High-performance anhydrous sunscreen

Description

1 / 49 HIGH-PERFORMANCE ANHYDROUS SUNSCREEN FIELD OF APPLICATION

[001] The present invention relates to a cosmetic or pharmaceutical composition, preferably dermatological, for sun protection. FUNDAMENTALS OF THE INVENTION

[002] Ultraviolet (UV) radiation causes harmful effects to organisms, especially human skin. In addition to the acute effect of sunburn on the skin, UV radiation is also known to increase the risk of skin cancer. Furthermore, long-term exposure to UV-A and UV-B rays can cause phototoxic and photoallergenic reactions in the skin, and can accelerate its aging. The effects are direct or indirect from UV radiation, and in the latter case, are mainly mediated by free radicals. Therefore, there is interest in protecting against these aggressions, on the one hand by absorbing or reflecting UV rays and on the other hand by neutralizing free radicals.

[003] Human skin is sensitive to sunlight and artificial light in the wavelength range between approximately 290 and 400 nm (UV light). As previously mentioned, prolonged exposure to UV light causes serious skin problems, ranging from erythema, sunburn, redness, and blisters to carcinomas. With the increasing incidence of skin cancer cases, such as squamous cell and basal cell carcinomas, being reported worldwide, the use of photoprotective agents has increased over the years. Photoprotective agents are commonly used therapeutically or prophylactically.

[004] Photoprotection is considered an essential public health measure in the prevention of skin cancer, the most frequent cancer in the human body. Within photoprotection measures, the regular use of sunscreens is recommended by all entities involved in the subject, such as regulatory agencies, dermatology societies, and ministries and Petition 870250012175, dated 02 / 14 / 2025, page 9 / 65 2 / 49 health departments.

[005] Most available sunscreens are oil-in-water or water-in-oil emulsions. This form of presentation requires a higher concentration of UVA and UVB filters to obtain products with a high sun protection factor (SPF), as currently recommended by dermatologists. In addition, the complexity of the formulation requires the combination of many ingredients and a sensory delivery that often does not encourage the user to apply the product correctly, either in the amount applied or in the need for reapplication.

[006] Sunscreens are products with extensive formulas containing a large number of ingredients and higher concentrations of components that can potentially produce adverse effects on the user and risks to the environment, in addition to an often frustrating sensory experience.

[007] Previous attempts to develop anhydrous sunscreens (i.e., without water, and therefore in a single-phase (oil) system) were disappointing from a sensory point of view, and often led consumers to use them in smaller quantities, thus posing health risks. Some formulations still required the use of silicones and various solubilizers, often aggressive for the dispersion of the ingredients. As a result, silicones are being banned in many countries because they are non-biodegradable ingredients.

[008] There has been significant development of photoprotection solutions that offer minimalist formulas, with fewer ingredients and lower concentrations of UV filters, while providing high protection (Sun Protection Factor - SPF and UVA Protection) and sensory experiences that contribute to the correct use of sunscreen, in addition to being environmentally sustainable.

[009] One of the major concerns of policymakers in Petition 870250012175, dated 02 / 14 / 2025, page 10 / 65 3 / 49 Regarding sun products, research focuses on methods to increase SPF without increasing the number of sunscreen ingredients. This makes the product cheaper, with less potential for adverse effects, and with an excellent sensory experience.

[0010] Substances capable of increasing SPF are called enhancers, which are often applied at the maximum concentration allowed by legislation, and although they are safe, they pose an allergenic potential to consumers who are more sensitive or have sensitized skin. The ingredients in the formulation, such as sunscreens, emollients, and others, must be carefully selected, as they may increase the SPF of a particular formulation but not others, or even bring a greater potential for adverse effects.

[0011] Patent document US2023293403 discloses a cosmetic or pharmaceutical composition, preferably dermatological, comprising or consisting of a liquid lipophilic component and an effective amount of 1,2-heptanediol and / or 2,3-heptanediol or a specific alkanediol or a mixture of two or more different specific alkanediols and the use of said compositions as a cosmetic, for personal care, as a pharmaceutical product or for animal care. Additionally, document US2023293403 describes the use of said composition to improve the sensory properties, i.e., the feel on the skin, of a cosmetic or pharmaceutical composition by topical application.

[0012] However, among the pharmaceutical forms of the formulation claimed in patent document US2023293403 there is an ointment, that is, a monophasic formulation that is usually composed of petrolatum (petroleum derivatives), and therefore has a very greasy feel and the potential to cause acne lesions due to follicular occlusion. Thus, the sunscreen in the US patent document requires silicone as an antifoaming agent in its composition, and Petition 870250012175, dated 02 / 14 / 2025, page 11 / 65 4 / 49 agents with affinity for water such as emulsifiers, thickeners, aqueous phase polymers, low viscosity thickeners, hydrophilic agents and aqueous extracts.

[0013] In contrast, the formulation of the present invention is a completely anhydrous solid or semi-solid pharmaceutical form, a monophasic formulation balm, but which does not comprise petrolatum as a vehicle, but rather a surprising combination of emollients, emulsifiers, suspending agents and sensory modifiers together with UV filters. Furthermore, the photoprotector of the present invention does not contain C12-C15 alkyl benzoate, as it imparts unwanted shine and oiliness to both the photoprotector and the skin.

[0014] Furthermore, the present formulation does not employ homosalate and octocrylene, which are filters considered controversial because they can be toxic to aquatic environments or even endocrine disruptors. Liposomes and pure vegetable oils are also not part of the formulation of the present invention, since they can impart an oily feel to the formulation. In addition, the photoprotector of the present invention does not include silicone, which is a synthetic polymer derived from siloxane, but rather silica, which is a natural substance generated from silicon and used in various industrial and consumer applications, including glassmaking and as a filler in paints, plastics, and rubber.

[0015] Patent document WO23009315 teaches a sunscreen composition comprising (i) about 0.01% by weight to about 20% by weight of avobenzone, (ii) about 0.01% by weight to about 20% by weight of benzyl o-toluate; and (iii) about 0.01% to about 95% by weight of at least one additive; and a method for solubilizing and photostabilizing avobenzone in a sunscreen composition using an effective amount of benzyl o-toluate.

[0016] However, the present invention differs from Petition 870250012175, dated 02 / 14 / 2025, page 12 / 65 5 / 49 patent document WO23009315 because its formulation does not contain the following components: benzyl o-toluate, homosalate, octocrylene, benzophenone 3, zinc oxide, butyloctyl salicylate, cetyl alcohol, isoctyl alcohol, isodecyl neopentanoate, isostearyl neopentanoate, isoctyl stearate, diisopropyl adipate, lauryl lactate, octyl palmitate, C12C15 alkyl lactate, dicaprylyl carbonate, isodecyl salicylate, glycerin, glyceryl acrylate / acrylic acid copolymer, polymethylvinyl ether / maleic anhydride copolymer (PVM / MA), octyl palmitate, diisopropyl adipate and alkyl benzoate. C12-C15 combined with filters.

[0017] However, in contrast, the formulation of the present invention does not combine avobenzone with benzyl o-toluate for its stabilization; instead, the stabilization of avobenzone is done with bis-ethylhexyloxyphenol methoxyphenyl triazine, which, in addition to promoting the stabilization of avobenzone, is also a UVA and UVB filter capable of increasing the SPF of the sunscreen. As preservatives, the present invention comprises 1,2-hexanediol and caprylyl glycol, and as rheology modifiers, hectorite, hydrogenated vegetable oil, and silica are used, the latter of which surprisingly modified the rheology of the present invention.

[0018] Unlike the composition of WO23009315, the composition of the present invention comprises as a suspending agent only stearalkonium hectorite, caprylic / capric triglyceride and propylene carbonate. Compounds such as benzyl o-toluate, homosalate, octocrylene, benzophenone 3, zinc oxide, butyl salicylate, butyl octyl salicylate, cetyl alcohol, isocetyl alcohol, isodecyl neopentanoate, isostearyl neopentanoate, isocetyl stearate, diisopropyl adipate, lauryl lactate, octyl palmitate, C12-C15 alkyl lactate, isodecyl salicylate, glycerin, glycerin, copolymer of Petition 870250012175, dated 02 / 14 / 2025, page 13 / 65 6 / 49 glyceryl acrylate, acrylic acid, PVM / MA copolymer, octyl palmitate and diisopropyl adipate. The present invention combined the use of hydrogenated vegetable oil, a modifying and conditioning agent that surprisingly contributed to the stability of the formulation.

