The Spanish Medicines Agency (Agencia Española del Medicamento) responds to the OCU's accusations that the effectiveness of seven brands of sunscreen products was questioned. At the beginning of June, the OCU published a report accusing seven brands that the effectiveness of these sunscreen products was not as advertised on their labels. As a precautionary measure, the first action taken by the AEMPS was to order the cessation of marketing and withdrawal from the market after having informed the companies of this decision.
The AEMPS ordered the companies involved to produce a report to clarify the discrepancies between the results of the SPF and UVA FP tests to compare with the results published by the OCU. The agency itself points out that in recent years, a certain flexibility has been observed in the application of the technical standard UNE EN ISO 24444, which hinders the desirable reproducibility to measure the SPF of sunscreens in an exhaustive and more precise manner. The AEMPS has been responsible for pointing this out in official forums at European and international level, stressing that it is necessary to strengthen the method in order to achieve a more accurate measurement method.
The AEMPS received studies from three companies demonstrating that their products comply with the SPF and/or PF-UVA claimed in the labelling. With these new results, the AEMPS has modified some of its initial decisions:
- VICHY Capital Soleil Crème Onctuese Protectrice SPF 50+. The AEMPS has decided that with the data provided by the company Cosmetique Active International it can continue to be marketed, except for a certain batch where it maintains the cessation of marketing as the company admits that it has not been able to carry out the study on this batch due to the lack of available units.
- BIOTHERM Waterlover Face Sunscreen SPF 50+. The company Prestige & Collections International has provided new studies carried out on the product, but not on the batch that had been withdrawn, because, like the previous company, it did not have the necessary quantity of product to carry out these tests. The AEMPS has decided that it can also continue to be marketed.
- ISDIN Fusion Water Magic SPF 50. In this case, the AEMPS did not take any action in this respect as it considered the indicators in the OCU report to be deficient. Now, with the data provided by the company, the Medicines Agency reinforces its decision and sees no problem in continuing to market it.
Regarding the products of other brands such as Rituals, the company has informed that additional testing of the products is still ongoing and for the other brands, the AEMPS has not yet received any additional data from the other companies involved.