Health ministry stops sale of six sun creams distributed in supermarkets in Spain | Sur in English

The Spanish agency for medicines and health products (AEMPS), which is part of the health ministry, has issued a warning regarding several sunscreens sold in supermarkets.

As published by AEMPS in a statement, the agency became aware, through a study conducted by the organisation of consumers and users (OCU), of alleged non-compliance in the labelling of seven sunscreens.

AEMPS requested the companies involved to provide tests supporting the SPF and FP-UVA claims, carried out according to official methods and in accordance with the European Commission Recommendation of 22 September 2006 on the efficacy claims of the sunscreen products.

Following the evaluation, AEMPS observed discrepancies between the results of the SPF and FP-UVA tests carried out by the OCU and the test results provided by the companies themselves. As the authority in the control of the cosmetic products market, AEMPS requested the companies take appropriate measures to cease marketing and withdraw the product from sale in each case.

It should be noted that in recent years a certain variability has been observed in the application of the technical standard UNE EN ISO 24444, which hinders the ability to accurately measure the SPF of sunscreens. This has been pointed out by the AEMPS in different official forums at European and international level, opening the debate on the need to reinforce the method to reduce its variability. Furthermore, the agency is also promoting a review of the information that appears on the labelling to indicate the sun protection factor.

Three of the companies against which the AEMPS took action have now provided additional studies to demonstrate that their products comply with the SPF and/or PF-UVA claimed in the labelling.

Based on these new results, the AEMPS has taken the following actions on these products:

VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+:

The company Cosmetique Active International has provided additional studies carried out on this product on a different batch than the one tested by the OCU:

Lot tested by the OCU: 54X200

Lot tested by the company: 54XN02

The reason why this company did not carry out the additional tests on the same batch tested by the OCU was that it did not have the necessary quantity of product to carry out these tests.

After a detailed analysis of all available information, AEMPS has decided to modify the measures previously adopted. As a result, it has been concluded that the product VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+ can continue to be sold, except for lot 54X200, for which the measure of cessation of marketing is maintained, as the company has not provided additional data on this lot.

The AEMPS, as reported in its previous information note, ordered the cessation of the marketing of the product and the withdrawal of batch 54X200 from the market.

BIOTHERM Waterlover Face Sunscreen SPF 50+

The company Prestige & Collections International has provided new studies carried out on the product, on a batch also different from the one tested by the OCU:

OCU tested lot: 40X300

Lot tested by the company: 40WD00

The reason why this company did not carry out the additional tests on the same batch tested by the OCU was that it did not have the necessary quantity of product to carry out these tests.

After a detailed analysis of all available information, AEMPS has decided to modify the previously adopted measures. As a result, it has been concluded that the product BIOTHERM Waterlover Face Sunscreen SPF 50+ can continue to be marketed, except for lot 40X300, for which the measure of cessation of marketing is maintained, as the company has not provided additional data on this lot.

The AEMPS, as reported in its previous information note, ordered the cessation of the marketing of the product and the withdrawal of batch 40X300 from the market.

ISDIN Fusion Water Magic SPF 50

In this case the alleged non-compliance concerned FP-UVA. The OCU has provided additional tests carried out on lot 30541F of the product using the official methods, namely one test according to UNE-EN ISO 24444, and one according to UNE-EN ISO 24443. Specifically, a test according to the UNE-EN ISO 24444 standard, and another according to the UNE-EN ISO 24443 standard. According to the results of the latter test, the FP-UVA value obtained would be lower than that claimed on the labelling.

ISDIN has also provided new studies carried out on batch 30541F. In this case, three tests according to the UNE-EN-ISO 24443 standard, the results of which support the FP-UVA claims of the labelling.

After a detailed analysis of all available information, AEMPS continues to consider that no action is necessary with regard to ISDIN Fusion Water Magic SPF 50.

AEMPS, as reported in its previous information note, did not take any action on this product, as the company provided two tests, both carried out with the official method, while the OCU used for the calculation of the FP-UVA a data obtained by an unofficial method currently under evaluation, so that the FP-UVA value obtained was not considered decisive for the decision to be taken.

Affected creams and measures taken

RITUALS Invisible Sun Protection Face Cream SPF 50+ RITUALS COSMETICS0832913: Stop the marketing of the product and withdraw lot 0832913 from the market.

NIVEA SUN Sensitive Face Protection SPF 50BEIERSDORF AG32032276: Cease marketing lot 32032276

LANCASTER Sun Sensitive Oil-Free Milky Fluid SPF 50 COTY S.A.S.3157: Cease marketing lot 3157.

PIZ BUIN Hydro Infusion Sun Gel Cream Face SPF 50 JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE (JJSBF)1362V A: To cease the marketing of lot 1362V A

VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+COSMETIQUE ACTIVE INTERNATIONAL54X200: Cessation of marketing lot 54X200

BIOTHERMWaterlover Face Sunscreen SPF 50+PRESTIGE & COLLECTIONS INTERNATIONAL40X300: Cease marketing batch 40X300

ISDINFusion Water Magic SPF 50Isdin SA.30541F: No action taken.

With regard to the product RITUALS Invisible Sun Protection Face Cream SPF 50+, AEMPS has been informed by the company that it is conducting additional tests on the product. As soon as the results of these tests are available, AEMPS will evaluate the information and update this information note if necessary. For the other products, AEMPS has not received additional studies.

It is important to note, however, that to date no sunburn incidents related to any of these products have been reported to the ‘Spanish Cosmetovigilance System’ which monitors and collects information about adverse effects or incidents related to cosmetic products.

AEMPS continues to investigate sunscreen products and will report promptly on any changes.