The US Bans Trolamine Salicylate in Sunscreen From September 2027 After the FDA Warned of Potential "Coma and Death"
The US Food and Drug Administration (FDA) has banned two chemicals from US sunscreen, finding that "the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits" (FDA, 2026, p. 2). It found topical trolamine salicylate "is associated with potential serious adverse health effects due to its anticoagulant properties, which may increase the risk of bleeding" (FDA, 2026, p. 5). It found topical PABA "is associated with significant rates of allergic and photoallergic skin reactions, some of which are likely to be severe" (FDA, 2026, p. 4). The ban takes effect on 11 September 2027 (FDA, 2026, p. 6). Australian sunscreens can still contain up to 12% trolamine salicylate.
The US Food and Drug Administration (FDA) has banned two chemicals in sunscreen from September 2027. Its final order, issued on 11 September 2026, bans aminobenzoic acid, known as PABA, and trolamine salicylate "as sunscreen active ingredients" (U.S. Food and Drug Administration [FDA], 2026, pp. 1–2). The order takes effect on 11 September 2027 (FDA, 2026, p. 6).
The FDA's reason was blunt. Its review of the safety data showed "the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits" (FDA, 2026, p. 2). The FDA found "there are no conditions under which a sunscreen drug product containing PABA or trolamine salicylate as a sunscreen active ingredient is GRASE", meaning Generally Recognized As Safe and Effective (FDA, 2026, p. 2). It concluded PABA and trolamine salicylate "are not safe as sunscreen active ingredients under the conditions described in OTC Monograph M020" (FDA, 2026, p. 6). The FDA added that "the repeated application of sunscreen drug products containing PABA or trolamine salicylate as directed in the labeling raises significant concerns about the potential for the increased occurrence of adverse events in consumers" (FDA, 2026, p. 6). The FDA also concluded that "there are significant safety concerns associated with the use of PABA and trolamine salicylate as active ingredients in sunscreen drug products" (FDA, 2026, p. 6).
The FDA's warnings went further. Explaining its 2021 proposal, the FDA said it had tentatively concluded that the risks outweighed the benefits, and that for trolamine salicylate, "these risks include the potential for … salicylate toxicity (vomiting, hyperventilation, metabolic disturbances, coma and death) when this ingredient is used in sunscreens" (FDA, 2021). A 24 July 2024 email from Australia's medicines regulator, the Therapeutic Goods Administration (TGA), released under freedom of information to Council member Joseph Mizikovsky, recorded the same wording (Therapeutic Goods Administration [TGA], 2024a, p. 196). The 2026 final order warned that "at high doses, acute salicylate toxicity (salicylism) may occur", with symptoms of "a more severe intoxication" including "coma" (FDA, 2026, p. 5).
Seven years in the making
Both chemicals were once part of the FDA's sunscreen rulebook. The FDA's 1999 final sunscreen monograph, later stayed, included 16 sunscreen active ingredients, among them PABA and trolamine salicylate (FDA, 2019, p. 6209). In February 2019, the FDA proposed new rules for all 16.
The FDA proposed two as safe. It said it had "sufficient safety data on both zinc oxide and titanium dioxide to support a proposal that sunscreen products containing these ingredients (at concentrations of up to 25 percent) would be GRASE" (FDA, 2019, p. 6206).
It proposed the opposite for PABA and trolamine salicylate, writing that "the risks associated with use of these active ingredients in sunscreen products outweigh their benefits" (FDA, 2019, p. 6206).
The FDA spelled out why. For trolamine salicylate, "these risks include the potential for serious detrimental health effects (including bleeding) caused by the anti-coagulation effects of salicylic acid" (FDA, 2019, p. 6206). An anticoagulant slows blood clotting. For PABA, "the risks include significant rates of allergic and photoallergic skin reactions, as well as cross-sensitization with structurally similar compounds" (FDA, 2019, p. 6206). A photoallergic reaction is an allergic skin reaction set off when sunlight acts on a chemical on the skin. Cross-sensitization means an allergy to one chemical can trigger reactions to chemically similar ones. A TGA document released under a freedom of information request lodged by Council member Joseph Mizikovsky (FOI 26-2156) recorded the FDA's 2021 wording that this cross-sensitization "may lead to allergies to commonly used medications" (TGA, n.d., p. 14).
