The Food and Drug Administration on Monday approved the first new active ingredient for over-the-counter sunscreens in more than 20 years, giving American consumers access to a product that has been widely available in Europe, Asia, and countries in other regions for decades.
The agency added bemotrizinol to its sunscreen monograph at concentrations of up to 6 percent. Bemotrizinol is the first approved chemical sunscreen filter that offers broad-spectrum protection against both UVA and UVB rays, the FDA said. It also demonstrates low levels of absorption through the skin, making it safer for young children, and it rarely causes irritation.
The FDA determined that the organic chemical is generally recognized as safe and effective for adults and children 6 months and older.
As a chemical sunscreen filter, the newly approved ingredient allows for sunscreens with a lighter, more user-friendly texture than existing mineral sunscreens for UVA and UVB protection, according to the FDA.
Health Secretary Robert F. Kennedy Jr. portrayed the decision as part of the Trump administration’s Make America Healthy Again (MAHA) initiatives.
“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” Kennedy said. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
The Skin Cancer Foundation praised the approval.
“Increasing access to innovative sun protection tools is an important step toward improving sun-safe behaviors and reducing the burden of skin cancer in the United States,” the foundation’s president, Dr. Deborah S. Sarnoff, said in a statement.
Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said the approval demonstrates a willingness among regulators to modernize processes in line with the latest advancements in science.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” Davis said in a statement. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
Office of Nonprescription Drugs Director Dr. Karen Murry said the move will give consumers confidence in the new products.
“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Murry. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”
The final order came seven months after the FDA proposed the addition in December 2025. It marks the first time the streamlined process created by the CARES Act has been used to add a new active ingredient to an over-the-counter product. DSM Nutritional Products LLC submitted the request.
For years, U.S. sunscreen options lagged behind those available abroad. No new active ingredients had been added to the monograph since the late 1990s. In the December proposal, then-FDA Commissioner Marty Makary noted that the agency had historically moved too slowly in this area, leaving Americans with fewer choices than consumers in other countries.
The new ingredient is expected to support broader sunscreen innovation. Officials said it aligns with efforts to improve regulatory processes for over-the-counter products that have fallen behind international standards.
Broad-spectrum sunscreens with SPF 15 or higher, when used as directed along with protective clothing and limited sun exposure, help prevent sunburn and reduce the risks of skin cancer and early skin aging. The FDA said Americans should combine sunscreen with other sun-safety measures.
The agency considered public comments submitted after the December proposal ahead of issuing Monday’s decision.
The action is part of a broader framework to modernize nonprescription drug regulation. Officials noted the CARES Act reforms mean companies can bring new active ingredients to market in a more efficient manner than under past procedures, as long as the data point toward a finding of general recognition of safety and effectiveness.