WO2019036774A1

WO2019036774A1 - Repellent sunscreen composition, use of a composition and method of protecting a keratinous substrate

Info

Publication number: WO2019036774A1
Application number: PCT/BR2017/050246
Authority: WO
Inventors: Patricia TRAJANO; Marina Castello ESPOSITO; Angeles FONOLLA-MORENO
Original assignee: L'oreal
Priority date: 2017-08-25
Filing date: 2017-08-25
Publication date: 2019-02-28
Also published as: BR112020003748A2; BR112020003748B1

Abstract

The present invention is directed to a repellent sunscreen composition, which comprises an association of a UV filter system, an emulsifying system and N,N-diethyl-m-toluamide (DEET) and its uses.

Description

REPELLENT SUNSCREEN COMPOSITION, USE OF A COMPOSITION AND METHOD OF PROTECTING A KERATINOUS SUBSTRATE FIELD OF THE INVENTION

The present invention is directed to a sunscreen composition with repellent action, which comprises an association of a specific UV filter system, a specific emulsifying system and N,N-diethyl-m-toluamide (DEET) and its uses.

BACKGROUND OF THE INVENTION

The photoprotection of keratinous substrates, including both skin and hair, is considered of great importance in order to protect from sun-damage, sunburn, photo-aging, as well as to decrease the chances of skin cancer development caused by exposure to ultraviolet ("UV") radiation. There are typically two types of UVA/UVB sunscreen compositions used to accomplish photoprotection, namely, inorganic UV filters and organic UV filters.

The UVB radiation causes skin reddening and sunburn, tends to damage the skin more superficial epidermal layers. It plays a key role in the development of skin cancer and a contributory role in tanning and photoaging.

The UVA radiation is the dominant tanning ray, and we now know that tanning, whether outdoors or in a salon, causes cumulative damage over time. A tan result from injury to the skin's DNA; the skin darkens in an imperfect attempt to prevent further DNA damage. These imperfections, or mutations, can lead to skin cancer.

The long UVA radiations are the less energetic UVA radiation and therefore, they were considered as "less dangerous". But they are numerous in our environment, as they represent more than 75% of UV rays reaching earth. So it is worth studying their skin impact as they will be repeated every day for a long period of time.

Thus, the UV filters may either protect against UVA radiation (longwave), UVB radiation (shortwave), or both. In the past, it was commonly held that protection against UVB radiation was the primary or even sole consideration in sun- protection. However, more recent research has revealed that exposure to UVA radiation may also be dangerous and lead to undesirable effects. As such, the current trend in sun-protection endeavors is typically to protect against both UVA and UVB in a single composition, and to increase both the Sun Protection Factor ("SPF") and the UVA ratings of the composition. The degree of UV protection afforded by a sunscreen composition is directly related to the amount and type of UV filters contained therein. The higher the amount of UV filters, the greater the degree of UV protection.

Thus, many sunscreen compositions have been proposed to overcome the effects induced by UVA and/or UVB radiation. They generally contain organic or mineral UV-screening agents, which function according to their own chemical nature and according to their own properties by absorption, reflection or scattering of the UV radiation. Also, they generally contain mixtures of liposoluble organic screening agents and/or of water-soluble UV-screening agents combined with metal oxide pigments such as titanium dioxide or zinc oxide. The sunscreen compositions having UVA or UVB or UVA/UVB filter systems commonly used in the sunscreen cosmetic market are generally in the form of oil, an oil-in-water emulsion (stabilized dispersion of an oily phase in an aqueous phase) or a water-in-oil emulsion (stabilized dispersion of an aqueous phase in an oily phase) comprising at least one oily phase comprising solvents and oils.

With respect the tropical countries, the high temperatures and longtime of UV radiation exposures are also associated with suitable conditions for the proliferation of mosquitos that can cause many types of diseases such as Dengue, Chikungunya, Zica, Febre Amarela, among others.

Furthermore, substantial dengue fever outbreaks prevail each year in tropical countries. Consistently during the last five years (2010-2014), dengue incidence has ranged from approximately 1 to 2 million cases per year. D uring 2013, the American region reported the highest historical case numbers with over 2.3 million, including 37,898 that presented as severed dengue and 1318 deaths with a 0.055% case-fatality rate (PAHO, 2014; PAHO, 2015a).

Therefore, it is desirable to formulate a sunscreen composition capable of not only to achieve high SPF rating, but also providing protection against mosquitos that can cause damage to the health of the human population.

