The FDA Has Confirmed Two Sunscreen Actives Safe. Here Is What That Means.

The FDA has reviewed 16 sunscreen active ingredients and confirmed only two are generally recognized as safe and effective (GRASE): zinc oxide and titanium dioxide. The remaining 14 — including avobenzone, oxybenzone, and octinoxate — are not confirmed unsafe, but the FDA has determined there is insufficient data to classify them as GRASE. That data gap is why only two actives have full regulatory approval after decades of review.

There are sixteen sunscreen active ingredients that have been reviewed under the FDA's OTC Drug Monograph. Of those sixteen, two have received the FDA's full confirmation that they are generally recognized as safe and effective. Zinc oxide is one of them.

The GRASE designation sounds simple. It is actually the result of decades of safety review, toxicological data, and regulatory process. This post explains what GRASE means, how it is earned, and why only two actives have received it out of sixteen reviewed.

What GRASE Actually Means

GRASE stands for generally recognized as safe and effective. It is the FDA's highest classification for an OTC drug ingredient, meaning the ingredient has been evaluated through the regulatory process and the FDA has determined that qualified experts would agree, based on available scientific evidence, that it is safe and effective for its labeled use.

For sunscreen actives, GRASE status means the FDA has reviewed the safety and effectiveness data and confirmed that the active can be used in OTC sunscreen products. It does not mean the ingredient is perfect or risk-free in all scenarios. It means the safety question has been answered to the FDA's standard.

The formal GRASE determination for zinc oxide and titanium dioxide is documented in FDA Final Administrative Order OTC000006 (Sunscreen Drug Products For Over The Cou), finalized in 2021 following decades of regulatory review.

How the Sixteen Actives Break Down

Under the FDA monograph, sunscreen actives fall into three categories.

Category I: GRASE. The active has sufficient safety and effectiveness data. Two actives: zinc oxide and titanium dioxide.

Category II: Not GRASE. The active is not permitted for use. Two actives: aminobenzoic acid (PABA) and trolamine salicylate.

Category III: Insufficient data. The FDA cannot determine GRASE status because the required safety data has not been submitted. Twelve actives fall here, including oxybenzone, avobenzone, octinoxate, homosalate, octisalate, and octocrylene, among others.

The twelve Category III actives are still legally permitted for sale. Category III means the FDA cannot confirm them as safe and effective, not that they have been found unsafe. But the distinction between a confirmed GRASE determination and an unresolved regulatory status is real and worth understanding.

Why Zinc Oxide and Not Titanium Dioxide?

Both zinc oxide and titanium dioxide are GRASE. Both are mineral actives. But there is a meaningful functional difference.

Titanium dioxide provides strong UVB protection but its UVA coverage is limited. It absorbs well in the UVB range and at the shorter end of the UVA spectrum, but coverage drops off significantly in the longer UVA wavelengths, particularly UVA I, which penetrates deepest into the skin.

Zinc oxide covers the full UV spectrum. It is the only single mineral active that provides meaningful protection across both UVA and UVB without requiring a secondary active. At 21% concentration, it delivers that coverage from one ingredient.

Titanium dioxide is GRASE and is used in many mineral formulas alongside zinc oxide. Running zinc oxide alone at high concentration is a formulation choice that simplifies the active ingredient profile to a single confirmed-GRASE mineral filter.

The History of the Safety Review

The FDA has been reviewing sunscreen active ingredients since the 1970s. The monograph process for sunscreens formally began in 1978 and has been updated through proposed rules, final monographs, and administrative orders over five decades.

In 2019, the FDA published a proposed rule that represented the first major update to the sunscreen monograph framework in decades. It formally established the three-category system, confirmed zinc oxide and titanium dioxide as GRASE Category I, identified PABA and trolamine salicylate as Category II, and placed twelve actives in Category III pending additional safety data.

The industry consortium representing chemical sunscreen manufacturers pushed back on the required testing, arguing that the proposed tests were too burdensome and unnecessary. As of the finalization of OTC000006 in 2021, the required data for Category III actives had not been submitted. The FDA's position has not changed.

What GRASE Means for Daily Use

If you apply sunscreen every day, the regulatory status of your active ingredient matters more than it does for occasional use. Daily application means daily systemic exposure to whatever the active does in the body.

Zinc oxide as a non-nano mineral active does not absorb through the skin into the bloodstream in any meaningful way. It sits on the skin surface, does its job by reflecting and scattering UV radiation, and does not enter systemic circulation. The GRASE designation reflects decades of evidence supporting that picture.

Chemical actives in Category III have been detected in blood, urine, and breast milk after standard application. The FDA's concern is not that these actives are definitely harmful. The concern is that systemic absorption at those levels has not been evaluated against the kind of safety data the FDA requires. That is an open question, not a closed one.

The Bemotrizinol Update

The FDA issued a proposed administrative order in December 2025 to add Bemotrizinol, also called BEMT, to the sunscreen monograph as a potentially GRASE active. If approved, it would be the first new sunscreen active added to the US monograph since 1999. The proposed order is available through the FDA's regulatory docket (Over Counter Otc Sunscreens) and public comment closed in January 2026.

Bemotrizinol has been used in European and Asian sunscreens for years. If it receives GRASE designation in the United States, it would expand the confirmed-safe active list from two to three. For now, zinc oxide and titanium dioxide remain the only GRASE-confirmed sunscreen actives in the US market.

Reading the Label with This Framework

The active ingredients section of any sunscreen sold in the United States tells you exactly what you are getting. If the active list says zinc oxide, you are looking at a GRASE Category I mineral filter with a fully confirmed safety profile. If the list includes oxybenzone, avobenzone, or any of the other Category III actives, you are looking at actives the FDA has flagged for additional safety review.

This is not a reason to panic about chemical sunscreens. Wearing sunscreen of any kind is better than wearing no sunscreen. But for people who want their daily active to come with a fully resolved regulatory picture, zinc oxide is the one that delivers that.

Swellies uses non-nano zinc oxide as the only active. GRASE Category I. The FDA has deemed two sunscreen actives safe and effective. Zinc oxide is one of them. That is what is in Swellies.

Frequently Asked Questions

What does GRASE mean for sunscreen?

GRASE stands for "generally recognized as safe and effective." It's the FDA's designation for ingredients with enough safety and efficacy data — from published studies and expert consensus — to be approved for over-the-counter use without additional testing requirements.

Which sunscreen ingredients are FDA approved as GRASE?

Only two: zinc oxide and titanium dioxide. The FDA has reviewed 16 actives total. The other 14 lack sufficient data to earn the GRASE designation, which is why the FDA requested more safety studies in 2019 and 2021.

Does "not GRASE" mean an ingredient is unsafe?

No. The FDA's position on non-GRASE actives is that there is insufficient data — not that the ingredient is harmful. The correct framing is "insufficient data," not "unsafe." But GRASE means the data exists and has been reviewed. That distinction matters.

Why did it take so long to evaluate sunscreen ingredients?

Many sunscreen actives were grandfathered into the market before the modern OTC Drug Monograph process existed. The FDA has been working through formal safety reviews since the 1970s, and the final monograph rule wasn't fully updated until 2021.

Is zinc oxide safer than chemical sunscreen actives?

The FDA has deemed zinc oxide safe and effective — that's a regulatory fact. The FDA has deemed two sunscreen actives safe and effective. Zinc oxide is one of them. That's what's in Swellies.

Swellies is a 5-ingredient mineral sunscreen — SPF 46, broad spectrum, no white cast, no grease. See what's in it.