Used to protect the skin from UV rays, sunscreen products are fundamental to prevent the damage caused by exposure to both natural and artificial ultraviolet light. These products can be found in different formats: creams, emulsions, oils, gels, sticks or sprays. They are intended for contact with human skin and subject to strict controls to prevent photoageing and the onset of skin problems.
Sunscreen products are made up of a large number of formulation substances. Among them:
Sunscreen products are classified differently depending on the country: for example, they are considered as cosmetic products in Europe and as over-the-counter products (OTC) in the USA, Japan, Australia, and Canada. Therefore, the standards and reference methods to test sunscreen products and the information on the labelling are different depending on the reference market. The attention to the in-vitro and in-vivo analyses of sunscreen products is increasingly important and goes alongside with the research on the effect of sun exposure on our skin in the field of dermatology.
While the definition of the degree of sun protection against UVB rays remains important, the tests on UVA (in particular the UVA/UVB ratio), UVC, HEV and NIR (near infrared) rays are becoming increasingly crucial as regards the final product’s safety:
NIR non visible component, in particular NIR A, with wavelengths between 800 and 1000 nm with high dermal penetration, causes cell damage to both keratinocytes and fibroblasts. To support this innovative claim the test strategy is in vitro and includes physical, spectrophotometric and biological tests.
The test to determine SPF is certainly the main test for any cosmetic products containing sunscreen. Considering all the variables while calculating the sun protection factor is however as important. A preliminary in-vitro SPF analysis is indispensable to identify any overestimates of in-vivo SPF due, for example, to the presence of ingredients with soothing action in the cosmetic formulation.
Further tests are necessary to check that your sunscreen product is resistant to salt water, chlorinated water, sweat, and sand, ecocompatible, biocompatible and reef-safe.
Thanks to advanced technologies, cosmetic formulations can help us regulate skin pigmentation. For a more tanned skin or to reduce unsightly dark spots, cosmetic products have to act on the melanogenesis process: melanocytes synthesising and accumulating melanin. Melanins are the pigments responsible for the colour of our skin. Their synthesis depends on both sunlight exposure and genetic and/or pathological factors.
To check that they are effective, these products must be tested in vitro and in vivo. These specific tests focus mainly on the quantification of melanin before and after product use or on the increased or decreased expression of tyrosinase, an enzyme involved in the melanogenesis process.
With Abich – Lifeanalytics, you can have a full range of tests to assess the efficacy of your tanning and anti-dark spot cosmetic products in compliance with the Guidelines to Commission Regulation (EU) No. 655/2013 and testing protocols tailored on your needs.
Abich – Lifeanalytics, the Group’s Competence Center for Pharma and Cosmetics industries, offers a wide range of tests for your sunscreen products, allowing you to launch them in the main international markets and to check any aspect of their efficacy and safety.
Find out the full range of tests:
The test is designed to be applied to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “SPF Sun Protection Factor” according to proprietary method based on ISO 24443.
Preliminary screening of the sun protection factor, UVA/SPF ratio and critical wavelength of a sunscreen formula.
The test is designed to be applied to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “SPF Sun Protection Factor” according to proprietary method based on ISO 24444:2022, FDA 21 CFR 201.327 (a)(1) and Australian AS/NZS 2604:2012 protocol.
Determination of the sun protection factor (SPF) on healthy volunteer through controlled irradiation and measurement of the erythemal response.
The test is designed to be applied to finished sunscreen products with the purpose of substantiating the claim “Salt water resistant” according to ISO 24444:20122 for the determination of the water resistance.
Test performed on 10 volunteers, by comparison of pre-wash and post-wash SPF. The treatment includes two washes, one in salt water, performed by irroration with 1M NaCl solution by a pressureless drop shower, and one in fresh water. If the reduction of protection is greater than 50% the product isn’t considered to be “Salt Water Resistant”.
The test is designed to be applied to finished sunscreen products with the purpose of substantiating the claim “Sand resistant” according to ISO 24444:2010 of 15/11/2010 and Colipa test method 2006 for SPF.
In vivo test on 10 subjects. Comparison between SPF of sun product and the reduction on protection cause of double sand static contact of 20 minutes in this sequence: contact, techanical cleaning, contact and final mechanical cleaning before the exposure to the solar multiport simulator. If the reduction of protection is mayor than 50% the product isn’t “sand resistant”.
