The FDA reviewed the safety of avobenzone and approved its use as an active ingredient in OTC 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 avobenzone.
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.”
These filters are approved around the globe and have been used in various formulations in the U.S. for decades.
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.
Avobenzone is listed as 1-(4-tert-butylphenyl)-3-(4-methoxyphenyl) propane-1,3-dione in Annex VI, entry 8 (which specifies the UV filters cosmetics products may contain) of the Cosmetics Regulation of the European Union. It may be used at a maximum concentration of 5% in cosmetics and personal care products, including sunscreens products.