New sunscreen ingredient wins FDA approval after years of delay

## The FDA Just Approved a New Sunscreen Ingredient — 21 Years After It Was First Requested

The Food and Drug Administration has approved the first new sunscreen ingredient for the U.S. market in more than 25 years. The ingredient, bemotrizinol, has been available in Europe since 1999, in Japan, and in South Korea for years. Americans have been buying it when they travel abroad because it works better and feels better than what's available at home.

The approval announced Tuesday is a milestone for U.S. consumers. It's also a case study in how regulatory delays can leave an entire population using outdated products for decades.

### What Makes Bemotrizinol Different

Current U.S. sunscreen options fall into two categories, each with significant drawbacks. Chemical-blocking ingredients protect against either UVA or UVB rays, but not both — companies have to mix multiple chemicals to achieve "broad spectrum protection." Mineral-based ingredients like zinc oxide block both types of UV rays, but they leave a chalky white residue on the skin that makes them cosmetically unappealing, especially for people with darker skin tones.

Bemotrizinol solves both problems. It protects against both UVA and UVB rays in a single ingredient, and it goes on clear. No white streaks. No mixing multiple chemicals. No choosing between protection and appearance.

"For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward," said David Andrews of the Environmental Working Group, which has long pushed the FDA to both tighten sunscreen standards and allow new ingredients. "The approval of bemotrizinol will help change that."

The FDA confirmed that bemotrizinol is safe for adults and children 6 months and older, causes little skin irritation, and shows minimal absorption into the body — addressing the safety concerns that have slowed previous approvals.

### How This Happened — 21 Years of Bureaucratic Gridlock

The timeline tells the story. Bemotrizinol was authorized by European authorities in 1999. DSM Nutritional Products, the Dutch manufacturer, first filed for FDA review in 2005. That's 21 years from first filing to approval.

The delay wasn't because the ingredient was dangerous. Europe, Japan, South Korea, and dozens of other countries had already deemed it safe based on extensive data. The delay was because the FDA's system for updating its list of approved over-the-counter drug ingredients was, by the agency's own acknowledgment, fundamentally broken.

The FDA's sunscreen monograph — the regulatory framework that governs which ingredients can be used — hadn't been meaningfully updated since the 1990s. The agency would request new studies, companies would conduct them, the FDA would request additional studies, and the cycle would repeat without resolution.

DSM began a new round of studies requested by the FDA in 2019. The decision still didn't come until 2026.

Congress finally intervened in 2020, authorizing a streamlined process for reviewing sunscreen ingredients. Bemotrizinol is the first ingredient to go through that expedited pathway. The fact that it still took six more years after the streamlined process was created tells you how slow the system was to begin with.

### The Market Impact

Bemotrizinol will initially be sold in the U.S. by DSM under the brand name Parsol Shield, expected to launch later this year. After an 18-month exclusivity period, other manufacturers will be able to use the ingredient, which is when consumers will see it appear across a range of sunscreen brands at different price points.

The approval has implications beyond one ingredient. The FDA has been gradually updating its sunscreen standards — banning misleading terms like "waterproof" in 2011, requiring broad-spectrum protection that same year, and proposing additional measures in 2021 including caps on SPF numbers and stronger UVA protection requirements. Those 2021 proposals still haven't been finalized.

Health and Human Services Secretary Robert F. Kennedy praised the bemotrizinol approval for "advancing innovation" and increasing competition. It's a notable statement from an HHS secretary whose department oversees an agency that spent two decades preventing exactly that innovation from reaching consumers.

### What's Still Missing

Bemotrizinol is a step forward, but it's one ingredient in a category where the U.S. still lags behind Europe and Asia. Several other sunscreen ingredients available abroad remain stuck in the FDA's review pipeline. The 2021 proposed rules on SPF caps and UVA protection standards remain unfinished.

The underlying problem — a regulatory system designed for a slower era that cannot keep pace with product development — hasn't been fixed. The 2020 streamlined process helped this time, but the FDA's capacity to review and approve new sunscreen ingredients remains far below what consumers need.

Skin cancer remains the most common cancer in the United States, with approximately 5.4 million cases diagnosed annually. Better sunscreen ingredients directly reduce that burden. Every year of delay has a measurable cost in preventable disease.

### What This Means For You

Starting late this year, you'll see "Parsol Shield" appear on sunscreen labels. It's worth looking for. A single ingredient that blocks both UVA and UVB without white residue is genuinely better than what's currently on U.S. shelves.

But the bigger takeaway is this: the products you use every day are shaped as much by regulatory bureaucracy as by science. The rest of the world has had access to this ingredient since 1999. American consumers waited 27 years — not because scientists disagreed about its safety, but because a government agency couldn't update its own rules in a reasonable timeframe.

When you're choosing a sunscreen, remember that "FDA-approved" doesn't mean "the best available." It means "the best that survived the process." Sometimes those are the same thing. Sometimes, as with sunscreen for the last 25 years, they are very different things.