US catches up to rest of world with first new FDA-approved sunscreen in decades

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The Food and Drug Administration (FDA) this week approved the first new sunscreen filter in more than two decades, sparking industry wide excitement. And while this ingredient will be new to the U.S., it’s far from new to the market internationally.

The FDA broke a 27-year dry spell on Tuesday when it added bemotrizinol, sold under the brand name PARSOL® Shield, to its list of permitted sunscreen active ingredients. In December, the agency had indicated plans to approve bemotrizinol, with former FDA Commissioner Marty Makary saying at the time that action had “moved too slowly in this area.”

The ingredient has been available in Europe since 2000.

The approval request was submitted by the Swiss-Dutch multinational company DSM-Firmenich. The company will have exclusive marketing rights to bemotrizinol for the first 18 months after it’s approved. As an ingredient manufacturer, it will be the sole supplier of this filter for that time, and at least one company has confirmed plans to incorporate bemotrizinol into its product line.

The American Academy of Dermatology lauded the new approval, saying in a statement, “The FDA announcement follows longstanding and ongoing advocacy by the American Academy of Dermatology Association to ensure that U.S. consumers have more options to protect themselves from the sun’s harmful UV rays.”

Here’s what to know about bemotrizinol:

What is bemotrizinol?

UV filters fall into two categories: mineral sunscreens like zinc and titanium oxide, and chemical filters, also referred to as organic filters.

Bemotrizinol falls into the latter category. Unlike most other organic filters available on the U.S. market, bemotrizinol is a broad-spectrum filter, meaning it protects against both UVA and UVC radiation.

While mineral filters are very stable, they’re cosmetically inelegant, often leaving a well-known white cast on the skin. Organic filters, while clear, have oily textures and some — like avobenzone, the only other broad spectrum organic filter in the U.S. — are not very stable when exposed to UV radiation.

According to Gabriella Baki, director of the BSPS cosmetic science and formulation design program at Toledo University, bemotrizinol has several qualities that make it more attractive.

“A lot of our UV filters can only protect against either UVB or UVA radiation,” Baki noted. “Where we fail is that consumers don’t want to use the product because of what they feel like or look like on the skin, don’t want to reapply those products.”

Baki also noted that organic filters are known to seep into the bloodstream when applied topically. She emphasized that while this doesn’t mean the product is harmful, this reality is often another deterrent for consumers when shopping for sunscreens.

“This new ingredient, we know that it doesn’t absorb into the skin, or definitely not as much,” said Baki, adding that its texture is more pleasing than other filters in the U.S.

One other distinction that sets bemotrizinol apart from other organic filters is that it is Generally Recognized As Safe and Effective (GRASE) by the FDA. Other chemical filters like avobenzone, octocrylene, homosalate and oxybenzone are permitted for use in the U.S. but lack GRASE recognition.

Mineral sunscreens in the U.S. are considered GRASE.

Why more than 20 years?

The FDA is globally regarded as having the gold standard when it comes to drug approval processes, leaving some experts wondering why it took a nearly 30 years to approve a better-performing sunscreen filter.

According to Jessica O’Connell, a partner at Covington & Burling and co-chair of the firm’s Food, Drug, and Device Practice Group, the FDA simply held the position that it did not have the resources to fully review new filters.

For much of the past few decades, the FDA used what is called the Time and Extent Approach (TEA) pathway for approving over-the-counter drugs, which sunscreens fall under.

“This ingredient in particular was the subject of a Time and Extent application that just kind of lingered for quite some time with FDA, and I think FDA kind of historically said we don’t have the resources to really review these,” said O’Connell. “I think there were some questions around whether FDA thought the data that had been submitted was enough.”

This decades-long stall hadn’t gone unnoticed by Congress, and legislative efforts were made to overcome this pause.

The Sunscreen Innovation Act, enacted in 2014, was designed to provide an alternative pathway for reviewing the safety and efficacy of sunscreen ingredients. Despite the intention behind the bill, it ultimately did nothing to move the needle.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ended up being what ultimately got new filters moving through the FDA.

“There was more incentive for FDA to dedicate resources to reviewing these submissions, because their user fees tied to it, and so it created the process that DSM used for this particular submission,” said O’Connell.

The bipartisan SAFE Sunscreen Standards Act signed into law last year built off the provisions in the CARES Act and directed the FDA to streamline its review process specifically for active sunscreen ingredients.

Who’s selling it?

Companies will be able to start incorporating bemotrizinol into their sunscreen products beginning on Aug. 9, 2026.

The Hill reached out to major personal care manufactures, including the makers of sunscreens like Coppertone, Banana Boat and L’Oréal, for comment on plans to license and sell bemotrizinol-containing products in the U.S. but did not immediately hear back.

When reached for comment on which companies it may be partnering with, DSM-Firmenich also did not respond.

Kenvue, the owner of skincare brands like Neutrogena and Aveeno, confirmed plans to include bemotrizinol in its products.

“Once the bemotrizinol order is effective later this year, Neutrogena will integrate this filter into its sunscreen innovation pipeline, leveraging its aesthetic benefits and gentleness profile into formulations,” Asha Patel Shah, head of skin health and baby medical affairs at Kenvue, said in a statement to The Hill.

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