Sunscreen Ingredient the U.S. May Finally Approve After Decades

Essential Points

• New Ingredient: The FDA is proposing to allow bemotrizinol in sunscreens.
• Safety Record: Bemotrizinol has been used safely in other countries for over two decades.
• Regulatory Update: The FDA aims to modernize sunscreen regulations for better consumer options.
• Stability: Unlike some current chemical sunscreens, bemotrizinol remains stable when exposed to sunlight.

Sunscreens in the United States might soon be able to include a new ingredient.

On Thursday, the U.S. Food and Drug Administration announced that it is proposing to permit bemotrizinol as an active ingredient in sunscreens. Information reviewed by the agency indicates that bemotrizinol protects against ultraviolet A and B rays, very little of it is absorbed by the body through the skin, and it rarely irritates the skin. If this motion goes through, it would be another active sunscreen ingredient broadly considered safe and effective by the FDA for adults and children over the age of six months.

What other countries have approved bemotrizinol?

“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 said in an FDA statement.

Over-the-counter (OTC) monograph drugs like sunscreen can be sold without an approved drug application if they fulfill certain criteria, including rules dictated by their monograph. A monograph is a set of conditions (like active ingredients and doses) for a therapeutic category under which an OTC drug is “generally recognized as safe and effective.” OTC monograph drug categories include sunscreens, antacids, allergy medications, laxatives, and so on.

“Bemotrizinol has been approved in Europe, Australia, Japan and other countries for more than two decades, and it has a steadfast track record for safety and tolerability,” Sairekha Ravichandran, a dermatologist at the Moffitt Cancer Center, said in a statement published by the center after the FDA’s announcement. “One drawback of some chemical sunscreens we have now is that they can become unstable and break down when exposed to sunlight,” she added. “But not bemotrizinol. This is a very stable sun filter that may even help to stabilize other unstable filters when added to a sunscreen formulation.”

What are the proposed concentrations of bemotrizinol?

According to the agency, DSM Nutritional Products LLC—a company that manufactures products for the pharmaceutical and cosmetic industries, among others—filed a request for the FDA to add bemotrizinol concentrations of 6% or less as a new active ingredient in the OTC monograph for sunscreens.

“The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process,” Karen Murry, Acting Director of the Office of Nonprescription Drugs, said in the FDA statement. “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.”