Order date	February 26, 2025
Research time frame	February 13, 2025 – March 14, 2025
Report number	B-0055/25
Date of issue of the report	15.04.2025

Responsible company name
Company name	Nexus Cosmetics
Address	Industrial Park 33 Zone A, 2220 Heist-op-den-Berg, Belgium

Product name	Sun Mist SPF 50 48-000-0994.08
Ingredients	Dicaprylyl carbonate, dibutyl adipate, alcohol denat., diethylaminohydroxybenzoylhexyl benzoate, propyl heptyl caprylate, undecane, ethylhexyl salicylate, bis-ethylhexyloxyhenol, methoxyphenyltriazine, diisopropyl adipate, ethylhexyltriazone, tridecane, diethylhexylbutamidotriazone, maleated soybean oil, glyceryl/octyldodecanol esters, phenethyl benzoate, perfume, Crambe Abyssinica seed oil, ethyl cellulose, isopropyl alcohol, bisabolol, tocopherol, glycerin, Helianthus annuus seed oil, aqua, xanthophylls, Rosmarinus officinalis leaf extract
Expected SPF	50

Certificate of Spectral Measurement - SUMMARY
Characterization of the UV source with intensity in units of energy/unit area
	MULTIPORT (MP) SOLAR SIMULATOR
Solar simulator SN:	24303 (October 29, 2024)
	Gate 1	Gate 2	Gate 3	Gate 4	Gate 5	Gate 6
% RCEE <290 nm (<0.1%)	0.029%	0.005%	0.045%	0.002%	0.007%	0.001%	Passed
290 nm-300 nm (1.0%-8.0%)	3.3%	3.4%	3.6%	3.4%	3.4%	3.4%	Passed
290 nm-310 nm (49.0%-65.0%)	52.5%	53.1%	53.7%	53.0%	52.7%	53.0%	Passed
290 nm-320 nm (85.0%-90.0%)	85.7%	86.1%	86.4%	86.1%	85.8%	86.1%	Passed
290 nm-330 nm (91.5%-95.5%)	92.3%	92.6%	92.7%	92.6%	92.3%	92.7%	Passed
290 nm-340 nm (94.0%-97.0%)	95.0%	95.1%	95.2%	95.1%	94.9%	95.3%	Passed
290 nm-400 nm (99.9%-100.0%)	100.0%	100.00%	100.00%	100.00%	100.00%	100.00%	Passed
% UVA2/Total UV (>20%) 320-340 nm / 290-400 nm)	26.4	26.7	26.6	26.6	26.2	26.2	Passed
% UVA1/Total UV (>60%) (340-400 nm / 290-400 nm) Uniformity >90%	63.8	63.2	63.3	63.4	64.0	64.0	Passed
	90.33	98.47	98.34	93.94	95.81	96.62	Passed

Reference sunscreen formulation	Average SPF	Acceptance limits
		Lower limit	Upper limit
P2	16.1	13.7	18.5
P3	15.7	13.7	17.7
P5	30.6	23.7	37.4
P6	43.0	31.0	54.9
P8	63.1	43.9	82.3

Procedure :
1. Skin acclimatization period - test conditions should be stable with room temperature maintained between (23±3) oC
2. ITAo determination on the back of the subject;
3. Demarcation of test locations on the subject's back
The test sites intended for UV exposure must be free of stains and hair, and have an even color tone with no variation in ITA° greater than 5° from each other or the MEDu test area. If necessary, the hair should be shaved more than three days before the test, but not afterward. If necessary, the hair may be clipped or trimmed with scissors on the day of the test.
- the minimum total area for a product application test location must be 30 cm2 and the
maximum should be 60 cm2
The positions of the test products and reference test sites for sunscreen should be randomly distributed across the backs of test subjects across the entire test group to reduce errors due to anatomical differences in the skin. The unprotected test site used to determine MEDu is randomly selected as one of the test sites within the test area and across all test subjects.
- there must be a minimum distance of 1 cm between the edges of adjacent test sites.
- Before applying the product, the test area may be cleaned with a dry cotton pad or a
equivalent.
- The test sites are demarcated using a method that does not interfere with the test or harm the subject, such as a skin marker and/or a stencil made of non-absorbent material. The skin marker must be indelible so that it is recognizable during MED evaluations 16 to 24 hours after UV exposure.
4. Weighing the product at the test site.
- the amount of test product and reference sunscreen applied to the skin after spreading should be (2.00 ± 0.05) mg/cm2.

