaluated by subjecting them to full spectrum light for 10 minutes at 1000 SPF. The SPF values ​​of the samples were then measured as described above.

[0091] Water Resistance: The water resistance of each formulation was measured by immersing each plate in water at 30°C for 80 minutes under slight turbulence at 115 RPM using a 708-DS dissolution apparatus purchased from Agilent Technologies. Each plate was then removed from the water and allowed to dry and equilibrate in the dark for 30 minutes before measuring the SPF value as described above.

[0092] Particle size analysis The particle size, particle size distribution, and shape of wax particles of interest in this disclosure may be assessed by any known method, such as those described in US2006 / 0292095 A1, such as laser diffraction, ultrasonic extinction (acoustic spectroscopy), optical cross-correlation spectroscopy, particle size distribution measurements, and / or image analysis (optical microscopy).

[0093] A preferred method for measuring particle size is laser diffraction. Laser diffraction uses incident light scattering to measure particle size. A Mastersizer 3000 (Malvern Instruments Limited) laser diffraction instrument was utilized to measure particle size values ​​for certain non-solubilized micronized natural waxes described herein. According to the instrument manufacturer (Malvern Instruments Limited: www.malvern.com), the Mastersizer 3000 uses the technique of laser diffraction to measure particle size. This is done by measuring the intensity of light scattered as a laser beam passes through a dispersed particulate sample. When a beam of light is partially blocked by an obstacle, some of the light scatters around the object, resulting in bright and dark bands often seen at the edges of the shadow; this effect is known as diffraction. These effects can be modeled using the Huygens-Fresnel principle. Huygens hypothesized that every point on a primary wavefront acts as the source of a spherical secondary wavelet, and the sum of these secondary wavelets determines the wave shape at any subsequent time. Fresnel developed equations using Huygens wavelets and the principle of wave superposition, which model these diffraction effects very well. The angle of the laser beam and particle size have an inverse relationship; as particle size decreases, the angle of the laser beam increases, and vice versa. This data is then analyzed using the instrument's software to calculate the particle size that created the scattering pattern. Pure powder or dispersed samples are passed through the measurement area of ​​the optical bench, where the laser beam illuminates the particles. Samples are measured as follows: (i) as solid powders, using the Aero-S accessory for solid samples with a gap of 2.0-4.0 mm, or (ii) in liquid dispersions, using the Hydro SV accessory for liquid samples. For this example, powdered wax was pre-dispersed at 5% in caprylic / capric triglyceride (CCT) containing 2% Matrifuse S-1 and measured before and after melting at 90°C and cooling to 25°C. Measurements were performed using a Hydro SV in caprylic / capric triglyceride (CCT) media at 1000 speed (arbitrary units), adding droplets of sample until the opacity fell within the measurement range. A series of detectors then precisely measures the intensity of light scattered by particles within the sample for both red and blue wavelengths of light and over a wide range of angles. The Mastersizer 3000 software controls the system during the measurement process and analyzes the scattering data to calculate particle sizes in the form of D10, D50, and D90 volume-average particle size distributions. (For simplicity, these particle size distributions are referred to herein as "D10 particle size," "D50 particle size," and "D90 particle size.") It also provides both immediate feedback during method development and expert advice on the quality of results.

[0094] The D10, D50, and D90 values ​​of the particle size distribution are reported for monodisperse and polydisperse particle sizes. Figure 3 shows a chart of exemplary particle size distributions and percentiles (D10, D50, and D90), which are the sizes below which a particular volume of sample exists. For example, D50 indicates that 50 volume percent of the particles are below the reported value. Using the methods described herein, or other methods known in the art, various measurements of particle size distributions can be obtained, such as D1, D3, D5, D10, D50, D90, D95, D97, and D99.