[0019] Patent application WO2014114888 refers to a cosmetic composition that provides protection against environmental aggressions and in particular against UV rays, namely through an anti-radical efficacy. The formulation of application WO2014114888 is a cosmetic composition free of inorganic UV protection agents and organic UV filters listed by European regulation 1223 / 2009, comprising, in combination, karanja oil and pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate (INCI). It advantageously possesses an in vitro SPF value of at least 15, a UVB / UVA ratio of less than 2 and photostability greater than 70%.

[0020] On the other hand, the present invention does not include karanja oil in combination with UV filters, nor mineral filters, whether in their natural versions or in nanoparticles, since mineral, non-nanoparticle and nanoparticle filters have low cosmetic acceptance, with a whitish appearance that inhibits proper use by consumers.

[0021] Patent document WO23049822 discloses personal care compositions, including Camellia sinensis (green tea) extract present in an effective amount to provide enhanced antioxidant power, and which may be in crystalline dosage form. The Camellia sinensis (green tea) extract may be initially dispersed in an aqueous solvent to provide an aqueous dosage form, and may also be initially dispersed in a non-aqueous anhydrous solvent to provide a non-aqueous dosage form. The personal care composition may also include a sunscreen filter, Petition 870250012175, dated 02 / 14 / 2025, page 14 / 65 7 / 49 a vitamin or a derivative thereof.

[0022] Conversely, the present invention does not contain Camellia sinensis, which is a phytoextract with antioxidant properties, as said extract does not provide any benefit to the product's stability nor does it promote photoprotective efficacy, thus becoming an ingredient without additional benefit.

[0023] Furthermore, the present invention differs from patent application WO23049822 in that it does not include alcohol as a vehicle in the photoprotector composition, since alcohol can be an ingredient capable of causing burning in skin already damaged by sun exposure. In addition, alcohols have a low water concentration, which would eliminate the anhydrous effect of the invention.

[0024] US patent 4894222 refers generically to a skin-protective composition that exhibits enhanced water repellency and, more particularly, to a composition containing aliphatic waxes and anhydrous hydrophobic starch in a pharmacologically acceptable, water-free vehicle which, when mixed with sunscreen and applied topically to exposed human skin, is effective not only in protecting against ultraviolet radiation but also in waterproofing skin surfaces without stickiness, thereby increasing user adherence and substantially reducing skin damage that would otherwise result from exposure to such solar radiation.

[0025] The present invention does not include aliphatic C18C36 wax as a component of the sunscreen formulation, as these promote a greasy feel. Also, the invention does not include anhydrous starch for waterproofing and vegetable oil, since it was tested in previous versions of the present invention and produced a more fluid appearance of the product, therefore being rejected, as the objective of the present invention is a balm with a single-phase formulation. Petition 870250012175, dated 02 / 14 / 2025, p. 15 / 65 8 / 49 is completely anhydrous, which does not use petrolatum as a vehicle, but rather a surprising combination of emollients, emulsifiers, suspending agents and sensory modifiers along with UV filters.

[0026] US patent 11510855 discloses improved sunscreen formulations that simultaneously address and overcome the various problems and at least one of the limitations or disadvantages associated with prior art sunscreen formulations. In particular, the US patent aims to provide a sunscreen formulation that is invisible upon application to the skin, does not stain, is not oily, and can be used to prevent skin disorders resulting from UV light exposure.

[0027] On the other hand, the present invention is a dry-feel photoprotective balm, with a single-phase, totally anhydrous formulation, which does not use petrolatum as a vehicle but rather a surprising combination of emollients, emulsifiers, suspending agents and sensory modifiers together with UV filters. Furthermore, the present invention comprises sensory-absorbing powders that provide a dry feel, and does not contain zinc oxide or mixtures thereof, thus avoiding a whitish feel that negatively interferes with consumer acceptance.

[0028] Furthermore, US patent 11510855 is a monophasic formulation ointment, usually composed of petrolatum (petroleum derivatives), which has a very greasy feel and a potential for causing acne lesions due to follicular occlusion. The present invention differs from the US patent by not including alcohol as a vehicle in the sunscreen composition, as alcohol can be an ingredient capable of causing burning in skin already damaged by sun exposure. In addition, alcohols have a low water concentration, which would eliminate the effect. Petition 870250012175, dated 02 / 14 / 2025, page 16 / 65 9 / 49 anhydrous of the invention.

[0029] Patent FR2986423 discloses topical sunscreen formulations comprising a semi-fluorinated alkane and a metal oxide selected from titanium dioxide, zinc oxide, or mixtures thereof. Furthermore, the objective of the French patent is to provide a sunscreen formulation that is invisible upon application to the skin, does not stain or leave an oily residue, and can be used to prevent skin disorders resulting from exposure to UV light.

[0030] In contrast, the present invention does not use inorganic filters to stabilize the formula. And differing from patent FR2986423, the present invention is an anhydrous formulation, which has a superior sensory perception effect clearly identified by the consumer, offering a dry and silky touch, reducing skin shine with a mattifying effect. This effect is obtained by the absence of mineral filters used in the French patent, in addition to other sensory modifiers, such as esters and silicas present in the invention.

[0031] Patent FR2982148 discloses topical sunscreen formulations comprising a semi-fluorinated alkane and a metal oxide selected from titanium dioxide, zinc oxide, or mixtures thereof. Furthermore, the sunscreen formulations of the French patent simultaneously address and overcome several problems and at least one of the limitations or disadvantages associated with prior art sunscreen formulations. In particular, the objective of the French patent is to provide a sunscreen formulation that is invisible upon application to the skin, does not stain or leave an oily residue, and can be used to prevent skin disorders resulting from exposure to UV light.

[0032] The present invention, however, does not use inorganic (or mineral) filters in its composition to stabilize the formula, as these are ingredients that promote an appearance Petition 870250012175, dated 02 / 14 / 2025, page 17 / 65 10 / 49 whitish, rejected by consumers. Furthermore, the present invention has the superior effect of clearly identified consumer sensory perception, offering a dry and silky touch, reducing skin shine with a mattifying effect. This effect is obtained by the absence of mineral filters used in patent FR2982148, in addition to other sensory modifiers, such as esters and silicas present in the invention.

[0033] As noted, the state of the art would benefit from a solution that presents an anhydrous sunscreen in the form of a dry balm, which efficiently comprises photostable and demonstrably safe UV filters, a combination of different emollient agents, sensory modifiers and oil absorbers, capable of being environmentally sustainable in an anhydrous (waterless) system, without the use of microplastics or non-biodegradable agents. Furthermore, a sunscreen that delivers maximum efficiency with a surprisingly good sensory feel, while remaining dry (without an oily touch) and rapidly absorbed.

[0034] Furthermore, the sunscreen of the present invention allows for the maximum efficiency of UV filters, i.e., lower concentrations of filters delivering high SPF and UVA protection, where there is an appropriate combination of UVA and UVB filters. This results in a direct benefit for the user (less exposure to filters and other elements, i.e., less skin irritation) and for the environment (lower quantities of filters and other ingredients present in water treatment systems, coral reefs, and rivers and seas). BRIEF DESCRIPTION OF THE INVENTION

[0035] The present invention relates to a photoprotective formulation that efficiently combines photostable and demonstrably safe UV filters with a novel technology combining different emollient agents.

[0036] In addition to different modifiers of Petition 870250012175, dated 02 / 14 / 2025, page 18 / 65 11 / 49 sensory / oil-absorbing properties, capable of providing a dry, velvety feel and rapid absorption in an anhydrous (waterless) and alcohol-free system.

[0037] The following are definitions for cosmetics terms used in this report to clarify their understanding:

[0038] Balsam: or balm is a term that can refer to various cosmetic products, for example photoprotective balm, a semi-solid to solid cosmetic preparation at room temperature, in most cosmetics anhydrous, which melts at room temperature and spreads when it comes into contact with the heat of the skin.

[0039] Sensory modifier: These are ingredients used to improve the sensory characteristics of a cosmetic formulation. They are the compounds responsible for factors such as dry touch, freshness, increased spreadability, matte effect, and others.

[0040] Emollient or skin conditioner: these are raw materials that provide softness and spreadability of the formulation on the skin, softening and smoothing it.

[0041] Solvent: is a substance that can dissolve other substances.

[0042] Oil absorbers: can also be called sensory modifiers and aim to control skin oiliness.

