{"title":"FDA — Q&A: New Requirements for OTC Sunscreen Products Marketed in the U.S.","entity_type":"Source","slug":"fda-otc-sunscreen-qa","canonical_url":"https://skinknowledgebase.com/sources/fda-otc-sunscreen-qa","dates":{"date_modified":"2026-05-09","date_reviewed":"2026-05-09"},"mcp_eligible":true,"evidence_sources":[],"product_fact_sources":[],"related_entities":[{"title":"Oxybenzone","url":"https://skinknowledgebase.com/ingredients/oxybenzone"},{"title":"Photoallergic Contact Dermatitis from UV Filters","url":"https://skinknowledgebase.com/side-effects/photoallergic-contact-dermatitis-uv-filters"},{"title":"Avobenzone","url":"https://skinknowledgebase.com/ingredients/avobenzone"},{"title":"Titanium Dioxide","url":"https://skinknowledgebase.com/ingredients/titanium-dioxide"},{"title":"Zinc Oxide","url":"https://skinknowledgebase.com/ingredients/zinc-oxide"},{"title":"Sun Damage","url":"https://skinknowledgebase.com/concerns/sun-damage"},{"title":"What SPF should I use every day?","url":"https://skinknowledgebase.com/questions/what-spf-should-i-use-every-day"},{"title":"Is mineral sunscreen better than chemical sunscreen?","url":"https://skinknowledgebase.com/questions/is-mineral-sunscreen-better-than-chemical-sunscreen"}],"body_sections":[{"heading":"Quick Summary","paragraphs":["The FDA Q&A explaining the U.S. labeling reform that introduced the modern broad-spectrum requirement, the water-resistance language rules, and the SPF threshold above which sunscreen products may carry the appearance-of-skin-aging claim. It is the regulatory document that defines what U.S. sunscreen labels are allowed to say and under what conditions."]},{"heading":"What Studied","paragraphs":["Not a study. This is a regulatory Q&A from the FDA detailing the current U.S. OTC sunscreen labeling rules. It covers what counts as broad-spectrum, how water-resistance must be expressed, and the SPF threshold tied to the appearance-of-aging claim."]},{"heading":"Main Findings","paragraphs":["The page establishes that products meeting the FDA's broad-spectrum test at SPF 15 or higher may carry the cosmetic-appearance claim of helping reduce the appearance of skin aging caused by the sun. Products that are not broad-spectrum, or that fall below SPF 15, may not. It also defines water-resistance labeling (40 or 80 minutes) and prohibits unqualified terms like \"sunblock,\" \"waterproof,\" or \"sweatproof.\""]},{"heading":"Why It Matters","paragraphs":["For a daily-SPF Question, this regulation is the reason \"broad-spectrum\" matters more than any single SPF number. It is also the regulatory anchor for the cosmetic-appearance scope — appearance of premature wrinkles, dark spots, and photoaging — that this Question stays inside per Cross-batch Rule 4."]}],"source_type":"regulatory","original_source_url":"https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-announces-new-requirements-over-counter-otc-sunscreen-products-marketed-us"}