FDA

FDA reviewed the safety of octinoxate 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 octinoxate. These filters are approved around the globe and have been used in various formulations in the U.S. for decades. 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.

Octinoxate is listed as 2-Ethylhexyl 4-methoxycinnamatein Annex VI, entry 12 and may be used as a UV filterUV filters are ingredients that filter certain UV rays that are found in sunlight and, to a lesser degree, artificial light. UV filter is a general term that is used for sunscreen agents, ingredients used to protect the skin from UV rays, and ultraviolet light absorbers, ingredients use to protect products, packaging and hair from UV rays. in sunscreen products at a maximum concentration of 10% according to the Cosmetics Regulation of the European Union.

Ethylhexyl methoxycinnamate is approved as a safe and effective sunscreen ingredient in Canada, Australia and Japan.