[0043] UV absorber: is a raw material that slows down the photodegradation of the product.

[0044] UV light stabilizer: These are raw materials that do not alter the appearance characteristics such as color and odor in the product, stabilizing the formula when it is susceptible to changes when exposed to UV light.

[0045] UV filter: raw materials that absorb UV light.

[0046] Gel former / viscosity: these are raw materials Petition 870250012175, dated 02 / 14 / 2025, page 19 / 65 12 / 49 thickeners, which change the viscosity, stability, sensory characteristics and rheology of the product.

[0047] Viscosity modifier: These are raw materials that maintain the thickening of the product within the expected viscosity range.

[0048] Opacifier: raw materials that mask the color and appearance of the product.

[0049] Absorbent: raw materials that absorb oil leaving a mattifying effect.

[0050] Antioxidant: These are raw materials that protect the formula from oxidation and degradation.

[0051] Thickening agent: raw materials that alter the viscosity of the product. BRIEF DESCRIPTION OF THE FIGURES

[0052] The subject matter of this invention will become fully clear in its technical aspects from the detailed description that will be made based on the figures below: Figure 1 illustrates the final formulation of the photoprotector after fabrication in inert glass; Figure 2 illustrates the final formulation of the photoprotector after fabrication on a watch glass without spreading; Figure 3 illustrates the final formulation of the photoprotector, completely homogeneous after manufacturing on a watch glass, spreading across the entire surface of the glass, showing its transparency, homogeneity, and absence of lumps and powder. DETAILED DESCRIPTION OF THE INVENTION

[0053] The present invention relates to a cosmetic or pharmaceutical composition, preferably dermatological, for sun protection using an anhydrous (water-free), alcohol-free, silicone-free system, promoting a dry, velvety feel and rapid absorption.

[0054] The decision was made to start Research and Development Petition 870250012175, dated 02 / 14 / 2025, page 20 / 65 13 / 49 of a new photoprotective formulation aiming at the concept of an anhydrous system, that is, without water, and minimalist. Furthermore, the development of a solid or semi-solid photoprotector with UV powder filters and a pleasant, velvety feel, free of silicones, was sought.

[0055] The major challenge in development is obtaining an anhydrous system with a pleasant, dry feel, free of residue or oiliness, that would invite the user to a positive experience and thus encourage its use in the quantity and frequency recommended by health authorities.

[0056] An anhydrous system, therefore without water, evokes a negative sensory experience, with an oily / greasy appearance, reminiscent of an ointment or salve to the touch. This experience would be disastrous for a sunscreen.

[0057] Research was conducted in search of solutions for anhydrous systems with improved sensory properties. However, the inventors did not identify any products on the market that possessed these characteristics, since historically only products containing high concentrations of silicones were launched and, moreover, subsequently discontinued.

[0058] Silicones are ingredients being phased out in many countries due to their non-biodegradability and strong environmental impact. As one of the objectives of the present invention is also to offer an environmentally sustainable product, the use of silicones in the formulation of the proposed sunscreen would not be acceptable.

[0059] Thus, the aim was to develop a formulation comprising a combination of powdered UVA and UVB filters, i.e., an innovative emollient system with sensory modifiers. However, to solubilize the powdered UV filters, the need to use a dry ester, dicaprylyl carbonate, with a pleasant sensory profile, in high concentration to solubilize the filters was identified, thus requiring a low quantity of filters. Petition 870250012175, dated 02 / 14 / 2025, page 21 / 65 14 / 49 which ultimately provide a high SPF (50+), achieving the goal of using the minimum amount of UV filters possible. SUN FILTERS

[0060] UVB and UVA filters are selected from the group consisting of diethylaminohydroxybenzoyl hexyl benzoate, diethylhexyl butamido triazone, butyl methoxydibenzoylmethane (avobenzone), bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl triazone, cinnamates, triazines, inorganic filters (titanium dioxide and zinc oxide, salicylates and octocrylenes. EMOLLIENTS

[0061] Emollients or skin conditioners affect spreadability, solubility, improved formation of the protective film on the skin, skin penetration capacity (mainly in the stratum corneum), and can alter the absorption spectrum of certain sunscreens. The effectiveness of the sunscreen is related to the thickness of the film and its spreadability. Emollients exhibit different behaviors for different types of sunscreens and should be selected according to the desired result.

[0062] The emollients were selected from the group consisting of dicaprylyl carbonate CETIOL CC, CETIOL AB - C12C15, cetearyl isononanoate, coconut caprylate.

[0063] Dicaprylyl carbonate is a fast-spreading emollient with a velvety feel on dry skin for all cosmetic applications, and is particularly suitable for sun protection formulations due to its solubilizing capabilities, as well as being suitable for dispersing pigments and sunscreens. Furthermore, it positively supports the cleansing efficacy of emulsion-based facial cleansers. It is a clear, colorless, almost odorless oil of low polarity and low molecular weight.

[0064] Furthermore, dicaprylyl carbonate is a versatile cosmetic ingredient commonly used in skin products and Petition 870250012175, dated 02 / 14 / 2025, page 22 / 65 15 / 49 Personal Care. It is an ester derived from caprylic acid and carbonic acid. This compound is valued for its light and silky texture, which makes it an excellent emollient and spreader in various formulations.

[0065] Dicaprylyl carbonate is called a carbonate ester or carbonic acid ester. Esters are known to be compounds of an alcohol and an acid. In the case of dicaprylyl carbonate, the starting ingredients are caprylic alcohol and carbonic acid. This raw material is a clear, odorless, colorless oil with 94% natural / vegetable origin.

[0066] Dicaprylyl carbonate is a fast-spreading emollient for all cosmetic applications where a distinctive sensory feel is desired, as it reduces the greasy feel of vegetable oils and butters, promoting a dry and velvety touch in emulsions. It is particularly suitable for formulations for dry skin and sun protection due to its excellent solubilizing capabilities for crystalline UV filters.

[0067] Due to all these characteristics, dicaprylyl carbonate is an emollient indicated as an alternative to volatile silicones such as cyclomethicone (silicones).

[0068] Like other esters, dicaprylyl carbonate is lightweight and spreads quickly with a dry, velvety feel. Cetiol AB - C12-15 alkyl benzoate is a mixture of benzoic acid esters consisting of benzoic acid and alcohols with chain lengths of 12 to 15 carbons. This product completely dissolves UV filters, improves film solubility and integrity, enhances the dispersion of inorganic and organic filters, and aids in film formation by thickening the sunscreen film to improve distribution and protection.

[0069] Cetearyl isononanoate is a medium-spreading emollient for properly composing the cascade of Petition 870250012175, dated 02 / 14 / 2025, page 23 / 65 16 / 49 emollients.

[0070] Coconut caprylate is a fast-spreading emollient for personal care applications, especially suitable as an alternative to volatile silicones such as cyclomethicone, and is 100% obtained from renewable materials.

[0071] Caprylic / capric triglyceride is a glycerol ester obtained through the reaction of caprylic / capric acid and glycerol.

[0072] MCT - Medium Chain Triglycerides (MCT Cs / Ciü) is a high-purity, vegetable-derived, biodegradable, low-viscosity triglyceride that is miscible in most oils and esters. It is also resistant to oxidation and temperature variations.

[0073] The combination of Undecane and Tridecane is the ultimate sensory solution for unique textures in no-rinse skincare applications. This 100% renewable emollient is super volatile, has ultra-high spreadability, and is ECOCERT certified. Absorbent Agents - Sensory Modifiers

[0074] Several agents were tested to select sensory modifiers, not only to evaluate stability, appearance, color, but also performance and Sun Protection Factor (SPF).

[0075] Examples of sensory modifiers / absorbers (INCI) Tested in 11 / 2021 and documented: calcium and sodium borosilicate, aluminum starch octenylsuccinate, polymethylsilsesquioxane 1, perlite 1 with a particle size of 3 µm, perlite 2 with a particle size of 25 µm, perlite 3 with a particle size of 400 µm, HDI / Trimethylol hexyl / trimethylol polymethyl methacrylate (PMMA) crosspolymer sheet, polyamide-5, polymethylsilsesquioxane 2, Oryza sativa bark powder or silica, polymethylsilsesquioxane + silica. Petition 870250012175, dated 02 / 14 / 2025, page 24 / 65 17 / 49 Silica Particle Size: Silica class 1 (INCI) 10 to 14 µm; Silica class 2 (INCI) 7 µm; Silica class 3 (INCI) 6 µm; Silica class 4 (INCI) 6 to 15 µm

[0076] The choice of ideal sensory modifiers was an important item for the success of the present invention, as the sensory modifier is able to not interfere with the SPF value nor impact the final aspect of the product, such as color and spreadability. Thickening agents

[0077] The thickening agents are selected from the group consisting of stearalkonium hectorite, hydrogenated vegetable oil, xanthan gum, tara gum, carbomer, ethylcellulose, carboxymethylcellulose, silica dimethyl silylate, polyacrylate copolymer.

