New FDA-approved Sunscreen Ingredient to Hit U.S. Shelves Within Months

The first sunscreens containing a newly FDA approved ingredient are likely to hit the market in the next two to three months.

On Tuesday, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients. This is the first new active ingredient added to the over-the-counter sunscreen monograph since the late 1990s.

In a statement, HHS Secretary Robert F. Kennedy Jr. said: “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.â€

Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.

David Andrews, chief science officer at Environmental Working Group, said: “For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward.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. This is a win that has been a long time coming.†

The ingredient has long been in a number of sunscreens in Europe and Asia and will mean that many brands sold in the U.S. can reformulate with this ingredient.

Dsm-firmenich, the Swiss fragrance and flavors supplier, has the 18 months’ exclusive marketing rights in the U.S. of Parsol Shield, a proprietary bemotrizinol formulation. 

In an interview, Parand Salmassinia, beauty and care president at Dsm-firmenich, said: “This ingredient has been used outside of the U.S. for more than 25 years safely. So, if the customers wanted to globalize the formulations, this is their moment, and the customers that we have been working with in North America, we told them, ‘this product is coming, we have the approval, we’ve been working very closely with the FDA,’ so a lot of these customers have formulations ready to go. I would say in the next two to three months you should be able to see this product and the formulations in the marketplace.â€

She called the approval a game changer for the brands she works with. “The U.S. market has very limited access to the type of a product that allows them to formulate a sunscreen that will feel like a skin care product, so now with this, this is a game changer, and a lot of the brands will be able to enter the market, or re-enter the market, or relaunch the product with something that actually feels great, and it’s fully safe, and it gives you a broad protection.â€

Still, many sunscreens in Europe, for example, contain ingredients not available in the U.S. such as Tinosorb M, Uvinul A Plus, and Uvinul T 150.