[0095] Effect of temperature on particle size / shape Heating micronized natural waxes above their melting point (e.g., 80-90°C) significantly alters particle size and shape, and these samples do not exhibit the SPF and water-resistant properties exhibited by non-solubilized micronized wax samples. In light of this, it is even more unexpected that both water-resistant properties and SPF were improved by using non-solubilized micronized waxes at temperatures below the wax's melting point. While not wishing to be bound by or to any particular theory or principle, it is believed that the subject non-solubilized micronized natural waxes provide water-resistant properties by forming a hydrophobic film on the surface of the substrate. Furthermore, it is believed that the subject non-solubilized micronized natural waxes enhance the effectiveness of sunscreen formulations by diffracting incoming light and increasing the likelihood that the incident light will encounter sunscreen molecules.

[0096] In the following examples, the identified waxes were provided in powder form, as shown in Table 1, and then dispersed in caprylic / capric triglyceride (CCT), followed by heating to melt the wax. Different grades of carnauba wax were used in some of the examples presented herein. Carnauba wax is commercially available in three grades known to those skilled in the art: T1, T3, and T4, which vary in purity and color, with lower grades being darker. The dispersion contained 93 weight percent CCT, 5 weight percent wax, and 2 weight percent hyperdispersant, based on the total weight of the dispersion. "OPS" refers to the original D50 particle size (μm). "1 hr" refers to the D50 particle size (μm) after heating the dispersion to 90°C for 1 hour. "24 hr" refers to the D50 particle size (μm) after heating the dispersion to 90°C for 24 hours. Particle size values ​​were measured using the laser diffraction method described above. [Table 1]

[0097] Examples 11-15 were prepared using the ingredients and amounts listed below in Table 2. As used herein, "INCI" refers to the International System of Nomenclature for Cosmetic Ingredients, which names cosmetic ingredients. [Table 2]

[0098] The compositions listed in Table 2 were prepared as follows: The above compositions were prepared using typical emulsion preparation methods. Water and a chelating agent (disodium EDTA) were added to an appropriate sized container and mixed with a marine blade at 400 RPM until the chelating agent was completely dissolved. Next, a rheology modifier (Pemulen™ EZ-4U) was added and mixed at 400 RPM at 50°C until uniformly dispersed. Next, 1,3 propanediol was added. The oil phase ingredients (octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane, diisopropyl sebacate, polyglyceryl-3 laurate) were added to a separate, appropriately sized container and mixed at 70°C using a marine blade at 400 RPM until a one-phase, homogeneous blend was achieved. The oil phase was then cooled to 50°C. The SPF booster was then added to the appropriate phase and mixed until uniformly dispersed. Both the oil and water phases were then equilibrated at 50°C. The oil phase was then added to the water phase and mixed. The neutralizer was then added, which resulted in a significant increase in viscosity as the rheology modifier formed its structure in the emulsion. Therefore, an increase in mixing speed may be necessary. The preservative was then added, and the formulation was allowed to cool with mixing for an additional 30 minutes.

[0099] Example 11 was prepared at a processing temperature of 50°C. Example 12 was prepared at a processing temperature of 60°C. Example 13 was prepared at a processing temperature of 70°C. Example 14 was prepared at a processing temperature of 80°C. Example 15 was prepared at a processing temperature of 90°C. Examples 11-15 all used carnauba wax as the SPF booster. The melting point of carnauba wax is 82°C. Table 3 reports the Sun Protection Factor (SPF), the standard deviation (STD) of the SPF measurements, and the percent increase or decrease (%) for each composition compared to a control composition without an SPF booster. [Table 3]

[0100] These results demonstrate that the non-solubilized micronized wax described herein provides an SPF boost when in non-solubilized micronized form (Examples 11-14) compared to the solubilized wax (Example 15). Example 15 is believed to contain solubilized wax because the wax melted during preparation of the composition of Example 15. Also, the performance of Example 14 was not as good as that of Examples 11-13, and without wishing to be bound by theory, this is believed to be the result of Example 14 being processed at a temperature close to, but still below, the melting point of the SPF booster (carnauba wax, which has a melting point of 82°C), which may have begun to alter the wax particles. However, Example 14 is believed to contain non-solubilized micronized wax because the wax was not heated above its melting point.