[0078] Among the various thickening agents tested, hectorite produced the best results as a thickening, suspending, and viscosity-enhancing agent for thickening the formula and suspending the non-soluble silica powder.

[0079] Formulation tests showed that adding dicaprylyl carbonate along with silica in a system with a low number of UV filters and low concentration in a semi-solid formula results in an increase in the SPF system, and a product with better performance in efficacy, appearance and sensory feel when compared to formulations on the market. ANTIOXIDANT AGENTS

[0080] The antioxidant agents are selected from the group consisting of tocopherol acetate and pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, hydroxytyrosol (HT), butylated hydroxyanisole (BHA), ascorbic acid and palmityl ascorbate.

[0081] The following examples show the results of Petition 870250012175, dated 02 / 14 / 2025, page 25 / 65 18 / 49 tests of viscosity agents / modifiers (Example 1), test of sensory modifiers X emollient (Example 2), melting and dispersion of solids (Example 3), formulation of an anhydrous photoprotector with a dry, velvety feel and rapid absorption (Example 4).

[0082] Tests with viscosity agents / modifiers were carried out using different viscosity agents. The aim of this test was to verify which viscosity modifier would be most suitable for the designed formulation (a balm with a dry feel, single-phase formulation), in relation to the physicochemical behavior of the combination of ingredients, the stability of the formulation (no changes in color, appearance and odor, and no phase separation), the dispersion of each component, and the final homogeneity of the product so that recrystallization and phase separation did not occur, and finally, that it provided perfect spreadability on the skin. Example 1 - Test of agents / viscosity modifier experimental batch Table 1 - Experimental batch 1 with viscosity agent: synthetic carnauba wax Petition 870250012175, dated 02 / 14 / 2025, page 26 / 65 19 / 49 CAS No. INCI Name Anhydrous System Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Viscosity Modifier NA SYNTHETIC CARNAUBA 0.001 10.00 FAILED Viscosity Modifier Solvent 108-32-7 2 Propylene Carbonate 0.001 2.000 NA UV Absorber - Light Stabilizer - UV Filter 302776-68-7 3 Diethylaminohydroxybenzoyl hexyl benzoate 1.000 9.000 NA Skin Conditioner - Emollient 68334-28-1 4 Hydrogenated Vegetable Oil 0.500 5.000 NA Antioxidant 6683-19-8 5 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate 0.010 1.000 NA UV absorber - Light stabilizer - UV filter 18739 3-00-6 6 Bis-ethylhexyloxyphenol methoxyphenyl triazine 0.500 8.000 NA UV absorber - Light stabilizer - UV filter 6197-30-4 7 Octocrylene 1.000 9.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 27 / 65 20 / 49 CAS No. INCI Name Anhydrous System Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) UV Absorber - UV Filter 118-56-9 8 Homosalate 1.000 13.500 NA Opacifier Absorbent - Viscosity Modifier Sensory Modifier 763186-9 / 112945-52-5 / 60676-86-0 9 Silica 1.000 50.000 NA Skin Conditioner 533-75-5 10 Tropolone 0.100 1.000 NA Skin Conditioner 6920-22-5 11 1,2-Hexanediol 0.100 1.000 NA Skin Conditioner 1117- 86-8 12 Caprylyl Glycol 0.100 1.000 NA Antioxidants - Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopheryl Acetate 0.100 2.000 NA Skin Conditioner - Emollient _ 14 Coco Caprylate 0.500 10.000 NA Skin Conditioner - Emollient 11193 7-03-2 16 Cetearyl Isononanoate 0.100 6.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 28 / 65 21 / 49 CAS No. INCI Name Anhydrous System Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 17 Caprylic / Capric Triglyceride 1.000 3.500 NA Skin Conditioner - Emollient 68411-27-8 18 C12-C15 Alkyl Benzoate 1.000 40.000 NA Skin Conditioner - Emollient 1680-31-5 19 Dicaprylyl Carbonate 1.000 40.000 NA UV Absorber - Light Stabilizer - UV Filter 70356-09-1 20 Avobenzone INCI: Butyl methoxydibenzoyl Methane 0.1 4,500 NA UV Absorber Light Stabilizer - UV Filter 88122 -99-0 21 Ethylhexyl triazone 0.1 4,500 NA qsp _ _ 100% 100% _

[0083] Test 1 failed because the synthetic carnauba wax gave experimental batch 1 a rigid, non-slip appearance, making industrial production impossible. Table 2 - Experimental batch 2 with viscosity agent: wax Petition 870250012175, dated 02 / 14 / 2025, page 29 / 65 22 / 49 of candelilla CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) FILM former 8006-44-8 CANDELILLA WAX 0.001 10.00 FAILED Viscosity modifier Solvent 108-32-7 2 Propylene Carbonate 0.001 2.000 NA UV absorber - Light stabilizer - UV filter 302776-68-7 3 Diethylamino hydroxybenzoyl hexyl benzoate 1.000 9.000 NA Skin conditioner - emollient 68334-28-1 4 Hydrogenated vegetable oil 0.500 5.000 NA Antioxidant 6683-19-8 5 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate 0.010 1.000 NA UV absorber - Light stabilizer - UV filter 187393-00-6 6 Bis-ethylhexyloxyphenol methoxyphenyl triazine 0.500 8.000 NA UV absorber - Light stabilizer 6197-30-4 7 Octocrylene 1.000 9.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 30 / 65 23 / 49 CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Light - UV Filter UV Absorber - UV Filter 118- 56-9 8 Homosalate 1.000 13.500 NA Opacifier Absorber - Viscosity Modifier Sensory Modifier 763186-9 / 112945 -52-5 / 6067686-0 9 Silica 1.000 50.000 NA Skin Conditioner 533- 75-5 10 Tropolone 0.100 1.000 NA Skin Conditioner 6920- 22-5 11 1,2-Hexanediol 0.100 1.000 NA Skin Conditioner 1117-86-8 12 Caprylyl Glycol 0.100 1.000 NA Antioxidants - Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopheryl Acetate 0.100 2.000 NA Skin Conditioner - Emollient _ 14 Coco Caprylate 0.500 10.000 NA Skin Conditioner - Emollient 111937-03-2 16 Cetearyl Isononanoate 0.100 6.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 31 / 65 24 / 49 CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Solvent - Skin Conditioner 7339861-5 / 6538109-1 17 Caprylic / Capric Triglyceride 1.000 3.500 NA Skin Conditioner - Emollient 68411-27-8 18 C12-C15 Alkyl Benzoate 1.000 40.000 NA Skin Conditioner - Emollient 1680-31-5 19 Dicaprylyl Carbonate 1.000 40.000 NA UV Absorber - Light Stabilizer - UV Filter 70356-09-1 20 Avobenzone INCI: Butyl methoxydibenzoyl methane 0.1 4,500 NA UV absorber Light stabilizer - UV filter 88122 -99-0 21 Ethylhexyl triazone 0.1 4,500 NA qsp _ _ 100% 100% _