The test is designed to be applied to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “Broad spectrum protection” according to ISO 24443:2012.
Determination of the UVA protection and critical wavelength according to the ISO guideline for broad spectrum protection testing.
The test is designed to be applied to sunscreen creams, sticks and cosmetic products with the purpose of substantiating claims “UVA protection” and “PA rating” according to ISO 24442.
Method that is based on the persistent darkening responses of the skin pigmentation of the subjects in order to evaluate the UVA sun protection factor (UVAPF) of the sun product.
The test in vitro is designed to be applied to sunscreen products with the purpose of substantiating the claim “Protects against the high energy visible (HEV) spectrum” or “Blue light protection” according to proprietary method based on ISO 24443.
Analysis of the absorbance spectrum of a sunscreen product in the HEV spectrum versus blank. Results in terms of absorbance curve and percentage of light blocked in the 400-500 nm spectrum.
The test is designed to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “Water resistant” according to proprietary method based on ISO 24443.
Determination of the percentage of water resistance of a sunscreen product on PMMA plates with measurements before and after washes in controlled conditions. The preliminary test requires confirmation through in vivo tests.
The test is designed to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “Water resistant” or “Very water resistant” according to ISO 1627/2020/18861.
Determination of the percentage of persistence of the Sun Protection Factor (SPF) on healthy volunteers after washing in controlled conditions.
The test is designed to sunscreen creams, sticks and cosmetic products with the purpose of substantiating the claim “Control of the aggregational state of physical filters” according to proprietary method.
Microscopical analysis and high resolution imaging of the aggregation of physical filters. Includes measurement of the size of aggregates, if present.
The test in vitro is designed to active ingredients or finished products with the purpose of substantiating claims “Skin whitening” and “Depigmenting action” according to proprietary method.
Quantification of the inhibition of melanin synthesis in human melanoma cells exposed to the substance or product to be tested, in comparison with untreated controls. The same test can also be used to quantify an increase of melanin synthesis.
The test is designed to visage and body cosmetic products with the purpose of substantiating claims “Reduces skin blemishes”, “Skin whitening” and “Depigmenting action” according to Guidelines to Commission Regulation (EU) No 655/2013.
Instrumental measurements performed using a Minolta CR200 colorimeter will be performed at T=0 and T=X days (to be defined by previous agreement with the sponsor) in order to evaluate changes in the pigmentation of the treated area. The measurements will be performed at each time point in the same area. Acquisition of high definition images will be performed at T=0 and T=X days using a macro objective with color normalization and coaxial circular flash.
The test is designed to visage and body cosmetic products with the purpose of substantiating the claim “Tanner” according to Guidelines to Commission Regulation (EU) No 655/2013.
A first set of baseline measurements will be performed using a Minolta CR200 Colorimeter in order to identify the phototype of the target skin region and its correlated MEDu. The measurement will be repeated at T=0 and T=X days in order to evaluate changes in skin pigmentation.
All measurements will be taken in the same target region. After the treatment, treated and untreated areas will be exposed to 3 irradiation cycles across 5 days using a tanning lamp, in order to quantify the increase in pigmentation. Measurements will be performed using a Colorimeter.
High resolution imaging will be performed using a macro objective with coaxial circular flash, after each cycle of simulated sunlight exposure.
The test in vitro is designed to active ingredients, mixtures or finished products with the purpose of substantiating the claim “Depigmenting action” according to proprietary method.
Evaluation of the efficacy of a sample in inhibiting the activity of the tyrosinase enzyme in a controlled in vitro direct reaction.
The test in vitro is designed to active ingredients or finished products with the purpose of substantiating claims “Skin whitening” and “Depigmenting action” according to proprietary method.
Evaluation of the changes in the expression of the tyrosinase gene in human melanoma cells.
The test in vitro is designed to active ingredients or finished products with the purpose of substantiating the claim “Tanner” according to proprietary method.
Quantification of the increase of melanin synthesis in human melanoma cells treated with the sample substance or product in comparison with untreated controls. The same test can be used to quantify a reduction in melanin synthesis.
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