FDA Sunscreen Update 2026: What Changed and What It Means

The FDA made two sunscreen decisions in 2026. First, it added a new active ingredient, bemotrizinol, to the list of permitted sunscreen filters. Second, it issued a final order removing two old ingredients, PABA and trolamine salicylate. The first change is already in effect. The second takes effect on September 11, 2027. Your current sunscreen is not unsafe because of either one.

Miamibeachbum
Make Sun Care Part of Your Routine
Explore Miamibeachbum’s sun-obsessed body care as you consider what sunscreen labels and FDA updates mean for your routine.

TL;DR

  • On June 9, 2026, the FDA added bemotrizinol to the sunscreen monograph. It is the first new active ingredient in more than 25 years.
  • Bemotrizinol is allowed at up to 6 percent. Products using it may be legally marketed from August 9, 2026, under the conditions of the order.
  • PABA and trolamine salicylate are being removed. That takes effect on September 11, 2027.
  • Bemotrizinol is new to the U.S. shelf, not new to the world. It has been used in Europe and other countries for decades.
  • Your label checks stay the same: broad spectrum, SPF, active ingredients, dosage form.

Table of Contents

What the FDA changed in 2026

The FDA added bemotrizinol to the list of permitted active ingredients in over-the-counter sunscreens. The agency describes it as the first new active sunscreen ingredient added to the monograph since the late 1990s.

The legal vehicle was a final order published in the Federal Register on June 10, 2026. It amends monograph M020, which governs sunscreen drug products. The order is numbered OTC000039.

The FDA links the decision to its stated priority of improving the regulatory process for OTC sunscreen and encouraging innovation. It also says U.S. sunscreen regulation had fallen behind other countries.

What the FDA changed in 2026

Two separate actions, not one

Many headlines blur these together. They are different orders.

Action What it does Timing
Order OTC000039 Adds bemotrizinol as a permitted active ingredient Final order June 2026. Marketing allowed from August 9, 2026
Order OTC000008-1 Removes PABA and trolamine salicylate Final order September 2026. Effective September 11, 2027

The FDA explains the second action in its questions and answers on sunscreen regulatory actions. Its review concluded that the risks of these two ingredients in sunscreen outweigh their benefits. In the FDA’s terms, they are not “generally recognized as safe and effective,” known as GRASE.

What bemotrizinol is

Bemotrizinol is an organic (chemical) UV filter. A JAMA summary of the approval says it protects against both UVA and UVB rays, has low skin absorption, and has been sold in Europe and many other countries for decades.

The ingredient is sold by BASF under the name Tinosorb S, according to BASF’s own announcement. BASF says the approval brings broad-spectrum protection and strong photostability to the U.S. market. That is the supplier’s view, but it matches why sunscreen fans have followed this filter for years.

The rules attached to it

The final administrative order sets conditions:

  • Concentration up to 6 percent, per the Federal Register notice.
  • A minimum SPF of not less than 2 for products containing bemotrizinol. This is a floor for the ingredient, not a target. Real sunscreens aim much higher.
  • Allowed forms: oil, lotion, cream, gel, butter, paste, ointment, stick, and certain non-aerosol or isolated-propellant spray systems.

The spray detail matters if you buy sprays. Not every spray format is covered. For more on spray safety, see our guide to spray sunscreen safety.

When you can buy sunscreen with bemotrizinol

The order allows products with bemotrizinol to be legally marketed from August 9, 2026, subject to its conditions. A reformulated product still has to be made, tested and shipped. Shelves fill slowly.

There is also an exclusivity period. The order gives DSM Nutritional Products, the company that requested the change, 18 months of marketing exclusivity. That clock starts on the date products may lawfully be marketed under the order. Its licensees, assignees or successors share that right. In practice, expect the first products to come from companies tied to that supply chain. Check the FDA order and brand announcements for who is selling now.

Why Europe had this filter first

A common question is why European sunscreens seemed ahead. The short answer is process. The FDA itself says U.S. sunscreen regulation had fallen behind other countries.

The U.S. handles sunscreen as an over-the-counter drug. The route for changing the rules is the monograph system. Under the CARES Act, the FDA can change an OTC monograph by administrative order instead of the older rulemaking route. Products that meet monograph requirements can reach the market without an individual approved drug application, as the FDA explains.

The SAFE Sunscreen Standards Act was signed into law in November 2025, according to a March 2026 report on new formulas. We do not cite that law for any detail here beyond its existence and timing. Read the text itself if you need its provisions.

What PABA and trolamine salicylate removal means for you

If you have never heard of PABA, that is a good sign. It is an old ingredient that few current U.S. sunscreens use. The FDA’s final order means these two ingredients can no longer be part of an OTC sunscreen once the effective date of September 11, 2027 arrives.