[0084] Test 2 failed with candelilla wax, as this wax gave experimental batch 2 a rigid, non-slip appearance, with phase separation after 24 hours at room temperature, at rest, and made industrial production impossible. Petition 870250012175, dated 02 / 14 / 2025, page 32 / 65 25 / 49 Table 3 - Experimental batch 3 with viscosity agent: ozokerite wax CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) FILM Former, VISCOSITY MODIFIER 64742-33-2 OZOKERITE 0.001 10.00 REJECTED Viscosity modifier - Solvent 108-32-7 2 Propylene Carbonate 0.001 2.000 NA UV absorber Light stabilizer UV filter 302776-68-7 3 Diethylamino hydroxybenzoyl hexyl benzoate 1.000 9.000 NA Skin conditioner - emollient 68334-28-1 4 Hydrogenated vegetable oil 0.500 5.000 NA Antioxidant 6683-19-8 5 Pentaerythrityl Tetra-di-tbutyl Hydroxyhydrocin amate 0.010 1,000 NA Petition 870250012175, dated 02 / 14 / 2025, page 33 / 65 26 / 49 CAS No. INCI Name Anhydrous System Melting Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) UV Absorber Light Stabilizer UV Filter 187393-00-6 6 Bis-ethylhexyloxyphenol methoxyphenyl triazine 0.500 8.000 NA UV Absorber - Light Stabilizer UV Filter 6197-30-4 7 Octocrylene 1.000 9.000 NA UV Absorber UV Filter 118-56-9 8 Homosalate 1.000 13.500 NA Opacifier Absorbent Viscosity Modifier - Sensory Modifier 7631-86-9 / 112945-52-5 / 60676-860 9 Silica 1,000 50,000 NA Skin Conditioner 533-75-5 10 Tropolone 0.100 1,000 NA Skin Conditioner 6920-22-5 11 1,2-Hexanediol 0.100 1,000 NA Petition 870250012175, dated 02 / 14 / 2025, page 34 / 65 27 / 49 CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Skin Conditioner 1117-86-8 12 Caprylyl Glycol 0.100 1.000 NA Antioxidants Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopheryl Acetate 0.100 2.000 NA Skin Conditioner - emollient 14 Coco Caprylate 0.500 10.000 NA Skin Conditioner - emollient 111937-03-2 16 Cetearyl Isononanoate 0.100 6.000 NA Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 17 Caprylic / Capric Triglyceride 1,000 3,500 NA Skin Conditioner - Emollient 68411-27-8 18 C12-C15 Alkyl Benzoate 1,000 40,000 NA Skin Conditioner - Emollient 1680-31-5 19 Dicaprylyl Carbonate 1,000 40,000 NA UV Absorber / Stabilizer 70356-09-1 20 Avobenzone INCI: Butyl 0.1 4,500 NA Petition 870250012175, dated 02 / 14 / 2025, page 35 / 65 28 / 49 CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Light Absorber UV Filter Methoxydibenzoyl methane UV Absorber Light Stabilizer UV Filter 88122-99-0 21 Ethylhexyl triazone 0.1 4,500 NA qsp _ _ 100% 100% _

[0085] Test 3 failed with ozokerite wax, as this wax gave experimental batch 3 a rigid, non-slip, sandy appearance, with phase separation after 6 days at a temperature of 30°C in an oven, and at rest, which made industrial production impossible. Table 4 - Experimental batch 4 with viscosity modifier: stearalkonium hectorite Petition 870250012175, dated 02 / 14 / 2025, page 36 / 65 29 / 49 CAS No. INCI Name Anhydrous System Melting Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Gel former 71011-26-2 / 94891-33-1 Hectorite 0.001 0.200 APPROVED -Viscosity modifier 5 / 1269160-0 Stearalkonium 108-32-7 2 Propylene Carbonate 0.001 2.000 NA UV absorber Light stabilizer -UV filter 302776-68-7 3 Diethylamino hydroxybenzoyl hexyl benzoate 1.000 9.000 NA Skin conditioner emollient 68334-28-1 4 Hydrogenated vegetable oil 0.500 5.000 NA Antioxidant 6683-19-8 5 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate 0.010 1.000 NA UV absorber Light stabilizer - UV filter 187393-00-6 6 Bis-ethylhexyloxyphenol methoxyphenyl triazine 0.500 8.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 37 / 65 30 / 49 CAS No. INCI Name Anhydrous System Melting Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) UV Absorber Light Stabilizer - UV Filter 6197-30-4 7 Octocrylene 1.000 9.000 NA UV Absorber - UV Filter 118-56-9 8 Homosalate 1.000 13.500 NA Opacifier Absorbent - Viscosity Modifier Sensory Modifier 7631-86-9 / 112945-52-5 / 60676-860 9 Silica 1.000 50.000 NA Skin Conditioner 533-75-5 10 Tropolone 0.100 1.000 NA Skin Conditioner 6920-22-5 11 1,2-Hexanediol 0.100 1.000 NA Skin Conditioner 1117-86-8 12 Caprylyl Glycol 0.100 1.000 NA Antioxidants Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopheryl Acetate 0.100 2.000 NA Emollient Skin Conditioner 14 Coco Caprylate 0.500 10.000 NA Petition 870250012175, dated 02 / 14 / 2025, page 38 / 65 31 / 49 CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Emollient Skin Conditioner 111937-03-2 16 Cetearyl Isononanoate 0.100 6.000 NA Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 17 Caprylic / Capric Triglyceride 1.000 3.500 NA Emollient Skin Conditioner 68411-27-8 18 C12-C15 Alkyl Benzoate 1.000 40.000 NA Emollient Skin Conditioner 1680-31-5 19 Dicaprylyl Carbonate 1.000 40.000 NA UV Absorber Light Stabilizer - UV Filter 70356-09-1 20 Avobenzone INCI: Butyl methoxydibenzoyl methane 0.1 4,500 NA

[0086] Test 4 was approved with stearalkonium hectorite, as this viscosity modifying agent provided experimental batch 4 with a uniform appearance, with smooth flow, no phase separation, and the possibility of industrial production. Given these positive results, formulation tests continued with other ingredients. Petition 870250012175, dated 02 / 14 / 2025, page 39 / 65 32 / 49 selected to obtain the designed balm formulation.

[0087] Tests with sensory and solid dispersibility modifier esters were carried out using different esters. The objective of the test was to verify which viscosity modifier would be the most suitable for the designed formulation (balm with a dry sensory feel, single-phase formulation), in relation to the physicochemical behavior for the combination of ingredients, in relation to the final sensory aspect, gloss of the formulation, and the sensation of oiliness, using paraffin as a reference from international literature. Example 2 - Sensory modifiers vs. emollients test Table 5 - Sensory modifier tests X emollient CETIOL CC TESTS WITH SENSORY MODIFIERS X EMOLLIENT CETIOL CC (INCI dicaprylyl carbonate) RAW MATERIAL CODE INCI NAME EMOLLIENT TEST RESULT NOTES RESULT EVALUATED 1 Covabead crystal Calcium and sodium borosilicate CETIOL CC (INCI Dicaprylyl Carbonate) Light greenish fluid Formation of sandy crystals, appearance and color Rejected 2 DRY FLO PC Octenylsuccinate Aluminum Starch CETIOL CC (INCI Dicaprylyl Carbonate) Fluid cream gel Changed viscosity and appearance Rejected 3 Gransil PSQ Polymethylsilsesquioxane CETIOL CC (INCI Carbonate) Did not gel Changed viscosity Rejected Petition 870250012175, dated 02 / 14 / 2025, p. 40 / 65 33 / 49 4 Imecare 03D Perilita CETIOL CC (INCI Dicaprylyl Carbonate) Grayish mass Changed viscosity, color and appearance Rejected 5 Imecare 25P Perilita CETIOL CC (INCI Dicaprylyl Carbonate) Crumbled Changed appearance, no gel formation, balm crumbled completely Rejected 6 Imecare 400D Diatomaceous earth different CETIOL CC (INCI Dicaprylyl Carbonate) Crumbled Changed appearance, no gel formation, balm crumbled completely Rejected 7 Marshmallow Power Crosspolymer sheet of hexylactone HDI / trimethylol and polymethyl methacrylate urethane acrylate CETIOL CC (INCI Dicaprylyl Carbonate) Ointment with high cost and plastic in the composition Very high cost, the objective is not to use PMMA, as it is a non-biosustainable plastic Rejected 8 Orgasol Caresse Polyamide-5 CETIOL CC (INCI Carbonate) Crumbled Discontinued by manufacturer Rejected Petition 870250012175, dated 02 / 14 / 2025, p. 41 / 65 34 / 49 9 Silica (INCI) CETIOL CC (INCI Dicaprylyl Carbonate) Brighter ointment, superior sensory quality compared to others, inexplicable adsorption. SPF curve with good results above 50+. Approved. High SPF curve above SPF 60. 10 Silica SI500 (INCI) CETIOL CC (INCI Dicaprylyl Carbonate) Reddish appearance, disapproved. Completely altered the product's color and appearance. Disapproved. 11 Spheron L1500 (INCI) CETIOL CC (INCI Dicaprylyl Carbonate) Sticky, gooey, greasy, oily sensory quality. Sticky, gooey, greasy sensory quality.Oily. Rejected. 12 Tospearl 14 5A Polymethylsilsesquioxane CETIOL CC (INCI Dicaprylyl Carbonate) Did not gel. Fluid changed appearance. Rejected. 13 Rice Silk Oryza Sativa husk powder or Silica or Oryza Sativa husk powder or Silica CETIOL CC (INCI Dicaprylyl Carbonate) Raw material not tested. Manufacturer cannot maintain microbiological quality. Rejected. 14 Tospearl 145a + silica SI175 Polymethylsilsesquioxane + silica CETIOL CC (INCI Dicaprylyl Carbonate) Did not perform as well as pure silica SI175. Did not have adequate viscosity. Rejected. Petition 870250012175, dated 02 / 14 / 2025, page 42 / 65 35 / 49 (Mixture due to PSQ 15 Valvance Touch 210 Silica Class (INCI) CETIOL CC (INCI Dicaprylyl Carbonate) Brighter ointment SPF curve with good results above 50+, very shiny on the skin and product REJECTED FOR PRESENTING TOO MUCH SHINE, OILY APPEARANCE ON THE SKIN. Approved only for the high SPF curve above SPF 60)

