On September 10, 2026, the U.S. Food and Drug Administration (FDA) issued a final administrative order removing PABA (aminobenzoic acid) and trolamine salicylate from the over-the-counter (OTC) sunscreen monograph. The FDA said that, based on the safety data it reviewed, it determined that the risks of both ingredients outweighed their benefits.[1] However, the FDA also stated that it was not aware of any sunscreen products currently on the U.S. market containing these ingredients, meaning consumers do not need to discard existing products immediately.[1]
What does it mean for an ingredient to be removed from the monograph?
The U.S. OTC monograph is a regulatory framework under which OTC sunscreens that meet certain conditions can be marketed without separate individual approval. Once this action takes effect, products containing PABA or trolamine salicylate as active ingredients cannot be marketed on the basis of that monograph. This should not be interpreted as meaning that all sunscreens worldwide have been immediately recalled.[1]
Korean consumers should check the actual ingredient list and the market where the product is sold
Sunscreens purchased from overseas may have different ingredients and labeling by country, even when they carry the same brand name. First check whether the product is intended for sale in the United States or in another country, then read the active ingredients and directions on the actual container. It is important not to treat every product from the same brand as having the same formulation based on a single ingredient-related news report.
The FDA did not say to reduce sunscreen use
The FDA reaffirmed the public-health benefits of sun protection and advised people to continue using sunscreen along with other forms of protection from the sun.[1][2] The action concerning the two removed ingredients is not a message that “sunscreen is dangerous.” When choosing a product, consider not only its ingredients but also broad-spectrum protection, SPF, water resistance, the amount actually applied, and the possibility of reapplication.
The authorization of new ingredients and the removal of existing ones are part of the same regulatory process
In June 2026, the FDA added bemotrizinol to the list of permitted ingredients under the U.S. OTC monograph, and in September it removed PABA and trolamine salicylate.[1] In other words, the regulatory framework is not a fixed list; it is adjusted as new data and safety assessments emerge. Rather than reading these changes in black-and-white terms—“It was newly added, so it must be the best” or “It was removed, so every older product is dangerous”—consumers should make judgments based on the labeling of products currently on the market.
DERME VERDICT
The key point of the FDA’s decision is a change in U.S. OTC regulation concerning the two ingredients. Rather than discarding the sunscreen you already have out of anxiety, first check its actual ingredient list and the market where it is sold, and prioritize continuing sun protection. Ingredient-related news should be read in the context of regulatory change, not as advertising copy that determines the overall merits of a product.