- the scales used to weigh the products must be accurate to 0.1 mg to be able to weigh accurately.
- All products must be homogeneous and must be shaken before weighing to ensure even distribution.
- when handling the product during weighing or before applying to the skin
Take appropriate measures to prevent evaporation of volatile components. It is important that the total amount of weighed product is transferred to the application site. The amount of product to be applied should be weighed into a syringe or another device, such as a watch glass. A method for weighing by loss is required.

5. Applying the product to the test site
- The use of a finger cot (e.g., latex, nitrile, etc.) is required, except in cases where using a finger cot would hinder even application of the product. Use a new finger cot for each new application of the product and do not allow it to become saturated with the test product beforehand. When using a bare finger, a maximum of 2.1 mg/cm² (5% extra) may be applied to the test area to account for the additional surface area of ​​the application finger. The finger should be cleaned with an alcohol wipe between applications.
There are 3 application techniques depending on the product type:

• Method A: Liquid products (lotion, cream, oil, liquid, gel, pump spray, roll-on, aerosol spray)
  /first degassed/.
  To promote even coverage, droplets (at least 15 per 30 cm2, 30 per 60 cm2) of product should be applied to the test site at one time using a syringe/pipette and then spread over the entire test site, first using circular motions to collect the droplets and then in horizontal and vertical directions with light pressure. It is recommended that The application finger must remain in contact with the skin throughout the entire process. Spray products supplied in a pressure canister must first be degassed by puncturing a very small hole in the canister to release all pressure. Degassing must be carried out under appropriate safety precautions by securing the canister in a ventilated safety hood with appropriate personnel safety equipment. The degassed canister must be left at room temperature for 24 hours, after which the product must be transferred to a separate, closed container with minimal headspace to minimize evaporation.
• Method B: Non-flowing viscous liquids and semi-solids (stick, balm, roller).
  The test product should be measured in a scale and applied with your finger to various spots on the test area, first using circular motions to collect the material, then applying light pressure horizontally and vertically. It is recommended to keep the application finger in contact with the skin throughout the entire process.
  
• Method C: Powders. Powder portions should be applied to the skin in a grid using a spatula, sponge, or finger. The collected powder should be tapped and then spread over the entire test site using a finger, with or without a finger cot. Alternatively, the tip of a pre-filled cosmetic applicator can be used instead of a finger. In this case, it is important to check whether (2.00 ± 0.05) mg/cm² of test powder remains on the skin after spreading by weighing the powder remaining on the applicator tip.
  Purified water or another suitable solvent without UV protection can be applied to the skin before applying the powder to promote adhesion of the sample to the application site. Water or solvent should not turn the powder into a paste and thus affect the SPF value.
• Method D: Foam formulations. For samples presented as foam, the contents of which cannot be extracted or dispensed other than as foam, the test product should be measured into a weighing boat and the sample should then be degassed or deaerated until it can be easily applied to the skin. Application should then be performed according to Method B.
• The dispersion time should be between 35 and 15 seconds, depending on the surface and the ease with which the product spreads. Volatile liquids should be dispersed immediately.
• After application is complete and before starting UV exposure, the application should be checked with an ultraviolet-A "Woods" lamp with a minimum power of 6 W. This lamp can visualize the uniformity of the application. If noticeable irregularities or streaks are observed in the product, the test site is rejected and should not be used for testing. If another test site is available, a new application can be attempted.

6. Waiting time (15 to 30 minutes) before exposing the test site to UV light; any external
Exposure of the test sites to UV light (artificial or natural) should be avoided during this period and for a period of 24 hours following exposure.