[0101] Examples 16-37 were prepared using the ingredients and amounts listed in Table 4 below. [Table 4]

[0102] The compositions set forth in Table 4 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0103] All of Examples 16-37 were prepared at a processing temperature of 50°C. The SPF booster used in each example is listed in Table 5. Table 5 also lists the phase of the composition to which the SPF booster was added, the Sun Protection Factor (SPF), the standard deviation (STD) of the SPF measurement, the percent increase or decrease (%) of each composition compared to the control composition without the SPF booster (Example 16), and the critical wavelength (CWL) in nm of each composition. For Examples 35 and 37, the compositions could not be processed because the styrene / acrylate copolymer could only be processed in the aqueous phase. [Table 5]

[0104] In addition to showing the benefits of non-solubilized micronized waxes with respect to SPF boost, these examples also show that non-solubilized micronized waxes can be added to any phase of the present compositions, which has not been previously discovered.

[0105] Examples 38-56 were prepared using the ingredients and amounts listed in Table 6 below. [Table 6]

[0106] The compositions set forth in Table 6 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0107] All of Examples 38-56 were prepared at a processing temperature of 50°C. Table 7 lists the SPF booster used in each example, as well as the amount of SPF booster for each example. All SPF boosters listed in Table 7 were added "post-add" to the compositions. Table 7 also lists the standard deviation (STD) of the SPF measurements, the percent increase or decrease (%) for each composition compared to a control composition without an SPF booster (Example 38), and the critical wavelength (CWL) in nm for each composition. [Table 7]

[0108] Examples 57-76 were prepared using the ingredients and amounts listed in Table 8 below. [Table 8]

[0109] The compositions set forth in Table 8 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0110] All of Examples 57-76 were prepared at a processing temperature of 50° C. Table 9 lists the SPF booster used in each example, as well as the amount of SPF booster in each example ("A", wt %). Table 9 also lists the phase (P) of the composition to which the SPF booster was added (O = oil phase, W = water phase, PA = "post-add"), the Sun Protection Factor (SPF), and the after-light stable SPF (P-SP The SPF (SPF), water-resistant SPF (W-SPF), and standard deviation (STD) of each SPF measurement are listed. "SA" refers to styrene / acrylate copolymer. [Table 9]

[0111] Examples 77-86 were prepared using the ingredients and amounts listed in Table 10 below. [Table 10]

[0112] The compositions set forth in Table 10 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0113] All of Examples 77 to 86 were prepared at a processing temperature of 50°C. The PF boosters ("Booster 1" and "Booster 2") are listed in Table 11. All of the waxes in Examples 77-86 were "post-added" to this composition. Table 11 also lists the Sun Protection Factor (SPF), After-Light Stability SPF (P-SPF), After-Water Resistance SPF (W-SPF), and the standard deviation (STD) of each of the SPF measurements. [Table 11]

[0114] Examples 87-93 were prepared using the ingredients and amounts listed in Table 12 below. [Table 12]

[0115] The compositions set forth in Table 12 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0116] All of Examples 87-93 were prepared at a processing temperature of 50°C and included carnauba wax as an SPF booster. All of the waxes in Examples 87-93 were "post-added" to the compositions, except for Example 88, which was added to the oil phase. Table 13 shows the amount ("A", wt %) and grade ("G") of carnauba wax used, the Sun Protection Factor (SPF), post-light stable SPF (P-SPF), post-water resistant SPF (W-SPF), and the SPF measurement. The standard deviation (STD) of each of the values ​​is listed. [Table 13]

[0117] Examples 94 and 95 are provided to demonstrate that the non-solubilized micronized waxes of particular interest do not act as sunscreens / UV filters. Examples 94 and 95 were prepared using the ingredients and amounts listed in Table 14 below. [Table 14]

[0118] The compositions set forth in Table 14 were prepared according to the procedure described above for the compositions set forth in Table 2.

