FDA approves the first new sunscreen ingredient in 20 years

The Food and Drug Administration expanded the list of sunscreen ingredients for the first time in more than 20 years.

The FDA approved bemotrizinol (BEMT) on June 9, making it the newest active sunscreen ingredient available in the United States.

BEMT was developed during the late 1990s in Switzerland, according to the American Chemical Society. It has been used in sunscreens across the European Union, Asia, Australia and Canada for years.

The chemical made its way to the U.S. after the Swiss company, dsm-firmenich, submitted an application to make the ingredient available for over-the-counter (OTC) drugs on Sept. 23, 2024, according to the Federal Register.

More than 17 months later, the FDA approved dsm-firmenichs brand-name version of BEMT, Parsol Shield. The federal agency says that BEMT offers an effective, user-friendly option for sun protection.

Based on the data reviewed by the FDA, bemotrizinol provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body and rarely causes skin irritation, the FDA said in a press release.

Like other chemical sunscreens, BEMT works by absorbing the suns ultraviolet rays, thereby preventing burns, DNA damage and even premature skin aging. But unlike its chemical counterparts avobenzone, for example BEMT offers one advantage: It remains stable when exposed to sunlight.

Brands such as La Roche-Posay and Bioderma already have BEMT formulas available outside of the U.S. However, dsm-firmenich will hold the monopoly on BEMT sunscreen inside the country for the next 18 months. This is because Parsol Shield is protected under the Coronavirus Aid, Relief and Economic Security (CARES) Act.

In March 2020, President Trump signed the CARES Act, which sought to reform the regulation of OTC drugs. The U.S. Government Accountability Office (GAO) wrote that this act makes it easier for the FDA to update its guidelines on OTC drugs. It also incentivizes manufacturers to innovate by providing exclusivity protections, he said.

If FDA makes the requested changes to an OTC monograph, the requestor will receive 18 months of exclusivity to market their OTC drug incorporating the requested change, the GAO wrote.

The FDA claims the introduction of BEMT products aligns with the Trump Administrations priorities outlined in the Make America Healthy Again (MAHA) Strategy Report.

FDA will promote innovation in the sunscreen market and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries, the MAHA strategy report states.

Parand Salmassinia, beauty & care president at dsm-firmenich, says the approval benefits manufacturers and consumers. She looks forward to the future of sun protection in the U.S.

After more than two decades, this new active ingredient delivers what our customers have been waiting for, Salmassinia stated in a dsm-firmenich press release. It gives suncare manufacturers the flexibility to develop next-generation, globally scalable solutions that enhance the consumer experience.

The products containing Parsol shield will be released as early as September or October of this year.