AEMPS Information about market campaign control for sunscreen products

The Spanish Agency for Medicines and Health Products (AEMPS) started last December a market control campaign for sunscreen products, to guarantee that the sun protection factor (SPF) conforms to the one claimed in the labeling.

Guaranteeing such products effectiveness is the main goal and this market control action complements the measures that were taken last year, reflected in the COS information note, 7/2019 as well as in the COS information note, 4/2019.

The campaign encompasses the following:

  • Carrying out a triple analysis on samples of sunscreen products already present on the market: in vitro, in vivo and documentary of the efficacy studies conducted by the companies for the determination of the sun protection factor (SPF) stated on its labelling;

– The In vivo SPF determination analysis will be carried out in accordance with the technical standard ISO 24444: 2010 and ISO 24444: 2019.

  • 19 sunscreen products, coming from Spanish, EU and non-EU manufacturers, with an SPF 50 or 50+ on its label will be tested;
  • For the in vivo SPF analysis, the AEMPS will select by public procurement a laboratory that is experienced in both versions of ISO 24444 and that participates in an interlaboratory comparison study program for SPF testing;
  • The documentary analysis of the efficacy studies of the SPF and its correspondence with the one claimed in the labeling has been conducted already. However, to draw valid conclusions, it is necessary to compare them with the other two studies, which are still pending due to COVID-19.

Because of the current pandemic, the AEMPS calculates that the final report will be delayed until the beginning of 2021.

In any case, to ensure safe sun exposure, it is recommended to consult AEMPS Advice on sun protection.

Carlos Francisco Marín Barrios

Regulatory Affairs Department


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