The other 12 were left in limbo. The FDA found the long-used chemical filters, including oxybenzone, homosalate, avobenzone and octocrylene, lacked enough safety data to be classed safe and effective (FDA, 2019, p. 6206). The FDA said it would address its other proposals "in a future order or future orders" (FDA, 2026, p. 2).
What the FDA found
For PABA, the FDA pointed to the skin. Its 2019 review found "significant numbers of reports of allergic and photoallergic skin reactions to PABA, with rates of PABA-induced skin reactions potentially 8 percent or higher" (FDA, 2019, p. 6219).
The FDA put that number in context. "An 8 percent incidence is a serious concern: By comparison, only 34 hypersensitivity reactions associated with sunscreen products have been identified in FAERS since 1969," it wrote (FDA, 2019, p. 6219). FAERS is the FDA's database of reported side effects.
The harm reaches beyond sunscreen. The FDA's 2019 proposal warned that PABA can sensitize people to similar compounds in widely used products, including sulfonamide antibiotics, thiazide diuretics, local anaesthetics such as benzocaine and procaine, and hair dye (FDA, 2019, p. 6219). "Cross-sensitization to these products is a serious concern, as widespread PABA use could result in a significant increase in cross-reactivity with these agents and the incidence of allergic and photoallergic dermatitis, some of which are likely to be severe," it wrote (FDA, 2019, p. 6219). Dermatitis is inflamed, irritated skin.
The 2026 final order named the same products and went further. "These safety issues alone are reason enough to find PABA not GRASE for use in sunscreen drug products; however, additional data show that PABA also penetrates the skin and enters systemic circulation, raising additional safety concerns," the FDA wrote (FDA, 2026, p. 5).
For trolamine salicylate, the FDA pointed to blood. "FDA located two case reports of serious coagulation-related adverse events associated with liberal dermal application of trolamine salicylate," it wrote (FDA, 2019, p. 6220).
The first case involved an arthritis cream containing trolamine salicylate (Rose & Wiemer, 1983). The patient "continued liberal application of the product to her knees for arthritis pain in the period leading up to her surgery" (FDA, 2019, p. 6220). Four hours after surgery, she "returned to the operating room bleeding profusely from all surfaces that had been operated on" (FDA, 2019, p. 6220). "She lost more than 900 mL of blood," the FDA's 2019 review recorded (FDA, 2019, p. 6220).
In the second case, a patient on the blood thinner warfarin rubbed trolamine salicylate on his neck and shoulders for pain. He had "a considerable increase in prothrombin time (i.e., the time it takes for blood to coagulate)" (FDA, 2019, p. 6220).
A long decline for PABA
PABA's fall started decades ago. In 1999, the Australasian Journal of Dermatology published "The PABA story". Dermatologists "became aware that it was a fairly common sensitizer and that it tended to cross-sensitize with compounds of similar chemical structure both in contact with the skin and given as systemic drugs" (Mackie & Mackie, 1999, Abstract). A sensitizer is a chemical that can set off an allergy. That "played a part in the slow withdrawal of PABA from sunscreens" (Mackie & Mackie, 1999, Abstract).
The reactions kept showing up in clinics. A seven-year study of 4957 patients given light-triggered allergy tests in China found PABA was the second most common cause of reactions: "The most common agents were chlorpromazine (44.3%), followed by para-aminobenzoic acid (14.7%)" (Gao et al., 2014, Abstract).
Australia still lists trolamine salicylate
The European Union has prohibited PABA in cosmetics, including sunscreen, since 11 July 2013 (European Commission, 2013, Art. 2). EU law also bars trolamine salicylate as a sunscreen UV filter. It is not on the EU's list of UV filters allowed in cosmetic products, and cosmetic products "shall not contain" any "UV-filters other than those listed in Annex VI" (European Parliament & Council of the European Union, 2009/2026, Art. 14(1)(e)(i); Annex VI).
Australia followed later. The TGA removed PABA from its permitted ingredients list in November 2022. The TGA's change list read "Aminobenzoic acid | Removal" (TGA, 2022a). A 2022 TGA minute to a deputy secretary, released under freedom of information, had said the TGA would remove PABA "as this ingredient has been identified as not being safe" (TGA, 2022b, p. 216).
