If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.


Consumer Safety

US FDA questions safety of sunscreens, again

Agency requests safety, efficacy data for a dozen common chemical UV filters

by Britt E. Erickson
September 27, 2021

Chemical structure of oxybenzone.

The US Food and Drug Administration is reverting back to a 2019 proposal that requires sunscreen manufacturers to demonstrate that their active ingredients are generally recognized as safe and effective (GRASE). The agency announced its decision Sept. 24 in a proposed order that is intended to replace an order attached to the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act.

The CARES Act overhauled the FDA’s over-the-counter drug approval process and deemed several sunscreen ingredients as GRASE. The FDA had requested safety and efficacy data for 12 of those sunscreens in 2019, but under the CARES Act such data were no longer necessary. Now, the agency is once again asking for the data to demonstrate the substances are GRASE.

The sunscreen ingredients in question are avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, and sulisobenzone. Zinc oxide and titanium dioxide would maintain their GRASE status without additional data.

The FDA is seeking safety data for the 12 chemicals because new research shows that some of them are absorbed through the skin (JAMA 2020, DOI: 10.1001/jama.2019.20747). The Environmental Working Group (EWG), an advocacy organization, claims that some of the chemicals are potential endocrine disruptors.

“Sunscreen chemicals like oxybenzone pose significant health concerns, but the sunscreen industry continues to bury its head in the sand,” Scott Faber, the EWG’s senior vice president for government affairs, says in a statement. “We’re grateful the FDA continues to demand basic data on the health effects of these chemicals.”

A consortium of sunscreen manufacturers represented by the Personal Care Products Council is actively working to generate the data requested by the FDA in 2019. In a Sept. 16 letter to the FDA, the consortium summarizes progress made since then, including the development of clinical and nonclinical data for 8 of the 12 active ingredients.

The FDA emphasizes that any new requirements for sunscreens will not go into effect until at least one year after the proposed order is finalized. The agency is seeking comments on the proposal until Nov. 12.



This article has been sent to the following recipient:

Chemistry matters. Join us to get the news you need.