[0119] Examples 94-95 were prepared at a processing temperature of 50° C. The waxes in Examples 94-95 were "post-added" to the compositions. Table 15 lists the SPF booster used in each example, the Sun Protection Factor (SPF), and the standard deviation (STD) of each SPF measurement. [Table 15]

[0120] Examples 96-111 were prepared using the ingredients and amounts listed in Table 16 below. [Table 16]

[0121] The compositions listed in Table 16 were prepared as follows: In an appropriately sized container, mineral UV filters (zinc oxide and titanium dioxide) were homogenized with emollients (neopentyl glycol diethylhexanoate, cetyl octanoate, isopropyl isostearate) using an Ultra-Turrax® (IKA) homogenizer at 5000 RPM for 15 minutes at room temperature. The homogenization step is often used to disperse mineral UV filters and break them down into primary particle sizes. Next, stabilizers / hyperdispersants (polyhydroxystearic acid and neopentyl glycol diethylhexanoate) were added to the dispersed mineral UV filters, and the mixture was then heated to approximately 50°C while stirring at 200 RPM using a dispersing blade. In a separate appropriately sized container, the aqueous phase (water, rheology modifiers (polyurethane-62 and trideceth-6), sodium chloride) was heated to approximately 50°C and mixed at 200 RPM using a dispersing blade until the rheology modifier was uniformly dispersed. The SPF booster was then added to the appropriate phase and mixed until uniformly dispersed. Once both the oil and water phases reached the desired temperature and were homogeneous, the water phase was slowly added to the oil phase while mixing at 200 RPM using a dispersing blade. The resulting emulsion was then cooled to room temperature and preservatives (phenoxyethanol and ethylhexylglycerin) were added.

[0122] All of Examples 96-111 were prepared at a processing temperature of 50°C. The SPF booster used in each example is listed in Table 17. Table 17 also lists the compositions to which an SPF booster was added. The phase ("P") of the composition, the SPF of each composition, the standard deviation (STD) of the SPF measurements, the percent increase or decrease (%) of each composition compared to a control composition without an SPF booster (Example 96), and the critical wavelength (CWL) in nm of each composition are listed. For Examples 109 and 111, the compositions could not be processed because the styrene / acrylate copolymer could only be processed in the aqueous phase. [Table 17]

[0123] Examples 112-124 were prepared using the ingredients and amounts listed in Table 18 below. [Table 18]

[0124] The compositions set forth in Table 18 were prepared according to the procedures described above for the compositions set forth in Table 16.

[0125] All of Examples 112-124 were prepared at a processing temperature of 50° C., and the SPF booster was "post-added" to the compositions. The SPF booster used in each example, as well as the amount of SPF booster for each example ("A", wt %), is listed in Table 19. Table 19 also lists the SPF of each composition, the standard deviation (STD) of the SPF measurements, the percent increase or decrease (%) of each composition compared to a control composition without an SPF booster (Example 112), and the critical wavelength (CWL) in nm for each composition. [Table 19]

[0126] Examples 125-138 were prepared using the ingredients and amounts listed in Table 20 below. [Table 20]

[0127] The compositions set forth in Table 20 were prepared according to the procedure described above for the compositions set forth in Table 16.

[0128] All of Examples 125-138 were prepared at a processing temperature of 50°C. The SPF booster used in each example, as well as the amount of SPF booster in each example ("A", wt%), is listed in Table 21. Table 21 also lists the phase (P) of the composition to which the SPF booster was added (O = oil phase, W = water phase, PA = "post-add"), the sun protection factor (SPF), after-light-stable SPF (P-SPF), after-water-resistant SPF (W-SPF), and the standard deviation (STD) of each of the SPF measurements. "SA" refers to styrene / acrylate copolymer. [Table 21]

[0129] Examples 139-148 were prepared using the ingredients and amounts listed in Table 22 below. [Table 22]

[0130] The compositions set forth in Table 22 were prepared according to the procedure described above for the compositions set forth in Table 16.

[0131] All of Examples 139-148 were prepared at a processing temperature of 50°C. The SPF boosters ("Booster 1" and "Booster 2") used in each example are listed in Table 23. All of the waxes in Examples 139-148 were "post-added" to the compositions. Table 23 also lists the Sun Protection Factor (SPF), After-Light Stability SPF (P-SPF), After-Water Resistance SPF (W-SPF), and the standard deviation (STD) of each of the SPF measurements. [Table 23]

[0132] Examples 149-155 were prepared using the ingredients and amounts listed in Table 24 below. [Table 24]

[0133] The compositions set forth in Table 24 were prepared according to the procedures described above for the compositions set forth in Table 16.

