FDA removes PABA and trolamine salicylate from sunscreen: the order takes effect September 11, 2027, and none of the 29 FDA listings with either is a sunscreen
The FDA has issued an order that takes PABA (aminobenzoic acid) and trolamine salicylate off the list of active ingredients a US sunscreen may use without an approved application of its own. The order, OTC000008-1, was issued in September 2026 and takes effect on September 11, 2027. From then on, a sunscreen with either one as an active ingredient needs an approved new drug application.
On October 4, 2026 we searched the FDA's drug directory for both ingredients. It has 29 listings with one of them, and none is a sunscreen. The 3 PABA listings are two homeopathic products taken by mouth and one bulk raw material. The 26 trolamine salicylate listings are pain-relief creams, lotions and sprays. The FDA says the same thing in its own words: "FDA is not aware of any sunscreen drug products currently sold in the U.S. that contain PABA or trolamine salicylate."
We report what the order and the FDA's records say. We do not describe what either ingredient does to skin beyond quoting the FDA, and this page is not advice about any product you use.
What the order says
Final Administrative Order OTC000008-1, Section VI, Effective Date
"This final order shall take effect - (a) September 11, 2027; or (b) if the final order is disputed under section 505G(b) of the FD&C Act, in accordance with section 505G(b)(2)(A)(iv)(I) of such Act."
Quoted from the order, which is dated as issued September 11, 2026. The order is a work of the US federal government. Read October 4, 2026.
- Two entries come off the list. The order deletes (a) aminobenzoic acid (PABA) and (p) trolamine salicylate from section M020.10, the list of sunscreen active ingredients. In the version of that list set in June 2026, PABA was allowed up to 15 percent and trolamine salicylate up to 12 percent. The list goes from 17 ingredients to 15.
- After the effective date, either one makes a sunscreen a new drug. "When this final order goes into effect, drug products containing PABA or trolamine salicylate as sunscreen active ingredients will be new drugs under section 201(p) of the FD&C Act and subject to the requirements for an approved new drug application under section 505 of the FD&C Act."
- The one-year wait comes from the law. The FDA's question-and-answer page: "The CARES Act specifies that the effective date for these sunscreen final orders cannot be earlier than one year after issuance of the final order."
- Nobody gets a head start. Section V: "This final order does not have the effect of authorizing marketing exclusivity for any entity." The June 2026 order that added bemotrizinol did grant exclusivity, to DSM and its licensees.
Why the FDA says it removed them
The order gives one reason for both: the FDA's review of the safety data shows that "the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits". The Federal Register notice puts the result in one line: "A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE)."
For PABA, the order says: "Topical use of PABA is associated with significant rates of allergic and photoallergic skin reactions, some of which are likely to be severe."
For trolamine salicylate, the order ties its concern to the way sunscreen is used: "If trolamine salicylate were to be applied to all skin exposed to the sun and reapplied every 2 hours as directed in the labeling … the potential for transdermal absorption and systemic availability of substantial amounts of salicylic acid raises significant concerns".
Both proposals date from 2021, and the order says the comments on them changed nothing: "FDA did not make any changes to the final order based on consideration of these comments." Back then, the FDA had already written of PABA: "Our review of more than 700 sunscreen brands sold in the United States (FDA 2019c) indicates that PABA is in fact no longer being marketed in the United States."
The dates
| Date | What happened | Source |
|---|---|---|
| 2021-09-24 | FDA issues proposed order OTC000008, which proposes, among much else, removing PABA and trolamine salicylate | Order, Section I |
| 2021-09-27 | The proposed order is announced in the Federal Register (86 FR 53322). The comment period is extended on November 22, 2021 | Federal Register notice |
| 2026-06-10 | Order OTC000039 adds bemotrizinol. Its list still has PABA and trolamine salicylate | Order OTC000039 |
| 2026-09-10 | The date the FDA's question-and-answer page gives for the new order. The Federal Register notice is filed the same day | FDA Q&A, Federal Register |
| 2026-09-11 | Order OTC000008-1 is dated as issued. The notice is published in the Federal Register (91 FR 57892) | Order, Federal Register |
| 2027-09-11 | The order takes effect, unless it is disputed | Order, Section VI |
PABA and trolamine salicylate in the FDA's records
| Ingredient | Listings | What they are | Sunscreens |
|---|---|---|---|
| PABA (aminobenzoic acid) | 3 | Two homeopathic products taken by mouth (E.O.L. by InLight Creation, B Complex Liquescence by Nutritional Specialties) and one bulk powder (Cambrex Karlskoga AB) | 0 |
| Trolamine salicylate | 26 | Pain-relief creams, lotions and sprays for the skin, including Aspercreme Pain Relieving (Chattem), Blue-Emu, Mobisyl, and store brands sold as Equate, CVS, Walgreens and Meijer | 0 |
| Padimate O, which stays on the list | 3 | Vertra Pearl White Face Stick SPF 50, filed by two companies, and one Revlon lip product, EA Eight HR Lip Sheer Tints | 3 |
All 26 trolamine salicylate listings are for use on the skin, and their labels describe them as topical analgesics or as relieving minor aches and pains of muscles and joints. Most list trolamine salicylate at 10%.
