The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has updated alert by which requested the voluntary withdrawal of 14 sunscreens why the sun protection factor (SPF) does not correspond to the labeling. Two of the affected brands have responded to the regulatory body by providing information about their products that have allowed them to be withdrawn from the alert and authorize them to continue being marketed in Spain.
The two products that have justified their sun protection results against Aemps in the last week and that are confirmed as safe are the following:
1) ISDIN Fotoprotector Fusion Water SPF 50. Fotoprotector facial de uso diario de ISDIN S.A., lote 93041F. “In the test carried out by the AEMPS of this lot, an average value of SPF very close to 50 has been obtained, specifically a value of 46.3 (standard deviation ± 6.4). According to the information of the company, 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 that, based on the evaluation carried out by the Agency, 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, Isdin Photoprotector Fusion Water SPF 50 facial photoprotector for daily use can continue to be marketed in Spain “.
2) Ladival sensitive skin SPF 50+ from STADA Arzneimittel AG, lot 93845. “In the tests carried out by the AEMPS of this lot, a mean value of SPF very close to 50 has been obtained, specifically a value of 46.6 (standard deviation ± 7.8) and 43.9 (standard deviation ± 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. That is why Ladival sensitive skin SPF 50+ from STADA Arzneimittel AG can continue to be marketed in Spain “.
12 brands remain engaged
The withdrawal request came after finalize the campaign to control the market for sun protection products, which began in December 2019 and that it was aimed at guaranteeing that the sun protection factor (SPF) claimed on the labeling does not differ from that determined in the tests.
The initiative has focused on sunscreens with SPF 50 or SPF 50+ with novel galenic forms such as very light creams, mists and sprays. In order for the sample to be representative, 19 products from companies of different sizes and origins (Spanish, European and non-EU) and products of different price ranges.
After having received the final reports of the in vitro and in vivo tests, the AEMPS has carried out a joint evaluation of these results and of the documentation required from the companies. As a result of the results, the AEMPS has initiated different actions depending on the difference between the results obtained in the tests and the claim on their labeling.
Specifically, five of the plots tested have SPF results consistent with the degree of protection of their labels, although nine products did not have a concordant SPF, although SPF values between 30 and 49.9 have been obtained, considered an SPF within the range of effectiveness of the high protection category.
However, the AEMPS has ensured that no incidents of sunburn related to any of these products have been reported to the Spanish Cosmetovigilance System. Yes OK, has urged the companies to voluntarily withdraw the batches tested and has asked them to carry out additional tests in other batches to verify the safety of the products.
The same action has been required for products in which an SPF value of less than 60 has been obtained and 50+ was claimed, which is the very high protection category. The products that are still affected are: ‘Cosmetics sun ultimate sensitive SPF 50+ spray solar sensitive skin‘, from Carrefour Shopping Centers; ‘Belle&Sun bruma solar invisible FPS 50‘by Perseida Belleza; Y ‘Farline sun spray SPF 50+ 200 mL Very high protection‘, from Farline Comercializadora de Productos Farmacéuticos SA
They complete this list ‘Babaria solar bruma protectora SPF 50‘by Berioska; ‘Seesee spray solar transparente SPF 50+‘, by Cosmetrade; ‘Piz Buin hydro infusion gel sun cream SFP 50 High protection‘, from Johnson & Johnson Health Beauty; y ‘Lancaster sun sensitive luminous tan crema confort SPF 50+‘by Coty.
The remaining five products have obtained a lower FPS than indicated on its labels, always below 29.9. In these cases, the AEMPS has urged companies to voluntarily withdraw them, which are: ‘Abelay Sunscreen SPF50’, by Ab7 cosmetics; ‘Mussvital fotoprotector spray aerosol ultra light 50+‘by Peroxfarma; ‘Eucerin sun protection sensitive protect sun spray transparent dry touch SPF 50 alta‘, de Beiersdorf AG; ‘Hawaiian Tropic Silk Hydratation Bruma Solar air soft SPF 50+ (Alta)‘by Wilkinson Sword; Y ‘Australian gold SPF Botanical SPF 50 continuous spray‘, de Biorius
Follow the topics that interest you