Sunscreen sun protection factor claim based on in vivo interlaboratory variability.

OBJECTIVE: The SPF (sun protection factor) is the best known reference in the world for expressing UVB protection. The SPF is used for labelling purposes for consumer guidance. The determination of the SPF is often accomplished using an in vivo method that has been standardized. Only one in vivo SPF value from one laboratory is required for claiming an SPF value. The aim of this study was to determine the relevance of the in vivo SPF value in terms of interlaboratory variability for claiming purposes and to determine whether some minimum number of different in vivo SPF values from different laboratories would improve the reliability of the final SPF claimed. METHODS: A large population of 44 different commercially available sunscreen formulations from the European market has been investigated, covering various product types. The majority of the SPF values claimed ranged from 15 to 50+. For each product, at least three different in vivo SPF values tested in different laboratories have been gathered, and a variety of statistical analyses have been performed. RESULTS: For each SPF category from the average of all samples, the minimum and maximum in vivo-measured SPF values from the different laboratories would lead to labels claiming different levels of SPF for the same product. Indeed, with coefficients of variation for in vivo SPF determinations that exceed 50% in some cases, as an example, the same product could in reality be claimed to be SPF 30, SPF 50 or SPF 50+. CONCLUSION: In this study, the authors demonstrated that using only one in vivo SPF value from one laboratory may actually challenge the reliability of the final SPF claim significantly. To reduce the consumer health risk by ensuring the reliability of the SPF claim, an average from at least 3 (ideally 4) different in vivo SPF values should be compulsory.

New approach for a reliable in vitro sun protection factor method - Part II: Practical aspects and implementations.

OBJECTIVE: Our previous paper (Part I: Principle and mathematical aspects) presented a new reliable in vitro sun protection factor (SPF) method and demonstrated it to be reproducible and correlated with the in vivo method. Nevertheless, the relevance of an international method should to be adaptable to all products on the market and demonstrated with a blind test. Thus, the aim of this second article was to focus on the practical aspects and implementation (Part II) of a large population of different commercially available sunscreen formulations to obtain similar in vivo SPF results for the purpose of labelling. METHODS: The method uses the spectroradiometric measurement of residual ultraviolet (UV) through the sample that was applied on a substrate with a robotic appliance. The method has been demonstrated to be highly reliable, and it is based on a multisubstrate solution with a single UV pre-irradiation dose. Furthermore, different categories of the product were studied to identify a reliable and universal in vitro SPF method. RESULTS: Based on different sunscreens products classified into 5 different groups (emulsion, oil, alcohol, stick and powder), it was demonstrated that our method has good reproducibility and accuracy compared with the clinical SPF method. Indeed, the mean coefficient of variation (CV%) was approximately 7%, and the coefficient of correlation reached approximately 0.8-1.0 for different types of tested products. CONCLUSION: Our second paper concludes that the new in vitro SPF method (based on 113 sunscreen products from the Parts I and II) is clearly adaptable for the SPF labelling purpose on any product type because it is non-invasive, less expensive, more practical and more reliable if performed under strict conditions.