FDA approves new sunscreen ingredient bemotrizinol

The Food and Drug Administration has approved bemotrizinol for use in U.S. sunscreens, clearing the first new sunscreen ingredient for the American market in more than two decades and opening the door to a chemical UV filter already widely used abroad.

The agency announced Tuesday that bemotrizinol meets its standards for protection against dangerous ultraviolet rays while causing little irritation and showing low absorption into the skin. The FDA said the ingredient is safe for adults and children 6 months and older.

Bemotrizinol will initially be sold in the United States by Dutch manufacturer DSM Nutritional Products, also known as DSM-Firmenich, under the brand name Parsol Shield. The company said sunscreens containing the ingredient are expected to be available by the end of the year. After an 18-month exclusivity period, other manufacturers will be able to use it.

The approval has been closely watched because bemotrizinol has long been available in Europe, Australia and some Asian countries. European authorities authorized it in 1999, and the ingredient was first filed with the FDA for review in 2005. DSM later began a new round of studies requested by the FDA in 2019.

Health and Human Services Secretary Robert F. Kennedy, whose department includes the FDA, called the decision a step toward “advancing innovation” and expanding consumer choice.

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

Sunscreen filters are designed to block ultraviolet radiation. Broad-spectrum products protect against both UVA and UVB rays. UVA rays are linked to aging and wrinkles, while UVB rays cause sunburn; both contribute to skin cancer, according to dermatology and skin cancer organizations cited by NBC News.

The new ingredient is notable because it provides broad-spectrum protection on its own. Currently available chemical filters in the United States protect against either UVA or UVB rays, so companies typically combine ingredients to achieve broad-spectrum coverage. Mineral filters such as zinc oxide and titanium dioxide can block both UVA and UVB rays, but they often leave a chalky white cast on the skin.

Bemotrizinol is also more stable in sunlight than some existing chemical filters, NBC News reported, meaning it does not break down as readily in the sun. The FDA also cited its low level of absorption into the body. Concerns have been raised that some sunscreen ingredients may enter the bloodstream, though NBC News reported it remains unclear whether that is harmful.

Consumer and health advocates who have pushed for stronger sunscreen standards welcomed the move. The Environmental Working Group, which has urged the FDA to tighten sunscreen rules and allow newer ingredients, said bemotrizinol could help close gaps in UVA protection.

“This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens,” David Andrews, the group’s chief science officer, said in a statement.

Andrews also said the approval would help update the U.S. sunscreen market. “For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,” he said. “The approval of bemotrizinol will help change that.”

The decision follows years of delays tied to the FDA’s process for updating the list of safe nonprescription drug ingredients. Bemotrizinol is the first sunscreen ingredient to move through a streamlined review process authorized by Congress in 2020.

“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,” said Dr. Mike Davis, acting director of the FDA’s drug center.

The agency has updated sunscreen rules over time. In 2011, it barred labels such as “waterproof,” saying they were misleading, and required sunscreens to filter both UVA and UVB rays. In 2021, the FDA proposed additional changes, including limits on SPF numbers and stronger UVA protection requirements, but those measures have not been finalized.