[0134] All of Examples 149-155 were prepared at a processing temperature of 50°C and included carnauba wax as an SPF booster. All of the waxes in Examples 150-155 were "post-added" to the compositions, except for Example 150, which was added to the oil phase. Table 25 lists the amount ("A", wt %) and grade ("G") of carnauba wax used, the Sun Protection Factor (SPF), after-light stable SPF (P-SPF), after-water resistant SPF (W-SPF), and the standard deviation (STD) of each of the SPF measurements. [Table 25]

[0135] It is noted that T1 grade carnauba wax appears to be a more effective SPF booster in compositions containing inorganic UV filters, while T3 grade carnauba wax appears to be more effective in compositions containing organic UV filters.Without wishing to be limited by theory, it is believed that lighter colored SPF boosters may work better because inorganic UV filters mainly block UV rays through scattering and reflection.On the other hand, for organic UV filters, which mainly block UV rays through absorption, darker colored SPF boosters may work better.

[0136] Examples 156 and 157 were prepared according to the following instructions to explore the differences between the preparation methods: Example 156 contained the ingredients shown in Table 26, where percentages reflect weight percent based on the total weight of the entire composition. [Table 26]

[0137] In a clean crystal beaker, combine the ingredients of Phase A (acrylate / C 10-30 Alkyl acrylate crosspolymer) are mixed in with stirring, followed by acrylate / C with vigorous stirring. 10-30 The alkyl acrylate crosspolymer was added, followed by heating to 90°C. In a separate clean crystal beaker, the ingredients of Phase B were mixed with stirring while heated to 90°C. These two mixtures were then combined with vigorous stirring and homogenized at 10,000 rpm for 1 minute. The combined mixture was cooled to 30°C, followed by neutralization with Phase C, followed by the addition of Phase D.

[0138] Example 157 contained the same ingredients as Example 156, with the only difference being that the SPF booster was not included in Phase B. Rather, the SPF booster was retained until the end of the mixing process in Example 156, at which time the SPF booster was added under high shear for 2 minutes (using an IKA ULTRA-TURRAX® T25 disperser at 10,000 RPM). Because the SPF booster was retained until the end, it was not heated to 90°C as in Example 156, meaning that the SPF booster in Example 157 was unsolubilized. The SPF booster in Examples 156 and 157 was a mixture of carnauba wax and rice bran wax.

[0139] The in vitro SPF of Examples 156 and 157 was measured, with Example 156 having an SPF of about 23 and Example 157 having an SPF of about 35. This indicates that the non-solubilized SPF booster of Example 157 provides a clear SPF increase over the solubilized SPF booster of Example 156.

[0140] The particle size of each of the mixtures of Examples 156 and 157 was also measured and the results are shown in Table 27. [Table 27]

[0141] Because there are many components in each mixture that contribute to the measured particle size, it is difficult to determine with certainty what effect the solubilized SPF booster versus the non-solubilized SPF booster had on particle size. Nevertheless, it is clear that there is a difference in particle size between these Examples 156 and 157. Without wishing to be limited by theory, it is believed that the difference in particle size is primarily due to the SPF booster, and because the ingredients and preparation methods between the two Examples are otherwise the same, the difference in particle size may have contributed at least in part to the difference in the measured SPF between the two Examples.

[0142] Each of the documents referenced above is incorporated herein by reference, including any prior application to which priority is claimed, whether or not specifically listed above. The citation of any document is not an admission that such document qualifies as prior art in any jurisdiction or constitutes general knowledge of one of ordinary skill in the art. Except in the examples, or unless otherwise expressly indicated or required by context, all numerical quantities in this description specifying amounts of materials, reaction conditions, molecular weights, number of carbon atoms, and the like, are to be understood as being modified by the word "about." It should be understood that the upper and lower quantity, range, and ratio limits set forth herein are independently combinable, and that any amount within a disclosed range is intended to provide a minimum or maximum of a narrower range in alternative embodiments (provided, of course, that the minimum amount of a range must be lower than the maximum amount of that same range). Similarly, the ranges and amounts of each element of the subject matter disclosed herein may be used together with any ranges or amounts of other elements.

