US FDA approves first sunscreen ingredient in over two decades

The US Food and Drug Administration (FDA) has permitted its first sunscreen active after two decades of inaction. The US beauty industry has been pushing for approval of a new sunscreen active since the FDA’s last accepted ingredient in the late 1990s. 

Bemotrizinol, also known as BEMT, can now be used in sunscreens in the US. The ingredient has been marketed as a sunscreen ingredient in many countries globally for years. 

“As promised in the Trump Administration’s MAHA (Make America Healthy Again) Strategy Report, Health and Human Services (HHS) is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years,” says HHS Secretary Robert F. Kennedy, Jr. 

“Bemotrizinol has been used safely in Europe for decades, and the FDA’s action will increase competition and consumer confidence in sunscreen products.”

Regulatory roadblock opens 

Unlike other countries, in the US, sunscreens are regulated as over-the-counter (OTC) drugs, not cosmetics. Most of the world treats them as beauty products, leading to faster and more regular approval of new solutions.

“While some countries regulate sunscreens differently (for instance, as cosmetics), in the US, sunscreens are an FDA-regulated drug product, which means they must meet standards related to the safety and effectiveness of over-the-counter drug products in the US,” an FDA spokesperson previously told Personal Care Insights.

Bemotrizinol is the first new active ingredient added to an OTC monograph under the process established by the CARES (Coronavirus Aid, Relief, and Economic Security) Act.Bemotrizinol becomes the first FDA-approved sunscreen active in over 20 years. 

“The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process,” said Karen Murry, acting director of the Office of Nonprescription Drugs, ahead of the approval.

Last year, DSM Nutritional Products submitted an OTC Monograph Order Request to the FDA to add BEMT at concentrations up to 6% as a new active ingredient in over-the-counter sunscreens. dsm-firmenich has been pushing to get bemotrizinol approved for the US market for over two decades, spending approximately US$20 million to do so.

Personal Care Insights recently spoke to Vicki Barboiu, senior director Beauty & Care North America at dsm-firmenich, about Parsol Shield, the company’s branded UV filter that has now become the first approved by the US FDA in over 25 years. 

She explained what the anticipated approval means for formulators and consumers and how it addresses the US broad-spectrum SPF gap.

Closing UV protection gaps

The Environmental Working Group (EWG) says BEMT will give American consumers access to a level of ultraviolet A (UVA) protection that has been unavailable in the US. 

“This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in US sunscreens,” says David Andrews, chief science officer at EWG.

“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that. The FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves.”

Bemotrizinol offers a stable non-mineral solution that does not break down in the sun, unlike one of two previously approved UVA filters, avobenzone. 

“Bemotrizinol changes the calculus of sun care. It is highly photostable, meaning it won’t break down when [the] hot summer sun hits your skin — unlike avobenzone, currently the only non-mineral filter in the US that provides meaningful UVA coverage,” says Alexa Friedman, senior scientist at EWG.

Traditional US sunscreens block the radiation that causes visible sunburns, ultraviolet B rays. But, according to the EWG, they routinely fail to shield against deep-penetrating UVA rays. UVA rays contribute to premature aging, suppress the immune system, and are the primary contributor to skin cancer, according to the American Cancer Society. 

Skin cancer is the most common cancer in the US. EWG’s peer-reviewed research found that US sunscreens deliver on average 24% of the UVA protection implied by their SPF labels. 

“For too long, American consumers have been applying sunscreen and believing they were fully protected, not knowing that their product was delivering far less UVA protection than the label implied,” highlights Friedman.

Yesterday’s approval thereby marks “the most significant step in a generation toward fixing that problem,” says EWG. dsm-firmenich's Parsol Shield is now approved by the FDA.

Mike Davis, acting director of the FDA Center for Drug Evaluation and Research, adds: “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.” 

Industry impact

BEMT’s approval marks a potential turning point for the US personal care industry. 

Formulators gain access to a highly photostable, broad-spectrum UV filter that has been a staple in European and Asian sunscreens for years. This narrows an innovation gap that has constrained US sun care.

Suppliers and brands can now develop formulations with stronger UVA protection, potentially reshaping competition across the category. Premium and “clean beauty” lines, in particular, may move quickly to reformulate around the active.

The approval also validates the CARES Act’s monograph pathway, offering a clearer route for future actives to reach the US market. Other long-stalled filters could follow.

For an industry frustrated by years of regulatory stagnation, dsm-firmenich’s approval may signal the start of renewed investment, reformulation, and innovation in American sun care.