The Spanish Agency for Medicines and Health Products has ordered the cessation of marketing, the withdrawal from the market of the units distributed and the recovery of the units purchased by users of all batches of the cosmetics Arual Activador Solar and Kream Bloody Mary Intensificador del Bronceado.
The AEMPS argues its decision on the grounds that it is not possible to guarantee the safe use of both products and that they could become a serious health risk.
The agency states that, after reviewing the safety assessment of the cosmetic, it has been confirmed that the responsible person has not provided any stability study that allows to establish an expiry date or period after opening (PAO), as well as to guarantee the safe conditions of transport, storage and preservation.
The supplier of the raw material with tanning activator function states that ‘it is essential to warn that the Tanning Accelerator has no UV filtering power and must therefore always be accompanied by a sunscreen’, but this warning is not present on the labelling of the product.