The short answer: zinc oxide is one of only two sunscreen ingredients the FDA has proposed classifying as "generally recognized as safe and effective." Every other common sunscreen active — including oxybenzone, avobenzone, and octinoxate — is still awaiting that determination.

If you have ever wondered why mineral sunscreen brands emphasize zinc oxide so heavily, the FDA's regulatory position is a big part of the answer. Here is exactly what the agency has said and what it means for the sunscreen you choose.

What Is the FDA's GRASE Standard?

GRASE stands for "generally recognized as safe and effective." It is the benchmark the FDA uses for over-the-counter drug ingredients, which sunscreens are, since they make a drug claim (UV protection). An ingredient must meet the GRASE standard to be sold in the U.S. without a prescription and without going through the full new drug approval process.

For a sunscreen ingredient to earn GRASE status, manufacturers must demonstrate both that it is safe for human use and that it effectively blocks UV radiation at the labeled SPF.

Which Sunscreen Ingredients Are GRASE?

In its proposed order on over-the-counter sunscreens, the FDA concluded that zinc oxide and titanium dioxide meet the GRASE criteria at concentrations up to 25 percent. Those are the only two sunscreen actives that currently hold this classification.

The remaining 12 commonly used chemical UV filters, including oxybenzone, avobenzone, octisalate, octocrylene, homosalate, and octinoxate,  were placed in a category requiring additional safety data before the FDA will classify them. Two ingredients (PABA and trolamine salicylate) were proposed as not GRASE due to safety concerns.

Why Does the FDA Require More Data on Chemical Filters?

The FDA has raised specific concerns about systemic absorption. A 2019 study published in JAMA found that several chemical UV filters: oxybenzone, avobenzone, octocrylene, and ecamsule were absorbed into the bloodstream at concentrations that exceeded the FDA's threshold for waiving toxicology studies. A 2020 follow-up study found similar results for homosalate, octisalate, and octinoxate.

The FDA was clear that absorption alone does not indicate that a substance is harmful, but said the data gap is sufficient to require additional clinical studies before granting GRASE status.

Does This Mean Chemical Sunscreens Are Unsafe?

The FDA has not said chemical sunscreens are dangerous, it has said there is not yet enough data to confirm they meet the same safety standard as zinc oxide. The agency has consistently encouraged people to keep wearing sunscreen while research continues, citing the known risks of UV exposure and skin cancer.

That said, 59 percent of U.S. adults are now concerned about sunscreen ingredients, according to a 2026 Melanoma Research Alliance survey and the FDA's unresolved data requests are part of what is driving that concern.

What Does This Mean for Zinc Oxide Specifically?

Zinc oxide sits on the skin's surface after application. It is not absorbed into the bloodstream. It provides broad-spectrum protection against both UVA and UVB radiation, and it works immediately; no 15- to 20-minute wait is required. These properties, combined with the GRASE proposal, make it the ingredient of choice for people who want regulatory confidence in what they apply to their skin.

Waxhead formulations use non-nano zinc oxide as the sole active ingredient at concentrations that fall within the FDA's proposed GRASE range. The complete ingredient list includes coconut oil, jojoba oil, beeswax, and iron oxides, nothing that requires a chemistry degree to recognize.

The Bottom Line

The FDA's proposed GRASE classification for zinc oxide is the clearest regulatory signal available that a sunscreen ingredient has met a rigorous safety and effectiveness standard. If ingredient transparency matters to you, that distinction is worth knowing.

For a broader look at how zinc oxide compares to chemical filters, see our guide: Is zinc oxide sunscreen actually better than chemical sunscreen?

What Does the FDA Say About Zinc Oxide in Sunscreen?