The U.S. Food and Drug Administration (FDA) reviewed the safety of homosalate and approved its use as an active ingredient in sunscreen products. Sunscreens are regulated by the FDA as non-prescription, OTC drugs.
In February 2019, the FDA published a proposed rule requesting additional data on certain currently used sunscreen ingredients, including homosalate. Importantly, the FDA emphasized in a Sept. 27, 2021, announcement that sunscreens made with these ingredients are not considered unsafe and will remain on the market to be used as part of consumers’ sun-safe practices while more data are collected.
According to the FDA: “Sun safety is important for everyone and all skin tones, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen.”
The Personal Care Products Council (PCPC) and its member companies that manufacture sunscreen products have been working closely with the FDA to collect additional data that will address FDA’s request.
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety (Expert Panel) has deferred evaluation of this ingredient because the safety has been assessed by the FDA. This deferral follows the Expert Panel’s procedures.
The EU’s Scientific Committee on Consumer Safety (SCCS) was asked to review new scientific data on homosalate and issued an opinion on its safety in June 2021. Taking into account concerns related to potential endocrine-disrupting properties, the SCCS concluded that homosalate is safe for consumers up to a maximum concentration of 0.5% in the final product. The SCCS noted that currently available evidence for potential endocrine-disrupting properties of homosalate was inconclusive and misleading. The SCCS considered that while there were indications from some studies suggesting it may influence the endocrine system, the evidence was not conclusive enough to use in safety assessments.
In a separate opinion in December 2021, the SCCS concluded that, based on a new safety assessment specific to the use of homosalate in face products, it is safe as a UV filter at concentrations up to 7.34% in face cream and pump spray products.
Until the EU changes the Annex VI regulation of homosalate as a UV filter based on SCCS opinions, it may continue to be used at a maximum concentration of 10% in sunscreens.