There have been attempts to provide a single product which provides sunscreen protection and insect repellent protection (see US patent 3,186,912, WO 94/00104, US patent 5,575,988, US patent 5,716,602 and US patent publication 2003/0072782), however, none of the prior arts disclose a composition with high SPF protection. Also, as stated by the US patent publication 2003/0072782, seeking a stable repellent sunscreen composition requires a carefully selected use of emulsifiers. Such statement demonstrates the difficulty of reaching a stable and effective repellent and SPF composition.

An unstable composition will directly impact the effectiveness of the insect repellent active ingredient, for example, diethyl toluaminde, " DEET", and the UV filter system.

DEET is a broad spectrum topical insect repellent against mosquitos, flies, fleas, ticks and other biting insects. It has been widely used to protect humans and animals from the attack of such insects for the past 40 years (Anon, 1980, Pesticide Registration Standard-DEET. U.S. Environmental Protection Agency, Washington DC and Taylor, W.G., Danielson, T.J. , Spooner, R.W., Golsteyn, L.R., 1994. Pharmacokinetic assessment of the dermal absorption of N,N-diethyl-m- toluamide (DEET) in cattle. Drug Metab. Dispos. 22, 106-1 12).

DEET provides an invisible, long-lasting and thin film on the skin and has excellent perspiration, wash-off and wipe-off resistance. However, such compound presents strong odor and has a lipophilic characteristic.

Thus, in view of the lipophilic characteristic and strong odor, when combining such ingredients with sunscreen agents, there is a great chance of encountering problems with the stability of the composition and unpleasant smell for the customer.

Therefore, the challenge of formulating such an association (UV filter system and DEET) is to maintain the stability and effectiveness of the ingredients in the composition, since both active ingredients tend to have their actions or efficacies decreased when they are associated.

Thus, the inventors succeeded to overcome the problems of the state of the art and surprisingly revealed/discovered a stable sunscreen composition with high SPF and effective repellent action, good odor and sensorial benefits, by the combination of a UV filter system, an emulsifying system and DEET.

SUMMARY OF THE INVENTION

The present invention is directed to provide a composition with dual benefits i.e., a stable sunscreen composition with high SPF associated with a repellent action, which comprises a combination of (a) a specific UV filter system, (b) a specific emulsifying system and (c) DEET; and its uses. The composition of the invention presents effective repellent protection jointly with a high level of UV-protection associated with good odor and sensorial benefits.

DETAILED DESCRIPTION OF THE INVENTION

The sunscreen composition with repellent action of the present invention comprises:

(a) a UV filter system comprising a mixture of terephthalylidene dicamphor sulfonic acid, octocrylene and butyl methoxydibenzoylmethane;

(b) an emulsifying system comprising a mixture of glyceryl stearate (and) PEG-100 stearate, potassium cetyl phosphate and stearyl alcohol ; and

(c) a repellent agent chosen from N,N-diethyl-m-toluamide (DEET). The composition according to the invention provide excellent sensorial performance as well as surprisingly high SPF values and product stability.

The pH of the repellent sunscreen composition of the invention is preferably within the range of about 6.1 to about 7.1 , more preferably, of about 6.6.

The density of the repellent sunscreen composition of the invention is preferably within the range of about 0.9 g/cm³ to about 1 .1 g/cm³, more preferably, of about 1 .0 g/cm³.

The viscosity of the repellent sunscreen composition of the invention is preferably within the range of about 636 rnPas to about 1265 mPa.s, more preferably, of about 790 to about 970 mPa.s, even more preferably of about 834 to about 958 rnPas.

Furthermore, the sunscreen composition with repellent action of the present invention may present a Sun Protection Factor ranging from 40 to 90.

In various embodiments, the sunscreen composition with repellent action of the present invention may present a Sun Protection Factor of 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90.

In an embodiment, the sunscreen composition with repellent action of the present invention may present a Sun Protection Factor of 40.

In an embodiment, the sunscreen composition with repellent action of the present invention may present a Sun Protection Factor of 90.

Both the Sun Protection Factor 40 and 90 means that if one burns in the sun after 1 0 minutes with no sunscreen, it will take forty or ninety times longer to burn equivalent^ when the product is applied as directed. The repellent sunscreen composition of the invention is in the form of an oil in water (O/W) emulsion.

According to a preferred embodiment, the composition of the invention is hypoallergenic. "Hypoallergenic" as used herein, refers to a composition with reduced allergenic potential.