7. UV exposure:
- the minimum area of ​​each exposure subsite must be 0.5 cm2,
- the minimum distance between the edges of each exposure subsite (spots) must be at least 0.8 cm,
- the distance between each exposure subsite and each edge of the test site should be at least 1 cm,
- the minimum number of exposure subsites used must be five for unprotected MED
(MEDu) and five for protected MED (MEDp)

8. MED assessment
- Preliminary MEDiu - before the main test starts, it may be necessary to
To determine a preliminary MEDiu to center the UV dose ranges for MEDiu and MEDip exposures. A preliminary MEDiu is a preliminary test in which a subject's MEDiu must be determined.
determined before the test MEDiu is determined. This is done by
Apply a preliminary series of UV exposures up to one week before the test. The preliminary MEDiu is determined using the colorimetric ITA° technique using the UV dose range in
Table 2.
- Estimated MEDiu - if the provisional MEDiu has not been determined before the product test day
, the MEDiu can be estimated using a colorimetric technique (ITA°) without UV-
exposure on the same day as the test. The estimated MEDiu exposure dose is
determined using the colorimetric ITA° technique and the UV dose range from Table 2.
Otherwise, use the provisional MEDiu previously determined above.
- For each subject, the unprotected MEDiu is determined on the same day as the
test product protected MEDip.

For the unprotected location, the range of UV doses applied is determined based on the
preliminary MEDiu of the subject, or the estimated MEDiu based on the ITA°. At least five
sub-locations, centered at or near the preliminary/estimated MEDiu, are exposed with
incremental UV doses with a recommended geometric progression of 1.25×. Other
Geometric progressions less than 1.25× can be used (such as 1.2; 1.15; 1.12), but must be consistent throughout the test (the same progression is used for unprotected and protected
Exposure times can be rounded to the nearest integer (seconds).

- For the locations protected by the product, the administered UV doses are defined by the expected
MEDip, which is a multiple of the expected SPF of the test product (as determined by
The expected MEDiu (the test sponsor or previous data) and the preliminary or estimated MEDiu for the subject should be exposed. At least five subsites centered on or near the expected MEDip should be exposed with incremental UV doses using a recommended geometric progression of 1.25×. Other geometric progressions may be used (such as 1.2, 1.15, or 1.12). A maximum geometric progression of 1.15 should be used for an expected SPF ≥25. Smaller geometric progressions (such as 1.12) may be used but should also be consistent throughout the exposure procedure (the same progression used for both unprotected and protected sites).
- The expected value of the SPF may change during product testing
between subjects are changed at the request of the test sponsor or laboratory management
to prevent test failures or overexposure of subjects.
- The minimum erythematous dose for individual unprotected skin (MEDiu), for the test product individual protected skin (MEDip), and the MEDip for the reference sunscreen formulation should all be determined on the same day.
- The MED(s) should be assessed 20 hours ± 4 hours after exposure to UV radiation (between 16 and 24 hours),
measured from the end of the last exposure period. During the time interval between
UV exposure and MED assessment requires the subject to have additional UV exposure (artificially
Avoid direct exposure to UV light or sunlight to the exposed area. Any additional UV exposure (natural or artificial) to an individual's test area will invalidate that individual's data, and that data will be discarded from the test results and will not count toward the total number of discarded subjects allowed.
- Reactions observed at the exposure sites may be pink/red (erythema), gray/brown
(pigmentation) or a mixture of both. If the exposure site has a gray/brown coloration,
the skin surface should be lightly pressed with a microscope slide to determine whether there is also
erythema is present. If erythema is present, there will be a slight pallor of the
Redness of the skin may occur due to the pressure and the color will return after the pressure is removed.
The spot is graded as unequivocal erythema provided that the recurrent
Redness in the exposed subsite is greater than that of the unexposed surrounding skin, and the erythema occurs on more than 50% of the exposed subsite. Pigmentation reactions
(without erythema) are not considered a qualifying reaction for MEDu
or MEDp
- The rating scale for UV-exposed test sub-locations is:
0: no erythema present
0.5: ambiguous erythema, and/or no clear border, and/or filling no more than 50% of the skin.
exposure subsite
1: Observable unequivocal erythema with distinct borders covering more than 50% of the
exposure subsite fogging (MED if it is the lowest exposure dose with grade 1)
2: Moderate to intense erythema

9. Calculations
- The SPFi of both the reference sunscreen and the product being tested for each subject
must be calculated as shown below and expressed to one decimal place by truncation:

Where MEDip is the MED of an individual's sunscreen-protected skin
MEDiu The MED is of an individual's unprotected skin
- The SPF result for the test product and for the reference sunscreen formulation is
calculated as the arithmetic mean of all valid individual SPFi values.
- The minimum number of valid SPFi values ​​is ten and the maximum number is
Valid SPFi values: twenty. A maximum of five results may be excluded from the calculation.
of the average SPF, but any exclusion must be justified based on the rejection criteria explained below
or if there is non-compliance with the protocol. A sixth invalid result
automatically invalidates the entire test for that test product and
no SPF can be calculated for it.
- The average SPF of the reference sunscreen formulation used in the test should fall within the acceptance limits shown in Table 1.

