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FDA Approves First New Sunscreen Ingredient in Two Decades
  • Posted June 10, 2026

FDA Approves First New Sunscreen Ingredient in Two Decades

The U.S. Food and Drug Administration (FDA) has approved bemotrizinol (BEMT) for use in over-the-counter sunscreen products.

Bemotrizinol is a chemical filter that absorbs both UVA and UVB radiation, the two primary types of ultraviolet rays that cause skin damage and increase cancer risk. 

It’s the first new sunscreen ingredient approved in the U.S. since the 1990’s. It has been used safely overseas for decades.

The FDA’s final order states that the new sunscreens containing bemotrizinol may come in the form of oils, lotions, creams, gels, butters, pastes, ointments, sticks or sprays (if certain spray-specific requirements are met). 

Unlike many chemical sunscreen filters on shelves today, bemotrizinol is highly photostable, meaning it breaks down much more slowly when exposed to intense sunlight. That means protection may last longer.

BEMT is also less likely to be absorbed into the body. While some older chemical filters used in U.S. sunscreen have been found to enter the bloodstream at levels that concerned regulators, BEMT stays mostly on the skin surface, according to USA Today.

Because it is unlikely to cause irritation, the FDA has cleared it for use on children as young as 6 months old. 

“Bemotrizinol would be the first chemical UV filter recommended to be used on infants due to minimal skin irritation," Dr. Nisha Varadarajan, a dermatologist at Memorial Sloan Kettering Cancer Center in New York City, told USA Today.

Health experts hailed the approval as a vital tool in the ongoing effort to reduce preventable skin cancers. 

“The [American Academy of Dermatology] believes this approval marks an important public health step by expanding access to safe and effective sunscreens for consumers in the United States and helping save the lives of Americans from skin cancer,” AAD President Dr. Murad Alam told USA Today.

Bemotrizinol has been used safely across Europe and other international markets for decades. 

By streamlining the approval process under the CARES Act, the FDA aims to give Americans more options. The proposed order was originally issued Dec. 12, 2025, six months ago.

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” Dr. Karen Murry, director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation and Research, said in a news release. 

“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,” she added.

Manufacturers will be permitted to start including bemotrizinol in their formulas beginning Aug. 9.  

It is expected to debut in the U.S. market exclusively under the brand name Parsol Shield this summer, according to USA Today. After 18 months, other manufacturers may market products with the new ingredient.

More information

The U.S. Food and Drug Administration has more about protecting your skin from the sun.

SOURCES: U.S. Food and Drug Administration, June 9, 2026; USA Today, June 9, 2026

HealthDay
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