The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has endorsed the sun creams’ Ladival sensitive skin SPF 50+ ‘from STADA and’ ISDIN fotoprotector fusion water SPF 50+. Facial sunscreen for daily use ‘by ISDIN after presentation of complementary studies by these two companies.
The AEMPS began in December 2019 a campaign to control the market for sun protection products, to ensure that the sun protection factor (SPF) claimed on the label does not differ from that determined in the tests.
After the analysis, nine of the tested plots did not have an SPF consistent with that indicated on their labeling, but they obtained an SPF between 30 and 50, considered an SPF within the high protection range.
For this reason, the AEMPS urged these nine companies to voluntarily withdraw only the batches tested and requested additional information, as well as, if necessary, to carry out additional trials on other batches, to verify the safety of the products.
Now ISDIN and Ladival (STADA) They have presented new information that supports their use. Specifically, on ‘ISDIN Photoprotector Fusion Water SPF 50’, in the test carried out by the AEMPS of this batch, an average value of SPF very close to 50 has been obtained, specifically a value of 46.3 (standard deviation of 6.4 ). According to company information, this lot was distributed in 2020, so it is estimated that there are currently no units available on the market.
The company has submitted nine studies carried out on its product which, based on the evaluation carried out by the AEMPS, would endorse an SPF of 50. This is why the AEMPS considers that “it is not necessary to withdraw other batches of the product and that, therefore so much, it can continue to be marketed in Spain “.
For its part, regarding ‘Ladival sensitive skin SPF 50+’ by STADA Arzneimittel AE ‘, in the tests carried out by the AEMPS of this batch, an average value of SPF very close to 50 has been obtained, specifically a value of 46.6 ( standard deviation of 7.8) and 43.9 (standard deviation of 8.7). According to company information, this lot has not been released for sale.
The company has submitted two SPF studies carried out on its product which, taking into account the evaluation carried out by the Agency, would endorse an SPF of 50. This is why it can continue to be marketed in Spain.
The AEMPS clarifies, however, that “as of today, in any case, no incidents of sunburn related to either of these two products have been reported to the Spanish Cosmetovigilance System “.
Health explains that “variability” is observed in the methodological application of the technical standard ‘ISO 24444 Sun protection test methods. In vivo determination of SPF ‘, which affects high SPFs (50 and 50+). “This variability hinders the desirable reproducibility to accurately measure the most relevant parameter of the effectiveness of sunscreens, which is the SPF”, details the AEMPS.
In view of the results of the campaign, the AEMPS advances that “it will insist on the working groups of the European institutions and, internationally, on the ISO / TC 217 Cosmetics Committee, responsible for the development of the ISO 24444 standard, in the need for a robust measurement method to determine the SPF, that generates confidence to the citizenship, to the industry of the solar products and to the authorities in the decision making “.
Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.