The FDA Has Removed Sunscreen Actives From Its List for the First Time

What was decided?

On 10 September the FDA issued final administrative order OTC000008-1, removing PABA and trolamine salicylate from OTC monograph M020. This final order finalizes the determination made in a 2021 proposed order that the two ingredients are not GRASE. The FDA concluded that the risks of using them as sunscreen active ingredients outweigh the benefits.

The stated grounds are primarily safety. For PABA, the agency pointed to significant rates of allergic and photoallergic skin reactions, including severe cases, and to a risk of cross-sensitization with structurally similar substances such as sulfonamide antibiotics, thiazide diuretics, certain local anesthetics and commonly used dyes.

The effective date is 11 September 2027. The order takes effect on that date unless it is disputed through the applicable statutory process. After that, a product using these substances as sunscreen actives cannot be marketed in the U.S. through the monograph route, and continuing to use them would require an approved new drug application (NDA). Put differently, any formula using them as an active has to be reformulated or withdrawn before then.

That said, this is not a situation where products are about to be pulled from shelves. The FDA said it is not aware of any sunscreen drug products currently marketed in the United States that contain PABA or trolamine salicylate. Neither substance is commonly used in U.S. sunscreen formulas today. So the decision reads more accurately as a step in tidying up the list itself, part of ongoing regulatory modernization, than as an action aimed at particular products.

1. In the same year, one ingredient came in and two went out

In June 2026 the FDA added bemotrizinol as a new active in the OTC sunscreen monograph through final order OTC000039. In September it removed two substances from the same monograph. Addition and removal happened within a single year.

What matters in practice is not the direction but the nature of the list. What this confirms is that the U.S. list of sunscreen actives is not a fixed table where an entry, once added, stays forever, but a living list that substances enter and leave as the evidence changes. In a period of additions only, 'compliant now' also meant 'compliant later'. That no longer holds.

So the way regulatory compliance is recorded has to change too. When you write in a document that your formula conforms to the U.S. monograph, record the date on which that judgment was made. A compliance finding with no date becomes a sentence nobody can verify once time has passed.

• Have you gathered the actives and their concentrations for U.S.-bound sun care into one file?
• Does your compliance review record the date of the judgment?
• Have you assigned an owner and a cadence for checking monograph changes?

2. The year of lead time is not time to reformulate

About a year separates the order's issuance from its effective date. Treating that period as reformulation time will throw the schedule off. A sun care formula is structured so that changing a single active pulls SPF, photostability, sensory experience and stability testing back in with it, and a year is not generous.

For this particular order, most brands are unlikely to need any reformulation at all, since the FDA itself said it is not aware of products using these ingredients. So this year is not time to change a formula; it is time to confirm that your product does not fall within scope, and to leave a record of that confirmation.

What has to be checked is more than the finished-product ingredient list. You have to go down to the composition data for compound raw materials received from suppliers. Even if you never added the substance as an active, whether it is present inside a raw material serving another purpose is worth confirming separately.

If you produce through OEM or ODM, it is better to settle where responsibility for this check sits at the contract or specification stage. When the party holding the formula and the party responsible for labeling are different, the question becomes where news of a regulatory change stops.

3. Note that the reason for removal was allergy

The grounds put forward in this decision were not filtering performance but skin reactions. Allergic and photoallergic responses, and the risk of cross-sensitization with other substances, were given as the reasons for removal. It shows where the weight falls in safety judgments about sunscreens.

Cross-sensitization is a particularly awkward concept to explain. It means a person sensitized to one substance may also react to structurally similar ones, so looking only at what is inside the product does not finish the analysis. In this case, substances outside cosmetics entirely, antibiotics, diuretics, local anesthetics and dyes, were named alongside.

The practical point for a brand is language. To use a sentence like 'gentle even on sensitive skin', you need the basis for it organized in advance. The more regulatory judgment leans toward skin reactions, the more unsupported gentleness claims become the next thing tidied up.

• Does every irritation or sensitivity claim have supporting material behind it?
• Is that material in a form usable under U.S. labeling standards?
• Are you carrying over expressions used in Korea by translation alone?

4. Once outside the monograph, the door is effectively closed

After the effective date, using either substance as a sunscreen active requires an approved new drug application. Formally a route remains open, but for a brand planning sun care as a cosmetic it is not a realistic option. The volume of data and the timelines involved belong to a different world.

This is where the fact that sunscreen is regulated as a drug in the U.S. becomes tangible. A product treated as a functional cosmetic in Korea follows OTC drug rules in the U.S., and its actives must be listed in the monograph to be usable. The principle that what is not on the list cannot go into the formula applies directly.

So formulation freedom for U.S.-bound sun care is narrower than for domestic products. Fixing the range of usable actives early in planning and designing texture and finish within it loses less than building a formula first and fitting the regulation to it afterward.

5. The Korean list and the U.S. list are different tables

The UV filters usable in Korea and those listed in the U.S. monograph are not the same table. A substance long used on one side may not be on the list on the other, and the reverse is equally true. When a substance drops off one side, as here, the gap between the two tables widens further.

For a product intended for export, that difference has to be settled before the formula is fixed. Try to carry one formula into both domestic and U.S. versions, and discovering later that a substance cannot be used on one side leaves the test data and components you already prepared locked together and unable to move.

The realistic alternative is to design for two tracks from the start: build the base formula on substances usable in both, and leave room to adjust by market. Making this decision before formulation begins costs the least.

The first question for the brief

Write this on the first line of the brief: are this sun care product's actives inside the U.S. monograph list as of today, and when, and by whom, was that confirmed? If the era of a list that only grows is over, a compliance finding needs a date attached to it.