[0088] This test with cetiol cc ester (INCI Dicaprylyl carbonate) with silica (code 9) was approved in aspects such as color, odor, spreadability, in addition to providing the formulation with excellent absorption, and achieved SPF 60, as desired for the photoprotector formulation (Figure 2 and Figure 3). Table 6 - Tests with sensory modifiers X emollient C12-C15 alkyl benzoate RAW MATERIAL CODE INCI NAME EMOLLIENT TEST RESULT NOTES RESULT OF THE EVALUATED 1 COVABEAD CRYSTAL Calcium and sodium borosilicate CETIOL AB (INCI: C12-C15 alkyl benzoate) Sensory and appearance disapproved Disapproved appearance and sensory disapproved 2 DRY FLO PC Aluminum starch octanylsuccinate CETIOL AB (INCI: C12-C15 alkyl benzoate) Product too fluid Disapproved appearance Disapproved Petition 870250012175, dated 02 / 14 / 2025, page 43 / 65 36 / 49 3 GRANSIL PSQ Polymethylsilsesquioxane CETIOL AB (INCI: C12-C15 alkyl benzoate) Did not gel. Appearance rejected. 4 IMECARE 03D Perilite, different particle sizes. CETIOL AB (INCI: C12-C15 alkyl benzoate) Gray appearance, rejected. Appearance and color rejected. 5 IMECARE 25P Perilite, different particle sizes. CETIOL AB (INCI: C12-C15 alkyl benzoate) Crumbled. Appearance rejected. 6 IMECARE 400D Diatomaceous earth, different particle sizes. CETIOL AB (INCI: C12-C15 alkyl benzoate) Crumbled. Appearance rejected. 7 MASHMALLOW POWER HDI / Trimethylol hexylactone & polymethyl methacrylate (PMMA) crosspolymer sheet. CETIOL AB (INCI: C12-C15 alkyl benzoate) Ointment with high cost and plastic in its composition. Very high cost, the goal is not to use PMMA.Because it is a non-biosustainable plastic. Rejected 8 ORGASOL CARESSE Polyamide-5 CETIOL AB (INCI: C12-C15 alkyl benzoate) Crumbled. Rejected appearance. Rejected 9 SILICA Silica class (INCI) different CETIOL AB (INCI: C12-C15 alkyl benzoate) Ointment brighter, the C12-C15 conferred SPF curve with good results. Rejected appearance with, Petition 870250012175, dated 02 / 14 / 2025, p. 44 / 65 37 / 49 particle sizes C12-C15) excessive shine to the product, beyond the desired above 50+ □excessive shine, oiliness conferred by the tested ester. Approved only by the high SPF curve above SPF 60 10 SILICA SI500 Silica class (INCI) different particle sizes CETIOL AB (INCI: C12-C15 alkyl benzoate) Reddish appearance rejected Rejected appearance and color Rejected 11 SPHERON L1500 Silica class (INCI) different particle sizes CETIOL AB (INCI: C12-C15 alkyl benzoate) Sticky, gooey, greasy, oily feel Rejected appearance and feel Rejected 12 TOSPEARL 14 5A Polymethylsilsesquioxane CETIOL AB (INCI: C12-C15 alkyl benzoate) Did not gel Rejected appearance Rejected 13 RICE SILK Oryza Sativa Hull Powder or Silica CETIOL AB (INCI: C12-C15 alkyl benzoate) (C12-C15) Raw material not tested. The manufacturer cannot maintain microbiological quality. Rejects. Petition 870250012175, dated 02 / 14 / 2025, page 45 / 65 38 / 49 gica 14 TOSPEARL 14 5A + SILICA SI175 Polymethylsilsesquioxane + silica CETIOL AB (INCI: C12-C15 alkyl benzoate) Did not perform as well as pure SI175 silica. Failed in terms of appearance and feel. Failed. 15 valance touch 210 Silica class (INCI) different particle sizes CETIOL AB (INCI: C12-C15 alkyl benzoate) More shiny ointment, the C12-C15 gave the product too much shine, beyond what was desired. SPF curve with good results above 50+. Failed due to excessive shine, oiliness conferred by the tested ester. Approved only for the high SPF curve above SPF 60.

[0089] The sensory modifier tests X emollient cetiol CC (INCI dicaprylyl carbonate - table 5) and C12-C15 alkyl benzoate (table 6) showed satisfactory results regarding the physicochemical aspects (color, odor and spreadability) together with the silica particle size chosen for the formulation.

[0090] However, the formulation with dicaprylyl carbonate (table 5) performed better than the formulation with C12-C15 alkyl benzoate (table 6) due to the increase in Petition 870250012175, dated 02 / 14 / 2025, page 46 / 65 39 / 49 photoprotection efficacy and SPF values ​​(above 60). Therefore, it is concluded from these tests that the SPF efficacy, sensory and performance results of the formula with dicaprylyl carbonate were superior in the same anhydrous base formula system compared to the formula containing C12-C15 alkyl benzoate. Example 3 - Melting and dispersion test of solids

[0091] The solid fusion and dispersion test was carried out with the aim of understanding the melting points and dispersion of each component, as well as the homogeneity of the product so that there would be no recrystallization and lack of physicochemical stability such as changes in color, appearance and odor.

[0092] For this purpose, 2 galenic batches were manufactured, in which the liquid raw materials were added to a suitably sized, clean and dry container. Each batch was heated to a temperature of 87°C to 90°C. The solid raw materials, in powder form, were then added, with the exception of the sensory modifier, until complete fusion and dispersion. Next, each batch was cooled to a temperature of 60°C, and the sensory modifier that obtained the best result in the Example 1 test, stearalkonium hectorite, was added. Finally, each batch was cooled to room temperature and subsequently packaged.

