The U.S. Food and Drug Administration (FDA) reviewed the safety of octocrylene and approved its use as an active ingredient sunscreen product. 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 octocrylene. 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.
Octocrylene is currently listed in Annex VI, entry 10, of the Cosmetics Regulation of the European Union. It may be used at a maximum concentration of 0.9% in propellant spray products and up to 10% in other products. The Annex also specifies that benzophenone must be kept at trace levels as an impurity and/or degradation product of octocrylene.
The EU’s Scientific Committee on Consumer Safety (SCCS) was asked to review new scientific data on octocrylene. It issued an opinion on its safety in June 2021, concluding that it is safe as a UV filter at concentrations of up to 10% in individual sunscreen products. Octocrylene is also considered safe for combined use with the following sunscreen products containing octocrylene at a concentration of up to 10%: body creams/lotions, sunscreen pump sprays, face and hand creams, and lipsticks. However, using octocrylene in sunscreen propellant spray products is considered safe only when its concentration does not exceed 9% when used in combination with those products.
While some studies indicate that octocrylene may have endocrine effects, the SCCS notes that current evidence is inconclusive for use in safety assessments. Additionally, the number of reported cases of allergic skin reactions from octocrylene is small, particularly when considering the widespread use of octocrylene in cosmetics and personal care products.
The SCCS also noted that reports of allergic skin reactions attributed to octocrylene when sunscreen use is combined with sun exposure were mainly seen in adult patients who had previously used topical products containing the anti-inflammatory drug ketoprofen. Therefore, it is probable that the reactions were due to prior sensitization to ketoprofen and not reactions to octocrylene.