SPF Testing and Clinical Sunscreen Testing Studies
Testing the Sun Protection Factor (SPF) of cosmetic products is crucial to ensure they provide the claimed level of UV protection. There are two primary methods for SPF testing: in vivo and in vitro.
SPF Testing and Clinical Sunscreen Testing Studies
Testing the Sun Protection Factor (SPF) of cosmetic products is crucial to ensure they provide the claimed level of UV protection. There are two primary methods for SPF testing: in vivo and in vitro. In vivo testing is conducted on human volunteers. The product is applied to the skin, which is then exposed to UV light to determine the minimum erythema dose (MED)—the smallest dose that causes redness. The SPF is calculated by comparing the MED of protected skin (with sunscreen) to unprotected skin. In vitro testing, on the other hand, is a laboratory-based method that uses a substrate, such as a PMMA plate. The product is applied to the substrate, exposed to UV radiation, and the amount of UV light that passes through is measured. This transmittance data is then used to estimate the SPF value.
Regulatory considerations are essential for both methods. Testing must follow international guidelines, such as ISO 24444:2019 for in-vivo and ISO 24443:2012 for in vitro testing. Additionally, compliance with regulatory authorities’ requirements, like the FDA in the USA and the European Commission in the EU, is necessary for accurate labeling and marketing of the product. While in vivo testing is considered more accurate, in vitro testing serves as a useful preliminary or supplementary method. Both methods aim to ensure that cosmetic products provide effective sun protection, safeguarding consumers against harmful UV radiation.
Frequently asked questions about SPF Testing and Clinical Sunscreen Testing Studies
Typically, what service elements might this involve?
Evaluating a cosmetic product for SPF testing and clinical sunscreen testing typically involves several key service elements. These include in vitro SPF testing using standardised methods to measure UV protection, in vivo testing on human subjects to confirm efficacy and safety, water resistance testing, and photo stability assessment to ensure the product maintains its effectiveness under UV exposure. Additional services might include detailed dermatological assessments, adherence to regulatory guidelines, formulation analysis, and comprehensive reporting of results. Clinical studies may also involve testing for potential skin irritation or sensitisation to ensure overall product safety and consumer satisfaction.
AS/NZS 2604:2021 (SPF 0 – 45)
AS/NZS 2604:2021 (SPF 45+)
FDA Static UV test (SPF 0 – 45)
FDA Static UV test (SPF 0 – 45) + Water Resistance FDA
FDA Static UV test (SPF 45+)
FDA Static UV test (SPF 45+) + Water Resistance FDA
ISO 24442 UVA PF In-Vivo (SPF 0 – 45)
ISO 24442 UVA PF In-Vivo (SPF 45+)
ISO 24443 UVA PF + CW (In-Vitro)
Blue Light Testing (In-Vitro)
ISO 24444 (SPF 0 – 45)
ISO 24444 (SPF 0 – 45) + Water Resistance ISO 16217:2020
ISO 24444 (SPF 0 – 45) + Water Resistance ISO 18861:2020 (40 / 80 mins)
ISO 24444 (SPF 45+)
ISO 24444 (SPF 45+) + Water Resistance ISO 16217:2020
ISO 24444 (SPF 45+) + Water Resistance ISO 18861:2020 (40 / 80 mins)
Sweat Resistance (addition to ISO 24444 / FDA Static / AS/NZS 2604)
Sand Resistance (addition to ISO 24444 / FDA Static / AS/NZS 2604)
What other services does my product require?
Talk to our team of experts and we will be able to advise on all aspects of your products requirements. We take time to understand you claims and product attributes and create a recommendation of the exact services we can provide to get your product to market. Explore our recommended services below, try our product checkup or book a free consultation with our team.
How long does it take?
This varies depending on the product, but we aim to work closely within your timeframe and constraints. Our customer service offer is designed to make your life as easy as possible with a dedicated point of contact in most cases and a detailed schedule to keep you up-to-date with the process.
Why use ADSL?
Formed in 2008, our fully qualified, independent team of Chartered Chemists, Toxicologists, Microbiologists and Regulatory experts specialise in formulation and testing services within the cosmetic, household goods, food and industrial sectors. We are a UKAS accredited testing laboratory offering a range of accredited and non accredited microbiological tests. Our team includes individuals with a host of industry qualifications including Fellows of the Royal Society Of Chemistry and a “Chartered” Chemist and Scientist, Members of The Society Of Cosmetic Scientists, Members of the British Toxicology Society, Members of Society of Dermatology, Members of International Society of Dermoscopy, Members of European Academy of Dermatology & Venereology (EADV) along with Chem CSci, CChem FRSC and PhD attainment. With our exceptional expertise and complementary skills in manufacturing, process controls, industry regulation, health and safety, marketing, and project management we are with you every step of the way to see your product through to successful market launch. Furthermore, our technical consulting helps many businesses by cost effectively filling gaps in their skills and knowledge base and providing a fresh perspective and strategy on the best way forward. Fundamentally we have the the knowledge and know-how to successfully take your cosmetic product to market. Your product inside out.
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Experts in our field, we have over 20 years of cosmetic formulation, compliance, testing and safety experience. Through this experience we can help customers to navigate through the increasingly demanding regulatory landscape.
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