The repellent sunscreen composition of the invention can be used as a daily product for the skin. Therefore, the composition of the invention may be used as sunscreen and repellent.

In a preferred embodiment, the composition of the invention is for the manufacture of a product for preventing sunburns and insect bites.

Terms

As used herein, the expression "at least one" means one or more and thus includes individual components as well as mixtures/combinations.

Other than in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients and/or reaction conditions are to be understood as being modified in all instances by the term "about," meaning within +/- 5% of the indicated number.

As used herein, all ranges provided are meant to include every specific range within, and combination of sub ranges between, the given ranges. Thus, a range from 1 -5, includes specifically 1 , 2, 3, 4 and 5, as well as sub ranges such as 2-5, 3-5, 2-3, 2-4, 1 -4, etc. All ranges and values disclosed herein are inclusive and combinable. For examples, any value or point described herein that falls within a range described herein can serve as a minimum or maximum value to derive a subrange, etc.

The expression "cosmetically/dermatologically acceptable" means that the item in question is compatible with any keratinous substrate. For example, "cosmetically acceptable carrier" means a carrier that is compatible with any keratinous substrate.

UV Filter System

The suitable UV filter system of the present invention comprises terephthalylidene dicamphor sulfonic acid, octocrylene and butyl methoxydibenzoylmethane, which are preferably known as Mexoryl™ SX and UV System, respectively. According to the invention, the concentration of the mixture of sunscreen/UV filters in the system may be between about 5% to about 35%, preferably between about 7% to about 30% and even more preferably between about 10 to about 29% by weight of the total weight of the composition.

In various embodiments, the concentration of the mixture of sunscreen filters in the system may be between about 7% to 30%, such as from between about 10% to about 26%, or such as from between about 1 5% to about 30%, by weight of the total weight of the composition.

In various embodiments, the concentration of the sunscreen filter chosen from terephthalylidene dicamphor sulfonic acid is between about 0.1 % to 10%, such as from between about 0.2% to about 5%, or such as from between about 0.3% to about 3%, by weight of the total weight of the composition.

In various embodiments, the concentration of the sunscreen filter chosen from octocrylene is between about 0.1 % to 10%, such as from between about 0.2% to about 5%, or such as from between about 0.5% to about 5%, by weight of the total weight of the composition.

In various embodiments, the concentration of the sunscreen filter chosen from butyl methoxydibenzoylmethane is between about 0.1 % to 10%, such as from between about 0.2% to about 5%, or such as from between about 0.5% to about 5%, by weight of the total weight of the composition.

Emulsifying System

The suitable emulsifying system of the present invention comprises emulsifying agents comprising glyceryl stearate (and) PEG-100 stearate, potassium cetyl phosphate and stearyl alcohol. Glyceryl stearate (and) PEG-100 stearate is commercially available under the tradename H/E ARLACEL 165 (from Croda). Potassium cetyl phosphate is commercially available under the tradename AMPH ISOL K (from DSM Nutritional Products). Stearyl alcohol is commercially available, for example, under the tradenames LANETTE 18 (BASF) or ECOROL (EcoGreen Oleachemicals) or KALCOL 8098 (Kao).

The emulsifying agents may be present at a concentration of about

0.1 % to about 5%, preferably of about 0.2% to about 4% and even more preferable between about 0.5 to about 3.5% by weight of the total weight of the composition.

In various embodiments, the concentration of the emulsifying agents comprising glyceryl stearate (and) PEG-100 stearate is between about 0.1 % to 10%, such as from between about 1 % to about 8%, or such as from between about 1 .8% to about 5%, by weight of the total weight of the composition. In an embodiment, the weight ratio of glyceryl stearate to PEG-100 stearate is about 1 .

In various embodiments, the concentration of the emulsifying agents comprising potassium cetyl phosphate is between about 0.1 % to 10%, such as from between about 0.5% to about 8%, or such as from between about 1 % to about 5%, by weight of the total weight of the composition.

In various embodiments, the concentration of the emulsifying agents comprising stearyl alcohol is between about 0.1 % to 5%, such as from between about 0.2% to about 4%, or such as from between about 0.5% to about 3%, by weight of the total weight of the composition.

Repellent Agent

The suitable insect repellent of the present invention is N,N-diethyl toluamide (DEET, also known by the INCI name of diethyl toluamide), which is relatively safe and provides a broad spectrum of repellency (i.e., most mosquitoes strains, ticks, sand flies, among others).

