Health requests the withdrawal of 14 sun creams because the protection factor does not correspond to the labeling

The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has requested the voluntary withdrawal of 14 sunscreens because the sun protection factor (SPF) does not correspond to the labeling.

This request comes after the end of the market control campaign for sunscreen products, which began in December 2019 and was aimed at ensuring 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 were chosen.

After receiving the final reports of the in vitro and in vivo tests, the AEMPS has carried out a joint evaluation of these results and 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 consistent SPF, although SPF values ​​between 30 and 49.9 have been obtained, considered an SPF within of the efficacy range 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 Cosmethovigilance System. However, it has urged the companies to voluntarily withdraw the batches tested if they are still on the market and has asked them to carry out additional trials on 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. These latest products are: 'Les Cosmetiques sun ultimate sensitive SPF 50+ sun spray for sensitive skin', by Carrefour Shopping Centers; 'Belle & Sun invisible solar mist SPF 50', by Perseida Belleza; 'Isdin photoprotector fusion water SPF 50+. Facial sunscreen for daily use ', by ISDIN; and 'Farline solar spray SPF 50+ 200 mL Very high protection', by Farline Comercializadora de Productos Farmacéuticos SA

This list is completed by 'Babaria solar protective mist SPF 50', by Berioska; 'Seesee transparent sun spray SPF 50+', by Cosmetrade; 'Piz Buin hydro infusion gel sun cream SFP 50 High protection', by Johnson & Johnson Santé Beauté; 'Ladival sensitive skin SPF 50+', by STADA Arzneimittel AG; and 'Lancaster sun sensitive luminous tan comfort cream SPF 50+', by Coty.

The remaining five products have obtained an SPF lower than that indicated on their labels, always below 29.9. In these cases, the AEMPS has urged companies to voluntarily withdraw them, which are: 'Abelay Sunscreen SPF50', from Ab7 cosmetics; 'Mussvital fotoprotector spray aerosol ultra light 50+', by Peroxfarma; 'Eucerin sun protection sensitive protect sun spray transparent dry touch SPF 50 high', by Beiersdorf AG; 'Hawaiian Tropic Silk Hydratation Solar Mist air soft SPF 50+ (High)', by Wilkinson Sword; and 'Australian gold SPF Botanical SPF 50 continuous spray', by Biorius.


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