What you should do:

  1. Read the Drug Facts panel on any sunscreen you own. Active ingredients are listed at the top.
  2. If you see PABA or trolamine salicylate, plan to switch. You have until the effective date, but there is no reason to wait.
  3. If you see other filters or minerals, nothing about this order applies to you.

How to read a sunscreen label after the update

Nothing about the basics has changed. These checks work today and will work after bemotrizinol products arrive.

Broad spectrum

This means protection against UVA and UVB. Skip any product without it. Bemotrizinol covers both, but a label claim is what tells you the finished product was tested.

SPF number

The floor of SPF 2 in the order is a technical minimum. For daily outdoor use, pick a real level. Our guide to SPF 30 vs 50 explains the difference.

Active ingredients

The Drug Facts panel names them. Mineral sunscreens list zinc oxide or titanium dioxide. Chemical sunscreens list organic filters. Bemotrizinol will appear in the second group. Not sure which suits you? Read chemical vs. mineral sunscreen.

Dosage form

The order lists the forms allowed for bemotrizinol. A lotion, cream, stick or gel is the simplest fit. Sprays are covered only for certain systems.

Lot code and expiration

Sunscreen is a drug and has an expiration. Our walkthrough of 2026 FDA sunscreen rules shows how to check SPF, broad spectrum and lot codes.

Perspective: why the new filter does not change our approach

We formulate for people who spend their days outside and who often have breakout-prone or sensitive skin. Our products are formulated by a marine scientist. They are reef-safe, vegan and cruelty-free, and made without petroleum.

The FDA news is good for the category. More options and clearer rules help everyone. We welcome any step that makes U.S. sunscreen better.

Perspective: why the new filter does not change our approach

But a new ingredient is not a reason to drop good habits. A sunscreen only works if you apply enough, reapply, and like wearing it. Skin that breaks out needs a formula it can tolerate. That is why we keep our focus on mineral sunscreen sprays, body care that clears body breakouts, and simple routines.

Our advice: do not chase the newest filter. Check the label, pick a broad spectrum SPF you will use every day, and read the active ingredients. If a new product with bemotrizinol suits your skin, that is a fair choice. If a mineral formula suits it better, that is fair too.

— Ayssa

Shop sun and body care that fits the new rules

If you want a mineral option today, look at Blocked SPF50. For the rest of the routine, browse our Bodycare collection for creams that target body breakouts, or the Outdoor collection for botanical bug repellents and leave-in beach hair conditioners.

Blocked SPF50

Every product is reef-safe and made with ethically sourced plant ingredients. Always read the label and follow the directions on the pack.

What to expect next

Expect a gradual change rather than a sudden one.

  • New products with bemotrizinol appear first from brands that can source it and finish testing.
  • Exclusivity may limit how many brands launch early. The order’s 18 months run from the date marketing became lawful under it.
  • Some people will prefer the feel of these formulas. Others will stay with minerals.
  • The September 11, 2027 date will push any remaining PABA or trolamine salicylate products off the market.

For current details, use the FDA’s own pages. The agency’s sunscreen questions and answers page is the place to look for updates.

A note on special situations

If you have a skin condition, a history of skin cancer, or a reaction to sunscreen, ask a dermatologist before changing products. If you are choosing a sunscreen for a baby under six months, ask a pediatrician. Sun avoidance and shade are the usual guidance for that age.

FAQ

What is the name of the new sunscreen ingredient the FDA approved?

It is bemotrizinol. The FDA added it to the OTC sunscreen monograph in a final order in June 2026. BASF sells it as Tinosorb S.

Is the FDA banning any sunscreen ingredients in 2026?

Yes, two. The FDA issued a final order removing PABA and trolamine salicylate, effective September 11, 2027. The agency concluded that their risks outweigh their benefits in sunscreen. This is separate from the bemotrizinol decision.

Can I buy sunscreen with bemotrizinol now?

It may be legally marketed from August 9, 2026, under the order’s conditions. Whether a specific product is on shelves depends on the brand. Check the Drug Facts panel for bemotrizinol in the active ingredients.

Why does Europe have different sunscreen ingredients than the U.S.?

The FDA says U.S. regulation had fallen behind other countries. Sunscreen is regulated as a drug here, and changes to the monograph took years. Bemotrizinol has been used in Europe and elsewhere for decades.

Do I need to throw out my current sunscreen?

Not because of this news. Check the label for PABA or trolamine salicylate, and check the expiration date. If neither is a problem, you can keep using it as directed.

Sources

en FDA sunscreen update 2026

← Older Post