The repellent agent may be present at a concentration of about 2% to about 10%, preferably between about 3% to about 7%, more preferable between about 3.5 to about 6%, and even more preferable between about 3.5 to about 5.5% by weight of the total weight of the composition.

In some embodiments, repellent agent may be present at a concentration of about 2%, 2.5%, 3%, 3.5%, 3.75%, 4%, 4.5%, or 5% by weight of the total weight of the composition.

Additional Ingredients

In addition to the essential components described hereinbefore, the composition of the invention may further comprise any usual cosmetically acceptable ingredient, which may be chosen especially from such as additional sunscreens, perfume/fragrance, polymers, preserving agents, solvents, actives, surfactants, fat materials, vitamins, fillers and mixtures thereof.

A person skilled in the art will take care to select the optional additional ingredients and/or the amount thereof such that the advantageous properties of the composition according to the invention are not, or are not substantially, adversely affected by the envisaged addition. Suitable additional sunscreens may be lipophilic or hydrophilic. They may be organic or inorganic. Non-limiting examples of additional sunscreen agents which can be used in accordance with the invention include ethylhexyl salicylate, homosalate ethylhexyl triazone, silica, titanium dioxide, bis-ethylhexyloxyphenol methoxyphenyl triazine, methylene bis-benzotriazolyl tetramethylbutylphenol, drometrizole trisiloxane, polyglyceryl-10 laurate and mixtures thereof.

Suitable polymers include, but are not limited to, synthetic wax, C10-30 alkyl acrylate crosspolymer and mixtures thereof.

Non-limiting example of preserving agent which can be used in accordance with the invention include phenoxyethanol.

Suitable solvents include, but are not limited to water, alcohols, glycols and polyols such as glycerin, caprylyl glycol, pentylene glycol, propylene glycol, butylene glycol, and mixtures thereof.

In various embodiments, the solvent is present in a concentration from about 15 to 00% by weight, or from about 20 to about 80% by weight, or from about 30 to about 70% by weight, or from about 35 to about 75% by weight, or preferably from about 40 to about 70% by weight, and more preferably from about 45 to about 65% by weight, including ranges and sub-ranges therebetween, based on the total weight of the combinations and/or compositions of the present disclosure.

Suitable additional actives include, but are not limited to, disodium

EDTA, triethanolamine, and mixtures thereof.

In addition to the emulsifying agents of the present disclosure, surfactants may also be used in the compositions of the present invention non- limiting examples of surfactants suitable for use are fatty acids, glyceryl esters in addition to glyceryl stearate, alkoxylated fatty alcohols, such as stearic acid, laureth- 12, glyceryl isostearate, and mixtures thereof.

Exemplary fat or oil materials include, but are not limited to, esters, fatty acids, synthetic oils, and hydrocarbons/paraffins, such as stearyl alcohol, myristic acid, palmitic acid, silicones mineral oil, plant/vegetable oils, and mixtures thereof.

Non-limiting example of vitamins suitable for the composition of the present invention includes tocopherol.

The additional ingredients may represent from 60% to 85%, such as from 60%to 82% or such as from 65 to 80% by weight of the total weight of the composition. By way of non-limiting illustration, the invention will now be described with reference to the following examples.

EXAMPLES

Examples 1 to 5

A suitable composition of the invention is as Examples 1 to 4. Example

5 is considered the starting composition of the invention, as follows:

Phase FUNCTION/COMPOUNDS Ex. 1 Ex. 2 Ex. 3 Ex. 4 Ex. 5

ACTIVE COMPOUND 5.65 4.4 5.65 4.4 0.55

B DISODIUM EDTA A TRIETHANOLAMINE A DIETHYL TOLUAMIDE^*

FATTY COMPOUND 0.5 0.5 0.5 0.5 0.5

A STEARYL ALCOHOL

FILLER 1 1 1 1 1

D TALC

E FRAGRANCE 0.8 0.8 0.8 0.8 0.8

POLYMER 1.3 1.3 1 .3 1.3 1.2

C ACRYLATES/C1 0-30 ALKYL

ACRYLATE CROSSPOLYMER A SYNTHETIC WAX

PRESERVATIVE 0.7 0.7 0.7 0.7 0.7

B PHENOXYETHANOL

SILICON 1 1 1 1 1

C CYC LOH EXAS I LOXANE

SOLVENT QS 100 QS 100 QS 100 QS 100 3S 100

E ALCOHOL B WATER B GLYCERIN A CAPRYLYL GLYCOL

UV FILTER SYSTEM 10.9 10.9 10.9 10.9 10.9

A BUTYL

METHOXYDIBENZOYLMETHANE A TEREPHTHALYLIDENE DICAMPHOR SULFONIC ACID

^{* *} N,N-diethyl-m-toluamide (DEET), commercially available from the company Clariant

