Sunscreen in the United States is about to get a long-awaited glow-up with the Food and Drug Administration’s decision to approve a new ingredient that has been used in other countries for years.
The FDA announced a proposal on Thursday to approve the ingredient bemotrizinol, a broad-spectrum chemical UV filter that has long been available in Europe, Australia, and some Asian countries.
FDA Commissioner Dr. Marty Makary said in a press release that, historically, the agency has “moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” tying the approval to the Make America Healthy Again promise of improving American innovation.
“We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” Makary said. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
Bemotrizinol blocks both forms of ultraviolet rays from the sun — UVA rays, which cause wrinkles and aging reactions, and UVB rays, which cause sunburns.
Currently in the U.S., most sunscreen products are mineral sunscreens that contain zinc oxide or titanium dioxide, which block both UVA and UVB rays but can leave a white cast on skin. Chemical filter sunscreens available in the U.S. do not offer broad-spectrum protection against both UVA and UVB radiation, protecting only one or the other.
The main reason why the U.S. has fallen behind other markets in terms of sunscreen innovation is that it is classified as an over-the-counter drug, as opposed to a cosmetic product. That means new sunscreen ingredients require clinical trials to test for safety and efficacy before they can be approved.
The FDA announced that bemotrizinol’s safety testing proved that the chemical has low levels of absorption into the body through the skin and rarely causes irritation.
The agency said the new sunscreen can be brought to market without a drug application if it meets certain procedural requirements. The FDA has to make the proposal and open the required public comment period before it can issue a final order to add bemotrizinol to the list of allowed sunscreen products.
Dr. Karen Murry, acting director for the FDA’s Office of Nonprescription Drugs, in a press release called bemotrizinol “a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers.”
The U.S. has not approved a new sunscreen ingredient for 25 years.
Sunscreen reform is one of the more often overlooked issues in the MAHA agenda promoted by Health and Human Services Secretary Robert F. Kennedy Jr., but it fits into the theme of improving ingredient safety and limiting toxic chemical exposures.
The MAHA Commission’s strategy report, published in September, included sunscreen reform in its list of more than 128 action items to improve children’s health and decrease rates of chronic disease in the U.S.
The report said the FDA would “promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”
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Rep. Alexandra Ocasio-Cortez (D-NY) in 2023 posted on social media that sunscreen standards in the U.S. had fallen behind those of South Korea, Japan, and the European Union, all of which are known among beauty influencers for having higher standards for cosmetic products than the U.S.
Two years ago, Ocasio-Cortez told the New York Times that working with the FDA to update the sunscreen regulation process had been difficult and that officials in Congress were not tuned in to the issue.
