Reed’s Law Leads to FDA Approving the First New Sunscreen Ingredient in 25 Years

WASHINGTON, DC - The future of American sunscreen products just got a little brighter - and safer and more effective too, thanks in part to the Sunscreen Innovation Act, a law authored by U.S. Senator Jack Reed (D-RI) to help companies avoid needless regulatory roadblocks.

For decades, European, Asian, and Australian consumers have had access to a wide variety of innovative, popular sunscreen products that are safe, effective, and more appealing to users than many sunscreens that are approved for use in the United States.

But now, thanks to Reed's Sunscreen Innovation Act, for the first time in over twenty-five years, the U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient - bemotrizinol, or BEMT - that dermatologists and skin care experts say is a safer option than many chemical ingredients currently in use in the United States.

The FDA's approval of BEMT brings the list of approved active sunscreen ingredients in the U.S. to 17 -- a number that still lags behind the 30 approved for use in Europe, which have demonstrated a strong record of safety.

"After years of work it is great to see real progress being made when it comes to new sunscreens for American consumers. This is a major step forward that could help prevent countless cases of skin cancer and better protect Americans from sun damage," said Senator Reed. "It's still up to consumers to choose which sunscreen is right for them, but I am pleased to help ensure Americans have more safe, healthy, proven options."

Reed's years-long campaign for stronger sunscreen standards and labeling was designed to address a regulatory backlog that prevented U.S. consumers from having access to advanced, effective sunscreens that are widely available in the rest of the world.

Bemotrizinol has been used safely in sunscreens across Europe and Asia since 1999 under brand names including Tinosorb® S by BASF and Parsol® Shield by DSM. The ingredient has amassed a 27-year safety track record abroad, though some of those jurisdictions have weaker data requirements than the United States.

Sunscreens with BEMT are expected to be available for sale in the U.S. and on store shelves later this month. According to the Associated Press, the Dutch-based company DSM Nutritional Products LLC will be the first company in the U.S. to sell BEMT-formulated sunscreen by manufacturer, Parsol Shield. The company has an 18-month exclusivity period, after which the other manufacturers may also use and market BEMT in their products.

Senator Reed says that regardless of what brand of sunscreen people use, he just wants to make sure it is safe, effective, and accessible.

"The best sunscreens are the ones that people actually like to wear," said Senator Reed.

The Environmental Working Group, a non-profit that champions effective sunscreen regulations, praised the FDA's long overdue move and said the approval of bemotrizinol offers a "landmark decision for public health and consumer protection."

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