Example 6

A non-limiting example regarding the preparation of the composition of Example 3, could be as follows:

(1 ) Adding the oil phase A in a main recipient, heating it up to 75 ^QC;

(2) Adding the aqueous phase B in a recipient, mixing it until the complete homogenization at room temperature;

(3) Adding step (2) into step (1 ). The emulsifier will be added subsequently, mixing it well;

(4) Adding phase C into step (3) and, subsequently, proceed with the neutralization;

(5) Adding phase D into step (4), mixing it well in order to avoid fillers agglomeration;

(6) Adding phase E into step (5) at a temperature of below 30 ^QC, gradually and mixing well.

Example 7 An in vitro study was conducted in order to evaluate the UVA Protection (SPF) and wave-length of the composition of Example 3, which was applied in a standardized quantity on Sunplates PMMA, according to the ISO 24443 Cosmetics Sun protection test methods - Determination of sunscreen UVA photoprotection in vitro" (2012).

"Confidence Interval.

The composition of Example 3 has an average UVA SPF of 23.7.

Example 8

An in vivo study was conducted in order to evaluate the Sun Protection Factor (SPF) of the composition of Example 3, applied in standardized and defined zones, on 10 healthy adult subject's back, followed by exposure to UV radiation according to the ISO/EN24444 Cosmetics Sun Protection test methods - In vivo determination of the Sun Protection Factor (SPF) (2010).

"Confidence Interval.

The composition of Example 3 has an average SPF of 90.1 .

Example 9

A test was conducted in order to evaluate the potential of cutaneous photoallergy and phototoxicity of the composition of Example 3 compared with a controller (NaCI 0.9%), for skin application in controlled and maximized conditions, during 6 weeks in 34 subjects, with 21 to 67 years old, phototype II and III (Fitzpatrick), under dermatological control.

The test was supervised by a dermatologist wherein the composition of Example 3 and the controller were applied and distributed in a patch test dully identified, which were applied on the upper back of the subjects.

The applications occurred every Mondays and Wednesdays during 3 consecutive weeks. After 24 hours of the applications, the patch test was removed by technicians and, after approximately 30 minutes of the removal, the area received UVA and UVB irradiation. After each irradiation, the area was evaluated. On Fridays, only readings were taken.

Subsequently this period (induction), there was a period of at least 10 days, when no patch test was applied to the back of the subjects (rest period).

Then, the challenge period began and the composition of Example 3 was applied another time, remaining for a period of 24 hours. After 30 minutes of the removal, the area received UVA irradiation and was immediately evaluated and after 24, 48 and 72 hours.

The subjects were evaluated by a dermatologist at the beginning and at the end of the test and also monitored throughout the test.

As a conclusion, the composition of the present invention did not induce cutaneous photoalergic or phototoxicity in the subjects. Also, the product was considered safe under the evaluated conditions.

Example 10

Tests were conducted in order to evaluate the repellent action of the composition of Example 3, according to the Operational Standard Procedure POP-M 0095 - Efficacy Test on Repellent Products for Human (2010). Such test is based on the methodology described in OPPTS 810.3700(2010) - EPA (2010).

The repellent action of the tested composition was evaluated in view of three species of mosquitos: Culex quinquefasciatus, Aedes aegypti and Anopheles aquasalis.

The tests were conducted in controlled conditions, with 5 subjects (men and women between 18 to 65 years old), that were previously approved by a established inclusion criteria.

The amount of the composition to be applied in each subject was calculated according to the size of the forearm of each individual, following the formula below:

Amount of the tested composition (g) = [{( M1 + M2 + M3 + M4)/4} x c/GOa]

C - size of the forearm (cm)

M1 - Forearm circumference at wrist height (cm)

M2 e M3 - Two measures equidistant from the circumference of the forearm between the elbow and the wrist (cm)

M4 - Circumference of the forearm at the elbow (cm)

Then, the calculated amount of the composition of Example 3 was applied, spreading it evenly and protecting the hand with a disposable glove. Each subject exposed its forearms to the mosquitos, after 30 minutes of the application of the tested composition.

The subsequent evaluations were performed every 30 minutes. The number of landings and bites, in each exposure, was registered during 5 minutes using a chronometer.

