The U.S. Food and Drug Administration (FDA) has approved the first new sunscreen active ingredient in over two decades, ending a regulatory stalemate that left American consumers with fewer options than nearly every other developed nation. The agency cleared menthyl anthranilate—a filter already widely used in Europe, Canada, and Asia—as part of a broader push to modernize sunscreen regulations. The decision, announced this month, marks a turning point for an industry frustrated by decades of delays, but also raises questions about why the U.S. lagged so far behind global standards.
For years, American sunscreen manufacturers have operated with a limited palette of six FDA-approved active ingredients, a list that hasn’t been updated since 2002. Meanwhile, countries like Australia, Japan, and the European Union have approved dozens of additional filters, including bisabolene and trilene, offering consumers broader UV protection and more sensitive-skin formulations. The FDA’s approval of menthyl anthranilate—paired with two other new filters, bisabolene and trilene—is the first step toward bridging that gap, but experts warn the process will remain slow.
“This is a significant milestone, but it’s just the beginning,” said Dr. Susan Weinkle, president of the Skin Cancer Foundation. “The FDA’s review process is notoriously cumbersome, and we still have no timeline for when other widely used international filters—like tinosorb S—will be approved.” The delay has left U.S. consumers with fewer high-performance options, particularly for sensitive skin or those seeking broad-spectrum protection against both UVA and UVB rays.
Why Did It Take So Long for the FDA to Approve New Sunscreen Filters?
The FDA’s sunscreen approval process has long been criticized as outdated and bureaucratic. Unlike the European Medicines Agency (EMA) or Health Canada, which use a premarket approval system for cosmetic ingredients, the FDA treats sunscreen as a drug, subjecting it to stricter safety and efficacy standards. The agency’s last major sunscreen review, completed in 2019, identified 12 new active ingredients for potential approval—but only three have been cleared so far.
Industry insiders attribute the delays to a combination of regulatory inertia and scientific scrutiny. “The FDA’s process is risk-averse by design,” explained Dr. Henry Lim, chair of dermatology at Henry Ford Health. “They require decades of global safety data, which many newer filters simply don’t have—even if they’ve been used safely in Europe for years.” The agency has also faced criticism for failing to update its monograph system, which governs sunscreen regulations, despite repeated calls from public health groups.
In contrast, the EMA approved 15 new UV filters between 2010 and 2023, allowing EU manufacturers to offer products with higher SPF ratings and better water resistance. The U.S. lags even behind Canada, which approved menthyl anthranilate in 2018—five years before the FDA’s decision.
What Does the FDA’s Approval Mean for Consumers?
For American shoppers, the approval of menthyl anthranilate and the two other new filters (bisabolene and trilene) means expanded options—but not immediately. Sunscreen manufacturers must now submit new drug applications (NDAs) to incorporate the ingredients into their products, a process that can take 12–24 months. The first sunscreens containing these filters are unlikely to hit shelves before 2025.
Menthyl anthranilate, in particular, is expected to benefit consumers with sensitive skin. Unlike chemical filters that can cause irritation, menthyl anthranilate is derived from natural sources and has been used in European sunscreens for over a decade. “This is a game-changer for people who react to oxybenzone or avobenzene,” said Dr. Rachel Nazarian, a dermatologist at Mount Sinai Hospital. “It’s also more stable under sunlight, so it won’t degrade as quickly as some older ingredients.”
However, the approval does not address broader concerns about sunscreen safety. The FDA has yet to ban oxybenzone, a common chemical filter linked to hormone disruption, despite petitions from environmental groups and state bans in Hawaii, Key West, and other regions. The agency also has not updated its broad-spectrum requirement, which currently only applies to UVB protection, not UVA.
How Does the U.S. Compare to Global Sunscreen Standards?
A side-by-side comparison reveals just how far behind the U.S. has fallen in sunscreen innovation. While American consumers have relied on six active ingredients since 2002, other countries have approved dozens more, leading to products with higher SPF ratings, better water resistance, and gentler formulations for sensitive skin.
| Region | Approved Active Ingredients (2024) | Key Innovations | Regulatory Process |
|---|---|---|---|
| United States | 9 (6 since 2002, 3 new in 2024) | Limited high-SPF options; no UVA-only filters | Drug-like approval (NDA required) |
| European Union | 28+ (including tinosorb S, bisabolene) | Higher SPF caps (SPF 50+); more sensitive-skin options | Cosmetic approval (faster than FDA) |
| Australia | 14+ (including trilene, ensulizole) | Mandatory UVA protection labeling; reef-safe options | Therapeutic Goods Administration (TGA) review |
| Japan | 25+ (including octinoxate alternatives) | High UV index adaptations; water-resistant formulas | Pharmaceuticals and Medical Devices Agency (PMDA) |
The table above highlights the regulatory divergence. While the FDA’s approval of menthyl anthranilate is a step forward, it does little to close the gap with global standards. “The U.S. is playing catch-up, and consumers are paying the price,” said Dr. Jane Houlihan, senior vice president of research at the Environmental Working Group (EWG). “Other countries have been updating their sunscreen rules for years—why should Americans have to wait decades for basic protections?”
What Happens Next? The FDA’s Sunscreen Roadmap
The FDA has indicated that more sunscreen filters are in the pipeline, but the timeline remains uncertain. In a statement released this month, the agency confirmed it is reviewing nine additional ingredients, including tinosorb S and tinosorb M, which are widely used in Europe. However, the agency has not set a deadline for decisions.
Public health advocates are pushing for faster action. The Skin Cancer Foundation and American Academy of Dermatology (AAD) have both urged the FDA to expedite reviews, citing rising skin cancer rates and the need for better UV protection. Meanwhile, Congress has introduced bills to streamline the approval process, though none have advanced.
The next major checkpoint is the FDA’s public meeting on sunscreen innovation, scheduled for October 15, 2024. The agency will hear from industry experts, dermatologists, and consumer groups to discuss future regulatory steps. Until then, American consumers will continue to rely on older ingredients—while the rest of the world moves forward.
Key Takeaways: What You Need to Know
- First new filter in 22 years: The FDA approved menthyl anthranilate, bisabolene, and trilene, but products won’t arrive until 2025.
- Global gap remains: The U.S. has 9 approved filters; the EU has 28+. America lags behind Australia, Canada, and Japan in sunscreen innovation.
- Sensitive skin relief: Menthyl anthranilate is gentler than oxybenzone and avobenzene, offering hope for allergy sufferers.
- No oxybenzone ban: The FDA has not addressed concerns about hormone-disrupting chemicals like oxybenzone.
- Next steps: The FDA will review nine more filters, but no timeline is set. A public meeting is scheduled for October 15, 2024.
Have questions about how this approval affects your sunscreen choices? Or concerns about the FDA’s regulatory delays? Share your thoughts in the comments below—or tag @FDA to ask for updates on future filters.