Friday, June 21, 2024, 2:52 p.m
The Spanish Agency for Medicines and Health Products (AEMPS), which is part of the Ministry of Health, has issued a warning about several sunscreens sold in supermarkets.
As AEMPS disclosed in a statement, the agency became aware of the alleged labeling discrepancy of seven sunscreens through a study conducted by the Organization of Consumers and Users (OCU).
AEMPS asked the participating companies to provide tests supporting the SPF and FP-UVA claims, carried out according to official methods and in accordance with the European Commission’s recommendation of 22 September 2006 on claims of the effectiveness of sunscreen products.
Upon evaluation, AEMPS found discrepancies between the SPF and FP-UVA test results performed by OCU and the test results provided by the companies themselves. As the body controlling the market for cosmetic products, AEMPS has asked companies to take appropriate measures to stop marketing and withdraw the product from sale in any case.
It should be noted that in recent years, some variability has been observed in the application of the technical standard UNE EN ISO 24444, which prevents the possibility of accurately measuring the SPF of sunscreens. This was pointed out by AEMPS in various official forums at European and international level, which opened a discussion on the need to strengthen the method to reduce its variability. In addition, the agency is also pushing for a review of the information that appears on the label to indicate the sun protection factor.
Three of the companies AEMPS took action against have now provided additional studies to demonstrate that their products meet the SPF and/or PF-UVA listed on the label.
Based on these new results, AEMPS has taken the following actions on these products:
VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+:
Cosmetique Active International provided additional studies conducted on this product on a different lot than the one tested by OCU:
Lot tested by OCU: 54X200
Batch tested by company: 54XN02
The reason this company did not perform additional tests on the same batch of OCU tested was that they did not have the necessary amount of product to perform these tests.
After a detailed analysis of all available information, AEMPS decided to modify the measures previously taken. As a result, it has been concluded that VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+ can continue to be sold, with the exception of lot 54X200, for which a stop-marketing measure is maintained, as the company did not provide further data on this plot.
AEMPS, as stated in its previous information notice, ordered the product to be discontinued and the 54X200 lot recalled from the market.
BIOTHERM Waterlover Face Sunscreen SPF 50+
Prestige & Collections International provided new studies done on the product, on a batch that is also different from the batch tested by OCU:
OCU tested batch: 40X300
Batch tested by company: 40WD00
The reason this company did not perform additional tests on the same batch of OCU tested was that they did not have the necessary amount of product to perform these tests.
After a detailed analysis of all available information, AEMPS decided to modify the measures previously taken. As a result, it has been concluded that BIOTHERM Waterlover Face Sunscreen SPF 50+ can continue to be marketed, with the exception of batch 40X300, for which the marketing termination measure is maintained, as the company did not provide further data on this lot.
AEMPS, as stated in its previous information report, ordered the product to be discontinued and the 40X300 lot recalled from the market.
ISDIN Fusion Water Magic SPF 50
In this case, the alleged non-compliance related to FP-UVA. OCU provided additional tests performed on batch 30541F of the product using official methods, namely one test according to UNE-EN ISO 24444 and one according to UNE-EN ISO 24443. Specifically, a test according to UNE-EN Standard ISO 24444 and another according to UNE-EN ISO 24443 According to the results of the latter test, the FP-UVA value obtained would be lower than that indicated on the label.
ISDIN also provided new studies performed on lot 30541F. In this case, three tests according to the UNE-EN-ISO 24443 standard, the results of which support the FP-UVA labeling claim.
After a detailed analysis of all available information, AEMPS continues to believe that no action is necessary with respect to ISDIN Fusion Water Magic SPF 50.
AEMPS, as stated in its previous informative note, did not take any action on this product because the company provided two tests, both performed by the official method, while OCU used an unofficial method to calculate the FP-UVA data, which is currently being evaluated, so 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 placing the product on the market and withdraw lot 0832913 from the market.
NIVEA SUN Sensitive Face Protection SPF 50 BEIERSDORF AG32032276: End marketing of lot 32032276
LANCASTER Sun Sensitive Oil-Free Milk Fluid SPF 50 COTY SAS3157: End marketing of lot 3157.
PIZ BUIN Hydro Infusion Sun Gel Cream Face SPF 50 JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE (JJSBF)1362V A: End sale of lot 1362V A
VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+COSMETIQUE ACTIVE INTERNATIONAL54X200: Stopping Marketing Plot 54X200
BIOTHERMWaterlover Face Sunscreen SPF 50+ PRESTIGE & COLLECTIONS INTERNATIONAL40X300: Stop marketing the 40X300 batch
ISDINFusion Water Magic SPF 50 Isdin SA.30541F: No action was taken.
Regarding RITUALS Invisible Sun Protection Face Cream SPF 50+, AEMPS has been informed by the company that it is conducting additional tests on the product. Once the results of these tests are available, AEMPS will evaluate the information and update this information if necessary. For other products, AEMPS has not received additional studies.
However, it is important to note that to date no cases of sunburn related to any of these products have been reported to the “Spanish Cosmetovigilance System”, which monitors and collects information on adverse effects or incidents related to cosmetic products.
AEMPS continues to investigate the sun protection products and will notify you promptly of any changes.