[0143] While certain representative embodiments and details have been shown for the purpose of illustrating the subject matter disclosed herein, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the scope of the subject matter. In this regard, the scope of the present invention is intended to be limited only by the claims that follow. In one embodiment, for example, the following items are provided: (Item 1) 1. A water-resistant and / or photoprotective composition comprising: a. an aqueous phase constituting 0% to 99.9% by weight of the composition, based on the total weight of the composition; b. an oil phase constituting 0% to 99.9% by weight of the composition, based on the total weight of the composition; c. an active sunscreen; d. a micronized non-solubilized wax comprising 0.1% to 10% by weight of the composition, based on the total weight of the composition; the wax has a D50 particle size of 1 to 100 μm and a melting point of at least 70° C., A composition, wherein the composition comprises at least 50% by weight of at least one of the aqueous phase or the oil phase. (Item 2) Item 2. The composition according to item 1, wherein the wax has a D50 particle size of 1 to 50 μm. (Item 3) 3. The composition according to claim 1, wherein the wax has a melting point of 70 to 100°C. (Item 4) 4. The composition according to any one of items 1 to 3, wherein the wax constitutes 1% to 5% of the composition, based on the total weight of the composition. (Item 5) 5. The composition according to any one of items 1 to 4, wherein the composition further comprises a stabilizing and / or emulsifying component. (Item 6) 6. The composition according to item 5, wherein the stabilizing and / or emulsifying component is present in the composition in an amount of 0.1% to 10% by weight, based on the total weight of the composition. (Item 7) 7. The composition according to any one of items 1 to 6, wherein the composition further comprises an artificial tanning agent. (Item 8) 8. The composition of any one of items 1 to 7, formulated as a cream, dispersion, emulsion, gel, ointment, lotion, foam, spray, or tonic. (Item 9) 1. A topically applicable cosmetic / dermatological sunscreen oil-in-water emulsion composition for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, the topically applicable cosmetic / dermatological sunscreen oil-in-water emulsion composition comprising: (a) an active sunscreen agent; and (b) a micronized non-solubilized natural wax, formulated in (c) a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier. (Item 10) A topically applicable cosmetic / dermatological formulation for ultraviolet photoprotection of the skin, scalp, lips, mucous membranes, and / or hair against the damaging effects of ultraviolet radiation, comprising: (a) an active sunscreen; and (b) a micronized non-solubilized natural wax, and (c) formulated in a topically applicable cosmetically / dermatologically acceptable vehicle, diluent, or carrier. (Item 11) 1. A water-resistant and / or photoprotective composition comprising: a. Constitutes 20% to 80% by weight of the composition based on the total weight of the composition An aqueous phase; b. an oil phase comprising 5% to 50% by weight of the composition, based on the total weight of the composition, the oil phase comprising an organic active sunscreen; c. a micronized non-solubilized natural wax comprising 1% to 5% by weight of the composition, based on the total weight of the composition; d. a stabilizing and / or emulsifying component comprising 1% to 10% by weight of the composition, based on the total weight of the composition; The composition, wherein the wax has a D50 particle size of 2 to 50 μm and a melting point of 70 to 100°C. (Item 12) 12. A method of reducing the effects of ultraviolet radiation on human skin, scalp, lips, mucous membranes, and / or hair by applying the composition according to any one of items 1 to 11 in an amount effective to at least partially reduce the effects of ultraviolet radiation. (Item 13) 12. Use of a composition according to any one of items 1 to 11 for ultraviolet photoprotection of human skin, scalp, lips, mucous membranes and / or hair against the damaging effects of ultraviolet radiation. (Item 14) 2. Use of a micronized non-solubilized wax in a sunscreen composition to improve the aesthetics and / or sun protection factor of said sunscreen composition.

Claims

[Claim 1] The invention described in the specification.

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