Why the FDA Is Removing Two Old Sunscreen Filters

Updated 5 October 2026. The final order was issued on 10 September 2026; under the CARES Act it cannot take effect earlier than one year after issue, so the filters remain technically listed until that date.

Two names most people have not seen on a bottle in years got a formal goodbye from the US Food and Drug Administration on 10 September 2026, when the agency issued a final administrative order that removes aminobenzoic acid (better known as PABA) and trolamine salicylate from the list of actives allowed in over-the-counter sunscreens sold under the sunscreen monograph. The Federal Register published notice of that order the next day [1].

In plain terms: once the order takes effect, those two filters will no longer be “generally recognised as safe and effective” for OTC sunscreen use. FDA says the available safety data show the risks outweigh the benefits [1] [2].

What the OTC sunscreen list actually is

In the United States, most drugstore sunscreens are not approved one formula at a time the way a new prescription drug is. They follow a public playbook (the OTC monograph) that names which UV filters may be used, at what kinds of conditions, without each brand filing a full new drug application.

If a filter is on that list under the right conditions, a product that follows the monograph can be marketed as an OTC sunscreen. If a filter is struck from the list, a sunscreen that still relies on it as an active is no longer covered by that pathway. Continuing to sell it as an OTC sunscreen would require a different legal route, such as an approved application, rather than monograph marketing [1] [2].

That is the machinery behind the 10 September 2026 order. It is not a recall of modern mineral or common chemical sunscreens. It is a tidy removal of two legacy actives FDA had already proposed to drop in 2021 [2].

Why these two, and why now

aminobenzoic AcidAminobenzoic AcidLimitedPABA · Organic UV filter (aminobenzoate)Legacy sunscreen filter FDA has determined is not GRASE; removed from OTC Monograph M020 by final order OTC000008-1.Open in the Index → (PABA) is an old UVB filter with a long history of contact and photoallergic reactions in clinical experience. trolamine SalicylateTrolamine SalicylateLimitedTrolamine Salicylate · Organic UV filter (salicylate salt)Legacy sunscreen active FDA has determined is not GRASE; removed from OTC Monograph M020 alongside PABA.Open in the Index → is a salicylate-type sunscreen active that likewise sat on the historical monograph list.

FDA’s 2021 proposed order had already sorted sunscreen actives into three buckets: proposed GRASE (then zinc oxide and titanium dioxide), not GRASE on safety grounds (PABA and trolamine salicylate), and not GRASE because more data were needed for a dozen other organic filters [2].

For PABA and trolamine salicylate, FDA chose to finalise the safety cut without waiting for every other open monograph question (labelling, dosage forms, maximum SPF, and the “more data needed” filters). The Q&A is explicit: more than 15,000 comments landed on the 2021 proposal, and finishing these two removals now avoids parking an already-clear safety call behind that backlog [2].

What shoppers should do (almost nothing)

FDA’s consumer message is unusually calm. People do not need to take action because of the announcement. The agency says it is not aware of any sunscreen drug products currently sold in the US that contain PABA or trolamine salicylate [2].

So this is closer to closing an obsolete chapter than to yanking today’s shelf stock. Keep using a broad-spectrum sunscreen you already trust, with clothing, shade and other sun habits. The public-health case for sunscreen use still stands; FDA says as much while it edits the ingredient list [2].

How to read the Drug Facts box after this

When you turn a US sunscreen around, the “Active ingredients” line is the monograph talking. You will still see names such as zinc oxide, titanium dioxide, avobenzone, octinoxate and others, depending on the formula. You should not expect to see PABA or trolamine salicylate on anything new built for the US OTC channel once the order’s effective date is reached.

Under the CARES Act framework FDA uses for monograph orders, a final sunscreen order cannot take effect earlier than one year after it is issued. The precise calendar date is stated in the order itself on the OTC Monographs@FDA portal [2]. Until that date arrives, the practical shopper takeaway is still the same: these two actives were already rare to absent on US shelves.

What this does not settle

This order does not finish the rest of the 2021 sunscreen rewrite. Maximum labelled SPF, spray and powder questions, broad-spectrum rules, and the large “additional data needed” group of organic filters remain for future orders [2]. Removing two old filters is a discrete safety action, not the last word on every UV filter in the aisle.

For Index readers, the entries for aminobenzoic AcidAminobenzoic AcidLimitedPABA · Organic UV filter (aminobenzoate)Legacy sunscreen filter FDA has determined is not GRASE; removed from OTC Monograph M020 by final order OTC000008-1.Open in the Index → and trolamine SalicylateTrolamine SalicylateLimitedTrolamine Salicylate · Organic UV filter (salicylate salt)Legacy sunscreen active FDA has determined is not GRASE; removed from OTC Monograph M020 alongside PABA.Open in the Index → now read as regulatory history with a Limited evidence grade for modern OTC sunscreen use: documented filters whose US monograph pathway FDA has closed on safety grounds [1].

Bottom line

FDA has finalised what it proposed years ago: PABA and trolamine salicylate are being removed from the OTC sunscreen monograph because the agency no longer considers them GRASE for that use [1] [2]. Enthusiasts do not need a panic shop. Check labels if you are curious; expect empty results; keep the sunscreen habit with filters that remain on the list.