Trolamine salicylate is a different story. It is still listed. Australian sunscreens can still contain up to 12% trolamine salicylate (Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2026, item 5069, p. 223). That is the old US limit. The FDA's 1999 monograph included trolamine salicylate "at a concentration of up to 12 percent" (FDA, 2019, p. 6219).
The TGA has had it under review since at least 2022. The same TGA minute recorded the FDA listing trolamine salicylate as "Not GRASE, due to evidence that demonstrates these ingredients are not safe for sunscreens", and said the TGA's Complementary and OTC Medicines Branch was "investigating whether to remove trolamine salicylate from the Determination" (TGA, 2022b, pp. 215–216). The Determination is Australia's list of permitted ingredients. In August 2024, a TGA email told colleagues of "our intentions of removing it from the Permissible Ingredients Determination", and said that if no suppliers were still using the ingredient, "we would be inclined to remove it from the Determination due to safety reasons" (TGA, 2024a, p. 195). More than four years on, trolamine salicylate is still on it.
The TGA also stopped new products. A draft TGA reply to an enquiry said the TGA "took proactive measures to prevent listing of new medicines containing trolamine salicylate in the Australian Register of Therapeutic Goods (ARTG) until an updated safety review could be conducted" (TGA, 2024c, p. 200). On 31 July 2024, TGA staff asked for a "Fail validation" rule for trolamine salicylate, and confirmed it was "due to safety concerns" (TGA, 2024d, pp. 6–7). Internally, staff wrote: "we have very little information about the safety of trolamine salicylate currently" (TGA, 2024b, p. 172). By 30 July 2024, no listed sunscreen on the ARTG contained it, yet it stayed on the list (TGA, 2024a, p. 195).
The Australian Sunscreen Council points to TGA FOI 25-0010, lodged by Australian Sunscreen Council member Joseph Mizikovsky, who exposed what the TGA was doing on trolamine salicylate. It revealed that a TGA email recorded the US FDA's warning that the risks of trolamine salicylate in sunscreens included "the potential for serious bleeding and salicylate toxicity (… coma and death)" (TGA, 2024a, p. 196). The US FDA also warned its topical use "may result in" other adverse effects, including "Reye's Syndrome (in children)" (FDA, 2026, p. 5). The Council is calling for trolamine salicylate to be banned in Australian sunscreen.
Non-nano zinc oxide is the only broad-spectrum UV filter that is reef safe and Generally Recognized As Safe and Effective (GRASE) by the US FDA (NOAA, n.d.; NPS, n.d.; FDA, 2019, p. 6206; Beasley & Meyer, 2010; Hanrahan, 2012).
About the Australian Sunscreen Council
The Australian Sunscreen Council is a registered Australian charity dedicated to improving the health of everyday Australians through UV education, research and evidence-based sun safety initiatives.
As Australia’s peak industry body for sunscreen safety, the Council works with scientists, medical professionals, industry experts and policymakers to advance sunscreen safety, support independent research, improve public understanding of UV exposure and promote stronger public-health standards.
ABN 64 692 134 982
Australian Sunscreen Council Editorial Team
The Council is supported by an Expert Group and may draw on advice from one or more members depending on the subject matter of a particular article, submission or publication. Members listed by the Council include (Australian Sunscreen Council, n.d.):
Dr Craig Downs, Executive Director, Haereticus Environmental Laboratory
Dr Russell Hills, cosmetic and laser dermatologist and Mohs specialist
Dr Denis Dudley, obstetrician-gynaecologist and endocrinologist
Dr Abhinandan “Rocky” Chowdhury, toxicologist
Dr Leslie Laquieze, sunscreen testing and photoprotection
Mgr. Mehrdad Mirzaei, pharmacist and photoprotection researcher
Joseph DiNardo, cosmetic toxicologist
Dr Alan Jones, skin cancer physician
Camila Biato Stopa, MSc, cosmetic scientist and pharmacist
Acknowledgment
Grok was used in the creation of this article. Always read the sunscreen label and use only as directed. Sunscreen is only one part of sun protection. Avoid prolonged sun exposure and wear protective clothing, hats, and eyewear.
References
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