AEMPS Investigates Sunscreen Labeling Discrepancies and Takes Regulatory Actions

March 21, 2024

The Spanish Agency for Medicines and Medical Devices (AEMPS) has discovered alleged breaches in the labeling of seven sunscreens, as per a study by the Organization of Consumers and Users (OCU). The AEMPS has requested documentation from the companies marketing these products and has taken measures to cease marketing and withdraw from the market appropriate to each case. The sunscreens in the European Union are considered cosmetic products and must comply with health guarantees established in legislation. The AEMPS has requested companies to provide tests supporting the claims of sun protection factor (SPF) and ultraviolet protection factor-A (FP-UVA) and has observed discrepancies between the results of the tests provided by the OCU and the results of the tests provided by the companies involved. The AEMPS has requested the companies to withdraw the tested batches from the market and cease marketing of the products.

Following Products claimed "Very High Sun protection category but on test performed by OCU obtain result in the category of "High"
RITUALS Invisible Sun Protection Face Cream SPF 50+
VICHY Capital Soleil Crème Onctueuse Protectrice SPF 50+
BIOTHERM Waterlover Face Sunscreen SPF 50+

Following Products claimed "High" Sun protection category, test performed by OCU also obtain result in the category of "High" but numerical SPF values not matched.
NIVEA SUN Sensitive SPF 50 Face Protection
LANCASTER Sun Sensitive Oil-Free Milky Fluid SPF 50
PIZ BUIN Hydro Infusion Sun Gel Cream Face SPF 50

Whereas, ISDIN Fusion Water Magic SPF 50 faces alleged non-compliance with FP-UVA, but has provided two tests and several essays supporting its claims. The AEMPS has not taken action against the product due to unofficial methods.

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