The aim of the study

• The aim is to confirm the expected sun protection.
  

Rejection criteria
The panelist's results will be rejected and the panelist will be replaced if:

• A person's series of UV exposures does not result in an erythematous reaction at any subsite 16 to 24 hours after exposure.
  
• The erythemal reactions within an exposure series are randomly absent 16 to 24 hours after exposure, indicating an uneven distribution of the product, inconsistent light irradiation, or an unstable product.
• All subsites in the exposure series show an erythematous response 16 to 24 hours after exposure, making MED calculation impossible.
• If any of the above criteria apply to the exposure series on unprotected skin or to the reference sunscreen exposure sites, all data for all products on that topic are invalid and will be rejected. The test is considered a technical failure, even if the MED response is observed at the protected site.
• If any of the above criteria apply to an exposure series treated with a test product, then all data for that test product on that subject are invalid and will be rejected.
• If invalid data (MEDu or MEDp) for one product have to be rejected from more than five subjects, the entire test for that product is invalid and will be rejected.
• If invalid data for the reference sunscreen have to be rejected from more than five subjects, the entire trial is considered invalid and should be rejected.

Selection of test subjects – volunteers
The selection of subjects – volunteers was carried out by a dermatologist in accordance with the 1964 Declaration of Helsinki (as amended), Polish laws, Cosmetics Europe guidelines, and the application of exclusion criteria as listed below:
a) children and persons under 18 years of age or >70 years of age;
b) pregnant or lactating women;
c) subjects using drugs with photosensitizing potential;
d) subjects using anti-inflammatory drugs;
e) subjects with systemic dermatological conditions (including dysplastic nevi);
f) subjects with a history of abnormal reaction to the sun;
g) subjects who have used sunbeds in the eight weeks preceding the SPF test;
h) subjects who have had sun exposure on the back within the eight weeks prior to the SPF test;
i) subjects with spots, patches or nevi in ​​the test area;
j) subjects presenting with existing sun damage in the test area;
k) subjects with excessive hair growth at the test site on the day of the test (may
shave up to 3 days before the test day);
l) subjects with skeletal prominences and extreme curvatures in the test area.

Subjects are selected based on their colorimetric ITA° value. Subjects' skin must have a colorimetric ITA° value of ≥ 28°.
· Colorimetric ITA° values ​​and skin color categories are defined by the colorimetric
descriptions by Chardon et al. [9] using the CIE (1976) L*a*b* color space.

• Subjects may participate in a test provided that at least 8 weeks have elapsed since their participation in a previous UV exposure study (i.e., SPF, UVA-PF, photoallergy, phototoxicity test
  ) and that any sun-induced skin spots from previous tests on the test sites on the back have disappeared and are no longer visible.
• Ten people participated in the study. They met the eligibility requirements and provided informed consent. The skin in the selected area was normal, without lesions. The subjects were informed not to use antihistamines or pharmacological agents during the test, as these could affect the test results.

Table 4. Characteristics of the subjects.

Results
In 10 subjects, the SPF of the product Sun Mist SPF 50 48-000-0994.08 averaged 54.3. The SPF in the Cosmetics Europe P3 control sample averaged 16.4. The SPF in the Cosmetics Europe P8 control sample averaged 60.3. (See Appendix 1)

CONCLUSION

• The study was conducted in accordance with the recommendations of Cosmetics Europe and in accordance with the international standard ISO 24444:2019 on sun protection factor (SPF).
• The tested material Sun Mist SPF 50 48-000-0994.08 delivered an average SPF value of 54.3 when tested on ten test subjects as described herein under static conditions.

Stamp and signature of researcher

1. This report may only be reproduced in its entirety. Any other form of copying requires the written permission of the contractor. 2. The research report is available in two identical copies (copy 1 – client, copy 2 – diagnostic test). 3. The results apply exclusively to the product of the composition provided by the client.

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