[0093] For the melting and dispersion test of galenic batches 1 and 2, the raw materials were heated from 87°C to 90°C on a heating plate and the temperature was controlled with a calibrated thermometer during high-speed homogenization from 1500 to 3000 rpm. Table 7 - Melting and dispersion test of solids for galenic batch 1 Petition 870250012175, dated 02 / 14 / 2025, page 47 / 65 40 / 49 Function CAS No. INCI Name Anhydrous System Melting Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Gel former - Viscosity modifier 71011-26-2 / 94891-33-5 / 12691-60-0 1 Stearalkonium hectorite 0.001 0.200 Approved Viscosity modifier Solvent 108-32-7 2 Propylene carbonate 0.001 2.000 Approved UV absorber - Light stabilizer - UV filter 302776-68-7 3 Diethylamino hydroxybenzoyl hexyl benzoate 1.000 9.000 Approved Skin conditioner Skin conditioner - emollient 68334-28-1 4 Hydrogenated vegetable oil 0.500 5.000 Approved Antioxidant 6683-19-8 5 Pentaerythrityl Tetra-dit-butyl Hydroxyhydrocinnamate 0.010 1.000 Approved UV absorber - Light stabilizer - UV filter 187393-00-6 6 Bisethylhexyloxyphenyl methoxyphenyl triazine 0.500 8.00 Approved Petition 870250012175, dated 02 / 14 / 2025, page 48 / 65 41 / 49 Function No. CAS Name INCI Anhydrous System Melting Result % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) UV Absorber - Light Stabilizer - UV Filter 6197-30-4 7 Octocrylene 1.000 9.000 Rejected due to being a globally controversial filter UV Absorber - UV Filter 118-56-9 8 Homosalate 1.000 13.500 Rejected due to being a globally controversial filter Opacifier Absorber - Viscosity Modifier Sensory Modifier 7631-86-9 / 112945-52-5 / 60676-86-0 9 Silica 1.000 50.000 Approved Skin Conditioner 533-75-5 10 Tropolone 0.100 1.000 Approved Skin Conditioner 6920-22-5 11 1,2-Hexanediol 0.100 1.000 Approved Skin Conditioner 1117-86-8 12 Caprylyl Glycol 0.100 1.000 Approved Antioxidants Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopheryl Acetate 0.100 2.000 Approved Skin Conditioner - emollient _ 14 Coco Caprylate 0.500 10.000 Approved Skin Conditioner 111937-03- 0.100 6.000 Approved Petition 870250012175, dated 02 / 14 / 2025, page 49 / 65 42 / 49 Function No. CAS NAME INCI System Anhydrous Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Skin - Skin Conditioner — emollient 2 16 Cetearyl isononanoate Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 17 Caprylic / Capric Triglyceride 1.000 3.500 Approved Skin Conditioner - emollient 68411-27-8 18 C12C15 Alkyl Benzoate 1.000 40.000 Approved, but with excessive shine Skin Conditioner - emollient 1680-31-5 19 Dicaprylyl Carbonate 1.000 40.000 Approved Absorbent UV Light Stabilizer - UV Filter 70356-09-1 20 Avobenzone INCI: Butyl methoxydibenz oleomethane 0.1 4,500 Approved UV Absorber - Light Stabilizer - UV Filter 88122-99-0 21 Ethylhexyl triazone 0.1 4,500 Approved qsp _ _ 100% 100% Approved

[0094] In galenic batch 1, some raw materials homogenized, namely: octocrylene, homosalate and oil Petition 870250012175, dated 02 / 14 / 2025, pages 50 / 65 43 / 49 hydrogenated vegetable.

[0095] Regarding sensory and olfactory aspects, the photoprotective balm remained homogeneous, smooth, without lumps, with an absence of foreign particles and with the characteristic odor of a photoprotector; however, galenic batch 1 failed the sensory efficacy test, as it maintained undesirable stickiness and softness, as well as a greasy appearance.

[0096] For visual evaluation, the photoprotector formulation was placed on a clean, dry glass plate, and it was observed that there was no color change in the raw materials of the formulation from galenic batch 1, maintaining the yellow / light yellow color for all raw materials.

[0097] Although the ingredients octocrylene and homosalate homogenized in the formulation for galenic batch 2, they were not added to the final formulation because they did not align with the designed concept of a photoprotective formulation being environmentally sustainable, without the use of microplastics or non-biodegradable agents. C12-C15 alkyl benzoate was also not added to the formulation, since its performance in the formulation, although good, was inferior to dicaprylyl carbonate, the latter being selected for use in galenic batch 2. Table 8 - Melting and dispersion test of solids for galenic batch 2 Petition 870250012175, dated 02 / 14 / 2025, pp. 51 / 65 44 / 49 Function CAS No. INCI Name Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Gel former - Viscosity modifier 71011-26-2 / 94891-33-5 / 12691-60-0 1 Stearalkonium hectorite 0.001 0.200 Approved Viscosity modifier Solvent 108-32-7 2 Propylene carbonate 0.001 2.000 Approved UV absorber - Light stabilizer - UV filter 302776-68-7 3 Diethylamino hydroxybenzyl oil hexyl benzoate 1.000 9.000 Approved Skin conditioner Skin conditioner - emollient 68334-28-1 4 Hydrogenated vegetable oil 0.500 5.000 Approved Antioxidant 6683-19-8 5 Pentaerythrityl Tetradi-t-butyl Hydroxyhydrocinnamate 0.010 1.000 Approved UV absorber - Light stabilizer - UV filter 187393-00-6 6 Bisethylhexyloxyphenol methoxyphenyl triazine 0.500 8.000 Approved Petition 870250012175, dated 02 / 14 / 2025, pages 52 / 65 45 / 49 Function No. CAS NAME INCI System Anhydrous Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Opacifier Absorbent - Viscosity modifier Sensory modifier 7631-86-9 / 112945-52-5 / 60676-86-0 9 Silica 1.000 50.000 Approved homogenized Skin Conditioner 533-75-5 10 Tropolone 0.100 1.000 Approved homogenized Skin Conditioner 6920-22-5 11 1,2-Hexanediol 0.100 1.000 Approved homogenized Skin Conditioner 1117-86-8 12 Caprylyl Glycol 0.100 1. 000 Approved fully melted Antioxidants - Skin Conditioner 7695-91-2 / 58-95-7 13 Tocopherol Acetate 0.100 2.000 Approved fully melted Skin Conditioner - emollient _ 14 Coconut Caprylate 0.500 10.000 Approved fully melted Skin Conditioner - emollient 111937-03-2 16 Cetearyl Isononanoate 0.100 6.000 Approved fully melted Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 17 Caprylic / Capric Triglyceride 1.000 3.500 Approved Petition 870250012175, dated 02 / 14 / 2025, pp. 53 / 65 46 / 49 Function No. CAS Name INCI Anhydrous System Melting Point % by weight SPF 50+ Min (range) % by weight SPF 50+ Max (range) Skin Conditioner - Emollient 1680-31-5 19 Dicaprylyl Carbonate 1.000 40.000 Approved UV Absorber - Light Stabilizer - UV Filter 70356-09-1 20 Avobenzone INCI: Butyl methoxydibenzoylmethane 0.1 4.500 Approved UV Absorber - Light Stabilizer - UV Filter 88122-99-0 21 Ethylhexyl Triazone 0.1 4.500 Approved qsp _ _ 100% 100%

[0098] Galenic batch 2 was manufactured by first adding pentaerythrityl tetradi-t-butyl hydroxyhydrocinnamate to the liquid components and homogenizing for 20 to 50 minutes. Then, hot vegetable oil was added and the mixture was homogenized again for 20 to 50 minutes. Subsequently, hectorite was added at a temperature between 80°C and 85°C until completely homogenized. Finally, all the sunscreens, avobenzone, ethylhexyl triazone, and diethylaminohydroxybenzoyl hexyl benzoate, were added at a melting temperature between 85°C and 87°C. This process had positive results for all raw materials; that is, all homogenized, there was no formation of lumps, and the balm formulation... Petition 870250012175, dated 02 / 14 / 2025, pages 54 / 65 47 / 49 of the sunscreen obtained a smooth appearance, free of foreign particles, with the characteristic odor of sunscreen, and with a pleasant, dry feel. Furthermore, in the visual evaluation test, the sunscreen formulation was placed on a clean, dry glass plate (Figure 1, Figure 2, and Figure 3), and it was observed that there was no color change in the raw materials of the formulation from galenic batch 1, maintaining the yellow / light yellow coloration for all raw materials.

[0099] Finally, the hydrophobic test was carried out, in which water was sprayed after applying the sunscreen to the skin of a volunteer in order to verify water repellency, and the sunscreen passed this test.

[00100] Furthermore, batch 2 showed better sensory aspects and homogeneity compared to batch 1, passing the sensory efficacy test, i.e., with surprising softness, smoothness and drying time, and did not show stickiness or a greasy appearance. EXAMPLE 4— Modifier Formulation of an anhydrous sunscreen with a dry, velvety feel and rapid absorption.

