FDA Approves New Sunscreen Ingredient After More Than 25 Years

For the first time in more than two decades, the U.S. Food and Drug Administration has approved a new sunscreen ingredient, marking a significant shift in American sunscreen regulation and potentially expanding options for consumers seeking broader sun protection.

The ingredient, bemotrizinol — also known as BEMT — has been widely used in Europe, Asia and other international markets since the late 1990s. It is already found in sunscreen products sold in countries including Israel, France, Japan and South Korea. The FDA’s decision highlights how the United States has lagged behind many global markets in approving newer sunscreen technologies.

FDA Clears Bemotrizinol for U.S. Market

Bemotrizinol protects against both UVA and UVB radiation and is considered photostable, meaning it remains effective when exposed to sunlight. The ingredient has been approved for use in adults and children older than six months at concentrations of up to 6%.

U.S. Health Secretary Robert F. Kennedy Jr. said the ingredient “has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

The approval also aligns with the Trump administration’s “Make America Healthy Again” initiative, which includes efforts to modernize FDA processes and encourage innovation in consumer health products.

Why U.S. Sunscreen Products Have Faced Criticism

Dermatologists and consumer advocacy groups have long argued that many sunscreen products sold in the United States provide weaker UVA protection compared to products available overseas.

Chemical sunscreen filters work by absorbing ultraviolet radiation and converting it into heat. However, many chemical ingredients currently approved in the U.S. are more effective at blocking UVB rays, which cause sunburn, than UVA rays, which penetrate deeper into the skin and are associated with skin cancer, premature aging and immune system damage.

Mineral sunscreens, typically made with zinc oxide or titanium dioxide, sit on the surface of the skin and physically reflect UV radiation. Because they are not significantly absorbed into the body, they are generally viewed as less irritating for sensitive skin.

A study from the Environmental Working Group found that U.S. sunscreen products provide, on average, only 24% of the UVA protection consumers might expect based on SPF labeling alone.

Bemotrizinol Could Improve Broad-Spectrum Protection

Experts say bemotrizinol helps address one of the biggest gaps in American sunscreen formulations.

Unlike avobenzone — currently the primary UVA-protecting chemical filter widely used in U.S. sunscreens — bemotrizinol does not quickly degrade in sunlight. It can also be combined with mineral ingredients like zinc oxide to improve broad-spectrum protection while reducing the heavy white residue often associated with mineral sunscreens.

“Unlike the older non-mineral filters, it can be combined with zinc oxide to provide strong broad spectrum protection with less white cast,” said Alexa Friedman, senior scientist at the Environmental Working Group.

Out of 550 sunscreen products recommended in the EWG’s 2026 report, 497 were primarily mineral-based, reflecting ongoing concerns about the limitations of older chemical sunscreen ingredients.

Decades of Regulatory Delays

Bemotrizinol was approved in Europe in 1999 and was first submitted to the FDA for approval in 2005. The process stalled for years due to the FDA’s lengthy review system for over-the-counter drug ingredients.

The ingredient ultimately became the first sunscreen active ingredient reviewed under an accelerated pathway authorized by Congress in 2020.

“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Dr. Mike Davis, acting director of the FDA’s drug evaluation center.

The delay also reflected broader concerns about sunscreen safety in the United States. In 2019, FDA researchers found that several common chemical sunscreen ingredients could enter the bloodstream at levels that raised safety questions after only one day of use.

According to the FDA study, ingredients including homosalate and oxybenzone remained in the bloodstream above recommended safety thresholds for more than two weeks after sunscreen application stopped. Those ingredients have not yet undergone full regulatory re-evaluation.

“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that,” said David Andrews, chief scientist at the Environmental Working Group.

Sunscreen Industry Welcomes FDA Decision

Dutch manufacturer DSM Nutritional Products will initially market bemotrizinol in the United States under the brand name Parsol Shield later this year. Other sunscreen manufacturers will be allowed to use the ingredient after an 18-month exclusivity period expires.

Industry groups praised the FDA’s decision but said further reforms are still needed.

A spokesperson for the Personal Care Products Council said, “While we commend FDA for this progress, continued efforts are needed to establish a more efficient and modern approach for approving additional sunscreen active ingredients.”

Broader proposals to modernize sunscreen labeling requirements and SPF regulations, first introduced in 2019 and published in 2021, still have not been finalized.

What Consumers Should Know

For many Americans, bemotrizinol may sound new, but international travelers have likely already used it without realizing it.

The ingredient is commonly listed as “Bemotrizinol” or “Tinosorb S” on sunscreen labels sold in Europe and Asia. Consumers purchasing sunscreen abroad — particularly in countries such as France, Japan, South Korea or Israel — may already be familiar with formulations containing the ingredient.

Health experts continue to emphasize that daily sunscreen use remains one of the most effective ways to reduce the risk of skin cancer and long-term sun damage.

The FDA’s approval of bemotrizinol signals a potential turning point for the U.S. sunscreen market, bringing American consumers closer to the broader range of advanced sun protection products already available worldwide.

Ernest Hemingway

“Lifelong entrepreneur. Total writer. Internet ninja. Analyst. Friendly music enthusiast.”