The FDA's label database reaches further back, because it keeps labels for products that are no longer listed. None of its labels lists PABA itself as a sunscreen active ingredient. Searching the active-ingredient section of every label for aminobenzoic returned 8 labels, and for PABA 21. They are homeopathic products, three sunscreen labels that say they contain no PABA, three pain-relief labels that warn people allergic to PABA, and nine labels that use the names Octyl Dimethyl PABA or Ethylhexyl Dimethyl PABA, seven of which code the ingredient as padimate O.
The same search for trolamine returned 109 labels, and one is a sunscreen: a foundation labeled ELF Flawless Finish Foundation SPF 15 Oil Free, filed by J. A. Cosmetics U.S. Inc, with trolamine salicylate 2% and titanium dioxide 5.5% on its label. The label's marketing dates run from October 3, 2011 to December 31, 2017.
What PABA-free means on a label
The order defines the word in a footnote: "Aminobenzoic acid is also known as para-aminobenzoic acid or PABA." The phrase PABA free has no definition in the sunscreen monograph. It does not appear in the order, including the full text of the revised monograph that the order prints.
One ingredient with PABA in its other names stays on the list: padimate O, up to 8 percent. Some labels print both names. Continental Vitamin Company's Lip Healer SPF 15, marketed from 2016 to 2020 according to its label, lists "Ethylhexyl Dimethyl PABA (Padimate O) 7%". In the directory today, padimate O is in the three listings in the table above, two of them Vertra's face stick at padimate O 7% with titanium dioxide 17%.
Trolamine salicylate creams are a different category
Trolamine salicylate is also the active ingredient in pain-relief creams such as Aspercreme Pain Relieving. The order deals with trolamine salicylate "as a sunscreen active ingredient", and it does not mention pain-relief products. Every directory listing with trolamine salicylate is a pain-relief product. This page does not assess them.
What the order does not decide
The 2021 proposal covered much more than these two ingredients, and the FDA is splitting it up. Its question-and-answer page: "FDA received over 15,000 public comments for the 2021 sunscreen proposed order (OTC000008), many of which are substantive and require extensive scientific review." And: "FDA is actively working through the remaining provisions - including labeling, dosage forms, and maximum SPF levels - and will address those provisions in future order(s), as appropriate."
The order says those future orders will also settle the other filters in the 2021 proposal, including the 12 it said needed more data, among them avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone and padimate O. All 12 stay on the list for now. The FDA adds: "The 2021 proposed order (OTC000008) does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens."
What we could not confirm
- Whether anyone will dispute the order, which would move its effective date. We did not check a docket for a dispute.
- Whether a sunscreen with PABA or trolamine salicylate is sold in the US without an FDA listing. We searched the FDA's records, not stores.
- Whether the ELF Flawless Finish Foundation SPF 15 was sold after 2017. Its label gives a marketing end date of December 31, 2017, and nothing after it.
- Which of Revlon's two Eight Hour lip listings contains padimate O. The directory codes the Lip Sheer Tints with padimate O, but that label's Drug Facts text lists octinoxate, oxybenzone and avobenzone. The Eight Hour Lip Protectant SPF 15 is coded the other way round, and its label text lists padimate O 8.0%.
- Why the dates differ by a day. The FDA's question-and-answer page dates the order September 10, 2026; the order itself says it was issued on September 11, 2026.
Questions
Is PABA banned in US sunscreen?
What does PABA-free sunscreen mean?
Does the order affect trolamine salicylate creams such as Aspercreme?
When does the change take effect?
Does the order change SPF limits or sunscreen labels?
Sources
- Effective date, removed ingredients, exclusivity, reasons and the revised ingredient list - FDA Final Administrative Order OTC000008-1, dated as issued September 11, 2026, Sections IV to VI and IX; read October 4, 2026
- The order's page on OTC Monographs@FDA - Order OTC000008, read October 4, 2026
- The notice in the Federal Register - Federal Register document 2026-18551, 91 FR 57892, published September 11, 2026; read October 4, 2026
- The FDA's dates and statements - Questions and Answers: FDA's regulatory actions on over-the-counter sunscreen, content current as of September 10, 2026; read October 4, 2026
- The 2021 proposal - FDA Proposed Administrative Order OTC000008, September 24, 2021; read October 4, 2026
- The ingredient list before this order, with PABA up to 15 percent and trolamine salicylate up to 12 percent - FDA Final Administrative Order OTC000039, June 10, 2026; read October 4, 2026
- Directory listings - openFDA drug/ndc API, active ingredient name searched for aminobenzoic acid, trolamine salicylate and padimate O, run October 4, 2026
- Labels, including old ones - openFDA drug/label API, active ingredient section searched for aminobenzoic, PABA and trolamine (109 results, read in two pages), run October 4, 2026
- Individual labels - DailyMed: ELF Flawless Finish Foundation SPF 15, Lip Healer SPF 15, Vertra Pearl White Face Stick (Eai-jr 286), Vertra Pearl White Face Stick (Toshiki Pigment), EA Eight HR Lip Sheer Tints and Eight Hour Lip Protectant SPF 15, read October 4, 2026
Source links are not affiliate links. This page reads a public federal order and FDA records and reports what they say. It is not legal advice, it is not medical advice, it is not advice about your skin, and it does not describe what any product or ingredient will do.
