Octisalate (Ethylhexyl Salicylate)
The U.S. Food and Drug Administration (FDA) reviewed the safety of octisalate 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 octisalate. These filters are approved around the globe and have been used in formulations in the U.S. for decades. Importantly, 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 reviewed ethylhexyl salicylate on several occasions. In 2003, the Expert Panel evaluated available scientific data and concluded that salicylic acid and 16 other salicylates, including ethylhexyl salicylate, are safe when formulated to avoid skin irritation and increase the skin’s sun sensitivity.
In 2019, the Expert Panel conducted a routine re-evaluation. Once again, it concluded that salicylic acid and other salicylates, including ethylhexyl salicylate, are safe as used when formulated to be non-irritating and non-sensitizing. This conclusion may be based on a quantitative risk assessment (QRA) and supersedes the earlier 2003 conclusion.
Ethylhexyl salicylate/octisalate, is listed in Annex VI, entry 20 and may be used as a UV filter in sunscreen products at a maximum concentration of 5% according to the Cosmetics Regulation of the EU.