What's Actually In Your Sunscreen

In 2019 and again in 2020, FDA researchers ran a study and published it in JAMA. They had volunteers apply sunscreen the way the label tells you to — the full amount, four times a day — and then measured their blood.

Six common UV filters showed up in plasma: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate. All six exceeded the threshold FDA uses to decide whether an ingredient needs further safety testing. Some were still detectable days after the last application.

FDA was careful about what this means, and so are we: absorption is not the same as harm. Finding a molecule in blood tells you it got there. It doesn't tell you it did anything. We're not going to pretend otherwise.

But it does raise a question, and the question is the point of this page: these ingredients have been on the market for decades, and nobody had measured until 2019.

Two Approved. Two Rejected. Twelve Unknown.

In February 2019, FDA proposed sorting the active ingredients allowed in American sunscreen into three groups.

 

Generally recognized as safe and effective — 2 ingredients. Zinc oxide and titanium dioxide.

Not generally recognized as safe and effective — 2 ingredients. PABA and trolamine salicylate. Both had already left the market.

Insufficient data to decide — 12 ingredients. Cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.

 

Read that last category again, because the wording matters. FDA did not say those twelve are dangerous. It said there isn't enough data to say either way, and asked industry to produce it.

That was 2019. The request is still open.

Those twelve ingredients are in most of the sunscreen on the shelf at your drugstore right now.

What Other Regulators Have Done

 

We're a small company with opinions. Regulators are large institutions that move slowly and document everything. So rather than tell you what we think, here's what they've done.

• Hawaii passed Act 104 in 2018, restricting the sale of sunscreens containing oxybenzone and octinoxate. It took effect January 1, 2021. Key West, the U.S. Virgin Islands, and Palau have passed similar measures. The stated concern was coral reefs.
• The European Union has repeatedly lowered its permitted concentrations for oxybenzone, and restricted homosalate in facial products, following scientific committee opinions that flagged potential endocrine activity.
• California lists benzophenone under Proposition 65. Published research has found benzophenone forming in octocrylene-containing sunscreens as they age on the shelf. Benzophenone is classified as possibly carcinogenic to humans — not known, and we're not going to upgrade it for effect.

None of this proves harm. All of it is a matter of public record, and all of it happened because somebody with more resources than us looked closely and got uncomfortable.

The Ingredient That Isn't Regulated At All

 

Here's the part almost nobody knows about.

Butyloctyl salicylate is not an approved UV filter in the United States. It's classified as a skin conditioning agent and film former. It also absorbs ultraviolet light.

Because it isn't an active ingredient, it isn't counted toward active-ingredient limits, and it doesn't appear in the Drug Facts panel. It shows up in the inactive list, further down, where nobody reads. It can contribute to a product's measured SPF without ever passing through the framework built to evaluate ingredients that contribute to SPF.

We're not going to tell you it's dangerous. We don't know that. Nobody does — that's precisely the issue. What we'll say is that an ingredient doing an active's job while sitting outside the active's rulebook is a gap worth understanding before you rub it on your kid.

We left it out.

Why the American Sunscreen Aisle Is So Short

If you've bought sunscreen in Europe or Australia and thought it felt better, you weren't imagining it. They have filters we don't — modern ones, developed in the last thirty years, that go on clear and hold up in sunlight.

No new UV filter has been added to the U.S. monograph since the 1990s. Several have been pending at FDA for more than a decade.

This isn't a conspiracy. It's a process that's been stuck. Sunscreens are regulated as over-the-counter drugs in the U.S., which means a new filter needs a drug-grade evidence package — and the approval pathway has been rewritten twice, by the Sunscreen Innovation Act in 2014 and again by the CARES Act in 2020, without producing a new approved filter either time.

The mineral actives have their own ceiling: zinc oxide is capped at 25%. That's a real constraint on how much SPF you can get from zinc alone, and it's part of why some formulas reach for help elsewhere.

What We Made Instead

Mineral 45 uses zinc oxide — one of the two actives FDA proposed as generally recognized as safe and effective. It's made for us by our FDA-registered partner and manufacturer under our own labeler code, and it's tested for broad-spectrum protection.

You won't find these in it:

• Oxybenzone
• Octinoxate
• Avobenzone
• Octisalate
• Homosalate
• Octocrylene
• Butyloctyl salicylate

Two Things We Won't Tell You

We won't tell you chemical sunscreens will hurt you. The evidence isn't there. Twelve ingredients sitting in a data gap is a real thing worth knowing about, and it is not the same as proof of harm. A brand that blurs that line to sell you something is exactly what we started this company to get away from.

And we won't tell you to skip sunscreen. Whatever you make of everything above, unprotected sun exposure is the risk we actually understand well. Wear sunscreen. If you read this page and go buy someone else's mineral sunscreen, we'll count that as a good outcome.

We'd just rather you chose it knowing what's in it.

We'll keep digging into this.

 

xoxo, Marisa