The US Approved Its First New Sunscreen Filter Since 1999 — What Bemotrizinol Changes About Korean Sunscreens

What the FDA actually did

The mechanism is a final administrative order, OTC000039, amending OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. The notice of its availability was published in the Federal Register on June 10, 2026, and BASF, which markets the ingredient as Tinosorb S, announced the approval days later.

The order adds bemotrizinol at concentrations up to 6 percent to the monograph. In regulatory language, a sunscreen containing it is generally recognized as safe and effective if it meets the monograph's conditions, including a finished-product SPF of not less than 2. Practically, that means a US manufacturer can now use it without filing a new drug application.

It is the first new sunscreen active ingredient the FDA has added since 1999 — a 27-year gap. Bemotrizinol itself is not new chemistry. It has been in EU and Korean products for two decades.

Why the American list was frozen in the first place

In the EU, sunscreen is a cosmetic under Regulation (EC) No 1223/2009, and permitted UV filters are listed in Annex VI. Adding one is a scientific safety assessment followed by an amendment to the annex. In Korea, sunscreens are functional cosmetics regulated by the Ministry of Food and Drug Safety, with permitted UV filters and their maximum concentrations set out in the functional cosmetics standards.

In the US, any product making an SPF claim is an OTC drug. A new active has to go through the monograph process, which is slower and evidentiarily heavier by design. Nothing about that pathway is a judgment on the filters themselves — it is a different legal category with a different burden of proof.

The result is a count gap. Compilations of the three regulators' lists put the US at roughly 17 permitted filters after this addition, the EU at about 29, and Korea at about 32. Exact totals depend on how you count salts and isomers, but the direction is not in dispute.

What is still not available in the US

Bemotrizinol was the most-requested addition, but it is one of several modern filters approved in both Korea and the EU. Still outside the US monograph:

• Bisoctrizole (Tinosorb M) — a hybrid particulate filter covering UVB through UVA1
• Diethylamino hydroxybenzoyl hexyl benzoate (DHHB, Uvinul A Plus) — a photostable UVA1 filter
• Ethylhexyl triazone (Uvinul T 150) — a highly efficient UVB filter
• Terephthalylidene dicamphor sulfonic acid (ecamsule, Mexoryl SX) and drometrizole trisiloxane (Mexoryl XL)
• MCE (Mexoryl 400) — an ultra-long UVA1 filter

This is why a Korean or European formula can often reach high UVA protection with a lighter, less occlusive base. More efficient filters mean less filter mass for the same measured protection, and less filter mass is what a cosmetically elegant texture is usually made of.

Where bemotrizinol absorbs

Bemotrizinol has absorption peaks at approximately 310 nm and 340 nm, which places it across UVB and into UVA2. It is not a standalone UVA1 solution; in formulation it contributes to a system that reaches a critical wavelength above 370 nm when combined with other actives. It is also valued as a photostabiliser for avobenzone, which is the workhorse UVA filter in most American sunscreens and degrades in sunlight without help.

So the realistic near-term effect on US formulas is fewer stabiliser gymnastics and more room in the formula, rather than a jump to filters like DHHB or Tinosorb M.

The UVA label is where the three systems really diverge

Filters are only half the story. How each market tells you about UVA protection differs, and this affects what you can compare on a shelf.

• Korea uses the PA grade, derived from persistent pigment darkening (PPD) measured in vivo per ISO 24442. The bands are PA+ for PPD 2 to 4, PA++ for above 4 to 8, PA+++ for above 8 to 16, and PA++++ for above 16.
• The EU follows Commission Recommendation 2006/647/EC: a product claiming SPF should deliver a UVA protection factor of at least one third of the labelled SPF and a critical wavelength of at least 370 nm. Products meeting it may carry the UVA circle logo.
• The US uses a single pass/fail term — Broad Spectrum — awarded on a critical wavelength of 370 nm or above. There is no graded UVA scale on an American label.

This is why a US SPF 50 and a Korean SPF 50+ PA++++ are not comparable statements. The SPF numbers describe the same thing; the UVA information does not. A PA rating tells you roughly how much UVA protection was measured. "Broad Spectrum" tells you only that a threshold was cleared.

What approval does not mean

Three things are worth separating out, because the headlines blurred them.

First, approval is not availability. A monograph amendment lets manufacturers formulate; it does not put product on shelves. Reformulation, stability testing and SPF testing take time, so the American shelf will look mostly unchanged for a while.

Second, this does not make imported sunscreens legal to sell in the US as SPF products. A Korean sunscreen containing filters still outside the monograph remains outside it, regardless of how well it performs.

Third, none of this changes application. SPF and PA are both measured at 2 mg/cm², and the gap between the tested amount and the amount most people apply remains the single largest variable in real-world protection — far larger than the difference between two filter systems. That is the same reasoning covered in the layering order piece, where sunscreen quantity, not sequence, does most of the work.

How to read a label with this in mind

The practical version is short. Read the actives panel, not the front. If you are buying in Korea or the EU, a PA+++ or PA++++ grade tells you UVA protection was graded rather than just thresholded. If you are buying in the US, Broad Spectrum plus a high SPF is the most the label will tell you, and the filter list is where the rest of the information lives.

And regulatory novelty is not a reason to change a routine that is working. A filter approved in 2026 is not more protective than one approved in 1999 by virtue of being newer; it is differently efficient, differently photostable, and differently textured. Texture matters because it determines whether you apply enough — which is the whole argument. If your current sunscreen stings, pills or feels heavy, that is a real reason to switch, and the constraints on filter choice for reactive skin are discussed in the sensitive skin piece. If your interest is finish rather than protection, how skin reflects light covers what is actually being changed.

The EU's approach to capping actives by concentration, and what that implies for reading any ingredient list, is the same logic set out in the retinol limits piece — regulators set ceilings, and the ceiling is not a recommendation.

Sources and date: US Food and Drug Administration final administrative order OTC000039 amending OTC Monograph M020, Sunscreen Drug Products for Over-the-Counter Human Use, adding bemotrizinol at concentrations up to 6 percent, with the notice of availability published in the Federal Register on June 10, 2026, and the monograph condition of a finished-product SPF of not less than 2; BASF's June 2026 announcement of US approval of Tinosorb S, including the stated absorption peaks near 310 nm and 340 nm and the 1999 date of the previous new US filter approval; Regulation (EC) No 1223/2009 Annex VI for EU permitted UV filters; Commission Recommendation 2006/647/EC for the one-third UVA-PF ratio and the 370 nm critical wavelength; ISO 24442 for in vivo UVA (PPD) determination and the PA banding used in Korea; published comparisons of permitted-filter counts across the US, EU and Korean lists, which vary slightly by counting convention. Verified August 2026. Patch test any new sunscreen on a small area before regular use, and take persistent stinging, burning, rashes or a suspected sun allergy to a dermatologist rather than to a product swap — this article is general and regulatory information, not medical advice.