The test was ended when a bite was confirmed. A confirmed bite is defined when in a single exposure period more than one bite occurs, or when a bite occurs in two consecutive exposures.

The numbers of landings were also registered at the ending of the test. The mean of the number of the repellent action time is given by the average time of action of the tested composition. The amplitude, in absolute values, was also registered.

Regarding the specie Culex quinquefasciatus, we observed an average repellent action time of 222 minutes.

Regarding the specie Aedes aegypti, we observed an average repellent action time of 132 minutes.

Finally, regarding the specie Anopheles aquasalis, we observed an average repellent action time of 84 minutes.

Therefore, it is concluded that the composition of Example 3 shows repellent action.

Example 11

An accelerate stability test was conducted in order to evaluate the stability of the composition of Example 3. The composition was evaluated under controlled temperature and time. The evaluated parameters were organoleptic characteristics, pH and appearing viscosity value, as follows:

Example 3

Evaluated T0<¹> T0<¹> 2 months at room 2 mounts at Parameters temperature 45 ^eC

Aspect Fluid cream, smooth Conform⁽²⁾ Conform Conform and homogeneous

Color White Conform Conform Conform

Odor Fragrance Conform Conform Conform pH 6.3 ± 0.3 6.5 6.5 6.5

Viscosity 636 to 1265 rnPas 835 948 957 Example 3

⁽¹⁾ TO: Control performed at least 1 6 hours and at most 72 hours after the manufacture

<²> Conform: The composition maintained the control parameters (TO).

Example 12

An in vivo study was conducted in order to evaluate the Sun Protection

Factor (SPF) of the composition of Example 5, applied in standardized and defined zones, on 1 0 healthy adult subject's back, followed by exposure to UV radiation according to the ISO/EN24444 Cosmetics Sun Protection test methods - In vivo determination of the Sun Protection Factor (SPF) (2010).

"Confidence Interval.

The composition of Example 5 has an average SPF of 40.

According to such test, it is possible to observe the technical advanced of the composition of the present invention, which achieved a highest SPF and good stability in view of the starting composition.

Claims

SET OF CLAIMS

1 . Repellent sunscreen composition comprising:

(a) a UV filter system comprising a mixture of terephthalylidene dicamphor sulfonic acid and, octocrylene and butyl methoxydibenzoylmethane;

(b) an emulsifying system comprising a mixture of emulsifying agents, glyceryl stearate (and) PEG-100 stearate, potassium cetyl phosphate and stearyl alcohol; and

(c) a repellent agent chosen from N,N-diethyl-m-toluamide (DEET).

2. Composition, according claim 1 , wherein the amount of the mixture of UV filters is from 5% and 35%, preferably between 7% to 30% and even more preferably between 10 to 29% by weight of to the total weight of the composition.

3. Composition, according to any one of the preceding claims, wherein the amount of the mixture of emulsifying agents is from 0.1 % to 5%, preferably of 0.2% to 4% and even more preferable between 0.5 to 3.5% by weight of the total weight of the composition.

4. Composition, according to any one of the preceding claims, wherein the amount of N,N-diethyl-m-toluamide (DEET) is from 2% to 10%, preferably of 3% to 7%, more preferable between 3.5 to 6%, and even more preferably between 3.5 to 5.5% by weight of the total weight of the composition.

5. Composition, according to any one of the preceding claims, wherein it further comprises cosmetically acceptable ingredients selected from additional sunscreens, perfume/fragrance, polymers, preserving agents, solvents, additional actives, surfactants, fat materials, vitamins, fillers and mixtures thereof.

6. Composition, according to any one of the preceding claims, wherein it presents a Sun Protection Factor 40.

7. Composition, according to any one of the preceding claims, wherein it presents a Sun Protection Factor 90.

8. Composition, according to any one of the preceding claims, wherein it is in the form of an O/W emulsion.

9. Use of a composition as defined in any one of the preceding claims, wherein it is for the manufacture of a product to be used as sunscreen and repellent.

10. Use, according to claim 9, wherein it is for the manufacture of a product for preventing sunburns and insect bites. WO 2019/036774 -j g PCT/BR2017/050246

1 1 . Use, according to one of claims 9 or 1 0, wherein the composition is in the form of an O/W emulsion.

12. Use, according to any one of claims 9 to 1 1 , wherein the composition is a hypoallergenic composition.

13. A method of protecting a keratinous substrate from ultraviolet radiation and/or insect bites, the method comprising contacting the keratinous substrate with the composition, as defined in claim 1 .