The U.S. Food and Drug Administration announced last week it is proposing the addition of bemotrizinol as a permitted active ingredient in over-the-counter sunscreens, part of a broader effort to modernize the regulation of nonprescription drugs.

According to a news release, bemotrizinol, already used in sunscreen products in many countries, provides protection against both ultraviolet A and B rays, shows low absorption through the skin, and rarely causes irritation, according to FDA data. If finalized, the ingredient would be considered generally recognized as safe and effective for adults and children 6 months and older.

“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA Commissioner Marty Makary, M.D., M.P.H. said in teh release. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”

Sunscreens regulated under the FDA’s over-the-counter monograph system can enter the market without an approved drug application if they meet established conditions, including permitted active ingredients, uses, and doses. The agency can update these monographs through proposed and final administrative orders, a process that can be initiated by a drug company submitting an OTC Monograph Order Request.

DSM Nutritional Products LLC submitted a request to add bemotrizinol at concentrations up to 6% to the OTC sunscreen monograph. While the ingredient has been widely used internationally, it has not previously been approved in the U.S. or added to the sunscreen monograph.

The FDA emphasizes that broad-spectrum sunscreens with SPF 15 or higher help prevent sunburn and reduce the risk of skin cancer and premature skin aging, especially when combined with other protective measures, such as wearing protective clothing and limiting sun exposure.

“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” said Karen Murry, M.D., Acting Director of the Office of Nonprescription Drugs. “The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process, and we look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past.”

The FDA is accepting public comments on the proposed order. Instructions for submitting comments are available at https://tinyurl.com/52nx4v5y. If the agency determines bemotrizinol is generally recognized as safe and effective, a final order will be issued to add the ingredient to OTC Monograph M020.