[00101] Given the positive and surprising results of the formulation of galenic batch 2, it was chosen to be the embodiment of the formulation of the anhydrous photoprotector with a dry, velvety touch and rapid absorption of the present invention, disclosed here in Example 4, which defines the preferred concentrations, but without restricting the scope of the invention now proposed. Table 9 - Photoprotective balm formulation Function No. CAS No. INCI Name Concentration (% by weight) Gel former 71011-26-2 / 94891-33- 5 / 12691- Stearalkonium hectorite viscosity modifier 60-0 108-32-7 0.1125 Petition 870250012175, dated 02 / 14 / 2025, pages 55 / 65 48 / 49 Viscosity - Solvent Propylene Carbonate UV Absorber Light Stabilizer UV Filter 302776-68-7 Diethylaminohydroxybenzoyl hexyl benzoate 5.0000 Skin Conditioner - Emollient 68334-28-1 Hydrogenated Vegetable Oil 3.5000 Antioxidant 6683-19-8 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate 0.1000 UV Absorber Light Stabilizer - UV Filter 187393-00-6 Bis-ethylhexyloxyphenol methoxyphenyl triazine 7.0000 Opacifier Absorbent Viscosity Modifier Sensory Modifiers 7631-86-9 / 112945-52-5 / 60676-86-0 Silica 33.0000 Skin Conditioner 533-75-5 Tropolone 0.0075 Skin Conditioner 6920-22-5 1,2-Hexanediol 0.49625 Skin Conditioner 1117-86-8 Caprylyl Glycol 0.49625 Antioxidants Skin Conditioner 7695-91-2 / 58-95-7 Tocopheryl Acetate 0.2000 Skin Conditioner - Emollient - Coconut Caprylate 6.5000 Skin Conditioner - Emollient 111937-03-2 Cetearyl Isononanoate 1,0000 Solvent - Skin Conditioner 73398-61-5 / 65381-09-1 Caprylic / Capric Triglyceride 3,125 Skin Conditioner Skin Conditioner - Emollient 1680-31-5 Dicaprylyl Carbonate 30,2000 UV Absorber - Light Stabilizer - UV Filter 70356-09-1 Avobenzone - Butyl Methoxydibenzoylmethane 4,500 UV Absorber - Light Stabilizer - UV Filter 88122-99-0 Ethylhexyl triazone 4,500 Petition 870250012175, dated 02 / 14 / 2025, pages 56 / 65 49 / 49 total _ _ 100%

[00102] Surprisingly, it was found that adding dicaprylyl carbonate results in an increase in the SPF system, and the product performs better in terms of effectiveness, appearance, and feel when compared to the C12C15 alkyl benzoate formula.

[00103] Regarding the Absorbent System, unexpected results were obtained, finding that, by adding the adsorbents from the tests in Examples 1 to 3, and depending on their particle size, the film formation on the skin, as well as the sensory aspect, color and odor, an increase in effectiveness is obtained. Therefore, a product with better performance in efficiency, appearance and sensory aspects when compared to the formulas tested and studied was obtained. Given the variety of esters on the market, dicaprylyl carbonate was chosen, which, together with the sensory modifier silica, brought excellent homogeneity and stability to the formula as well as a surprising sensory experience.

[00104] It should be understood that the present description does not limit the application to the details described herein and that the invention is capable of other embodiments and of being practiced or performed in a variety of ways, within the scope of the claims. Although specific terms have been used, such terms should be interpreted in a generic and descriptive sense, and not for the purpose of limitation. Petition 870250012175, dated 02 / 14 / 2025, pp. 57 / 65

Claims

1 / 4 CLAIMS 1. HIGH-PERFORMANCE ANHYDROUS PHOTOPROTECTOR characterized by comprising: a) UV absorber, which functions as a sunscreen; b) emollients, which function as a skin conditioner; c) sensory modifiers or absorbent agents; d) viscosity modifiers, which function as a gel former and solvent and thickening agent; ee) antioxidants.

2. PHOTOPROTECTOR, according to claim 1, characterized in that the UV absorbers are selected from the group comprising: diethylaminohydroxybenzoyl hexyl benzoate, diethylhexyl butamido triazone, butyl methoxydibenzoylmethane, bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl triazone, cinnamates and triazines.

3. Photoprotector, according to claim 2, characterized in that butyl methoxydibenzoylmethane is present in 1.000% to 5.000% of the composition.

4. Photoprotector, according to claim 2, characterized in that ethyl hexyl triazone is present in 1.000% to 5.000% of the composition.

5. Photoprotector, according to claim 2, characterized in that bis-ethylhexyloxyphenol methoxyphenyl triazine is present in 0.500% to 8.000% of the composition.

6. PHOTOPROTECTOR, according to claim 2, characterized in that diethylamino hydroxybenzoyl hexyl benzoate is present in 1.000% to 9.000% of the composition.

7. PHOTOPROTECTOR, according to claim 1, Petition 870250012175, dated 02 / 14 / 2025, page 58 / 65 2 / 4 characterized in that the emollients are selected from the group comprising dicaprylyl carbonate, C12-C15 alkyl benzoate, cetearyl isononanoate, coco caprylate, undecane and tridecane, caprylic triglyceride, hydrogenated vegetable oil, tropolone, 1,2-hexanediol, tropolone, 1,2-hexanediol and caprylyl glycol.

8. PHOTOPROTECTOR, according to claim 7, characterized in that the emollients are preferably cetearyl isononanoate, dicaprylyl carbonate, caprylic triglyceride, hydrogenated vegetable oil, tropolone, 1,2-hexanediol, coconut caprylate and caprylyl glycol.

9. Photoprotector, according to claim 8, characterized in that coconut caprylate is present from 0.500 to 10.000%.

10. PHOTOPROTECTOR, according to claim 8, characterized in that cetearyl isononanoate is present from 0.100 to 6.000%, preferably 0.5% to 2.5% of the composition.

11. PHOTOPROTECTOR, according to claim 8, characterized in that dicaprylyl carbonate is present in 1.000 to 40.000%, preferably 20% to 35% of the composition.

12. PHOTOPROTECTOR, according to claim 8, characterized in that caprylic triglyceride is present in 1.000 to 3.500% of the composition.

13. PHOTOPROTECTOR, according to claim 8, characterized in that hydrogenated vegetable oil is present from 0.500 to 5.000%, preferably 2.500% to 5.000% of the composition.

14. PHOTOPROTECTOR, according to claim 8, characterized in that tropolone is present from 0.100 to 1.000%, preferably 0.001 to 0.150% of the composition.

15. PHOTOPROTECTOR, according to claim 8, Petition 870250012175, dated 02 / 14 / 2025, page 59 / 65 3 / 4, characterized in that 1,2-hexanediol is present from 0.100 to 1.000%, preferably 0.200 to 1.000% of the composition.

16. PHOTOPROTECTOR, according to claim 8, characterized in that caprylyl glycol is present from 0.100 to 1.000%, preferably 0.250 to 1.000% of the composition.

17. PHOTOPROTECTOR, according to claim 1, characterized in that the absorbents are selected from the group comprising calcium and sodium borosilicate, aluminum starch octenylsuccinate, polymethylsilsesquioxane 1, perlite 1 with a particle size of 3 µm, perlite 2 with a particle size of 25 µm, perlite 3 with a particle size of 400 µm, HDI / Trimethylolhexyl / trimethylol polymethylmethacrylate (PMMA) crosspolymer sheet, polyamide-5, silica class 1 (INCI) with a particle size of 10 to 14 µm, silica class 2 (INCI) with a particle size of 7 µm, silica class 3 (INCI) with a particle size of 6 µm, silica class 4 (INCI) with a particle size of 6 to 15 µm, polymethylsilsesquioxane 2, powdered Oryza sativa bark or silica, polymethylsilsesquioxane + silica.

18. PHOTOPROTECTOR, according to claim 17, characterized in that the viscosity modifiers are stearalkonium hectorite, propylene carbonate and silica.

19. PHOTOPROTECTOR, according to claim 18, characterized in that propylene carbonate is present from 0.001 to 2.000%, preferably 0.050 to 0.800% of the composition.

20. PHOTOPROTECTOR, according to claim 18, characterized in that stearalkonium hectorite is present from 0.001 to 0.200%, preferably 0.050 to 0.800% of the composition.

21. PHOTOPROTECTOR, according to claim 18, characterized in that silica is present in 1.000 to 50.000% of the composition. Petition 870250012175, dated 02 / 14 / 2025, pp. 60 / 65 4 / 4 22. PHOTOPROTECTOR, according to claim 1, characterized in that the antioxidant is selected from the tocopherol acetate group and pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, HT, BHA, ascorbic acid, palmityl ascorbate.

23. PHOTOPROTECTOR, according to claim 22, characterized in that tocopherol acetate is present from 0.100 to 2.000%, preferably 0.050 to 1.000% of the composition.

24. PHOTOPROTECTOR, according to claim 22, characterized in that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is present from 0.010 to 1.000%, preferably 0.050 to 0.900% of the composition.

25. Photoprotector, characterized by the fact that it is in the pharmaceutical form of a solid or semi-solid.

26. PHOTOPROTECTOR, according to claim 22, characterized in that the pharmaceutical form of a solid or semi-solid is an ointment.

27. SUNSCREEN, characterized by the fact that the sun protection factor (SPF) of the composition is at least 50. Petition 870250012175, dated 02 / 14 / 2025, pp. 61 / 65

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