The FDA hasn't approved a new sunscreen ingredient since 1999, but a proposed rule change could dramatically reshape what's available on store shelves. In 2019, the agency proposed new sunscreen regulations that would eliminate approval for most of the 16 currently FDA-approved sun protection ingredients, leaving only two mineral options: zinc oxide and titanium dioxide . The agency cited "significant gaps" in safety evidence for the other ingredients, though their approvals remain in place for now .

What's Driving the FDA's Proposed Sunscreen Overhaul?

The FDA's proposed rule represents a significant shift in how the agency evaluates sunscreen safety. Currently, 16 sun protection ingredients have FDA approval, split between mineral and chemical filters . However, the agency's 2019 proposal would pull approvals for most chemical sunscreen ingredients, citing insufficient evidence of long-term safety . This move reflects growing scrutiny around how much chemical sunscreen actually absorbs into the body and whether that absorption poses health risks.

The two mineral ingredients that would remain approved, zinc oxide and titanium dioxide, work differently than chemical filters.

"Mineral sunscreens are physical blockers and reflect UV rays off the skin," explained Susan Massick, MD, a dermatologist at The Ohio State University Wexner Medical Center.

Susan Massick, MD, Dermatologist at The Ohio State University Wexner Medical Center

In contrast, chemical sunscreens absorb UV light and convert it to heat, which is why they tend to be more cosmetically appealing and easier to apply .

Are Chemical Sunscreens Actually Unsafe?

Despite the FDA's proposed restrictions, dermatologists emphasize that both mineral and chemical sunscreens are currently considered safe when used as directed.

"Both mineral- and chemical-based sunscreens are safe," stated Susan Massick, MD.

Susan Massick, MD, Dermatologist at The Ohio State University Wexner Medical Center

However, the FDA's concern centers on the lack of comprehensive safety data for chemical ingredients, particularly regarding systemic absorption, meaning how much of the ingredient enters the bloodstream .

The distinction matters because chemical sunscreen ingredients like avobenzone, cinoxate, and dioxybenzone are designed to be absorbed by the skin to work effectively. This absorption mechanism is fundamentally different from mineral filters, which sit on top of the skin and reflect rays without penetrating . The FDA's proposed rule suggests that the agency wants more rigorous testing before continuing to approve chemical ingredients for widespread use.

How to Choose a Sunscreen While Regulations Evolve

• Look for Broad-Spectrum Protection: Choose sunscreens labeled "broad-spectrum," which protect against both UVA and UVB rays. Research shows that broad-spectrum sunscreen use lowers the risk of increased signs of aging, like fine lines, sagging, and hyperpigmentation, by 24 percent .
• Use SPF 15 Minimum: Studies have found that sunscreen with a minimum SPF of 15 can lower the risk of developing squamous cell carcinoma by 40 percent and melanoma by 50 percent .
• Understand Mineral vs. Chemical Trade-offs: Mineral sunscreens tend to be thicker and may be harder to rub in, but they're gentler on sensitive skin and less likely to cause irritation. Chemical sunscreens are more cosmetically appealing but involve systemic absorption .
• Verify FDA Approval: All sunscreen ingredients sold over-the-counter in the United States are approved and regulated by the FDA, meaning you know you're getting tested protection when you buy from established brands .
• Avoid DIY Sunscreen: Despite viral TikTok videos promoting homemade sunscreen recipes, experts strongly advise against DIY formulations because they lack the rigorous testing and quality control that FDA-approved products undergo .

The mineral sunscreen ingredients that would remain approved under the FDA's proposed rule are zinc oxide and titanium dioxide. Zinc oxide blocks both UVA and UVB rays effectively, while titanium dioxide protects against both but doesn't block the full spectrum of UVA rays as effectively as zinc oxide . Both are naturally occurring minerals that sit on the skin's surface rather than being absorbed into the bloodstream.

What About the Other Chemical Ingredients Currently on Shelves?

Chemical sunscreen ingredients currently approved by the FDA include avobenzone, cinoxate, dioxybenzone, and ensulizole, among others . Avobenzone is considered the best form of protection against UVA rays but is less protective against UVB rays . Cinoxate blocks UVB rays, while dioxybenzone, a derivative of benzophenone, blocks UVB rays and some UVA rays . These ingredients remain available today, but their future approval status depends on whether the FDA's proposed rule is finalized and what additional safety data emerges.

"Sunscreen is one of the most important things you can put on your skin," said Ife J. Rodney, MD, founding director of Eternal Dermatology and Aesthetics in Fulton, Maryland.

Ife J. Rodney, MD, Founding Director of Eternal Dermatology and Aesthetics

The evidence supporting sunscreen use is compelling. Research has demonstrated that regular sunscreen use significantly reduces skin cancer risk and slows visible signs of aging, making the choice of which type to use an important health decision.

The FDA's regulatory process for sunscreen is notably rigorous compared to other topical skincare products. Because sunscreen is classified as a drug rather than a cosmetic, it must undergo clinical trials and testing to verify that the product's contents match its label claims . For example, products claiming to be water-resistant must demonstrate that they maintain their SPF protection when exposed to water . This level of oversight explains why the FDA hasn't approved new sunscreen ingredients since 1999, though the agency announced in December that it is poised to approve a new ingredient called bemotrizinol .

As the FDA continues to evaluate sunscreen safety and potentially finalize its proposed rule, consumers can feel confident that any sunscreen purchased over-the-counter in the United States has met strict safety and effectiveness standards. Whether you choose a mineral or chemical formulation, the most important step is using sunscreen consistently with an SPF of at least 15 and reapplying as directed, especially after swimming or sweating.