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A Korean PA label and a US Broad Spectrum claim report UVA protection in different ways. PA has four PFA-based bands; Broad Spectrum requires a critical wavelength of at least 370 nm. Neither label can be translated directly into the other. Photo by Ana azuria on Unsplash Source: MFDS, September 8, 2016. PA++++ took effect in December 2016. United States (FDA) South Korea (MFDS) UVA claim on the label "Broad Spectrum" — pass/fail only PA+ to PA++++ — a four-tier scale What determines the claim Critical wavelength of at least 370nm PFA (Protection Factor of UVA) value Current test method In vitro, PMMA plate — no human test required for this claim In vivo, human skin-tanning test SPF test Separate, in vivo human test (21 CFR 201.327(i)) Separate, in vivo human test FDA test parameters follow its sunscreen labeling guidance. PA thresholds follow MFDS’s September 8, 2016 announcement. Regulatory history corrected October 14, 2026. What "Broad Spectrum" Actu...

Korea and the United States permit different sunscreen-filter toolkits and use different UVA labels. FDA added bemotrizinol to the US OTC sunscreen monograph in June 2026, but a Korean formula still needs to satisfy US requirements before it can be sold as a US sunscreen. Start with the exact version, its active ingredients and its label. Photo by Maria Lupan on Unsplash Korean cosmetic-safety annex: 32 entries; US OTC sunscreen monograph: 17 actives. Product-specific NDA approvals are outside this comparison. Sources rechecked October 14, 2026. The filter gap, in numbers Sunscreen is regulated as a functional cosmetic in Korea, overseen by the Ministry of Food and Drug Safety (MFDS). In the United States it is regulated as an over-the-counter drug by the FDA. That single classification difference drives almost everything else. Korea’s cosmetic-safety annex contains 32 UV-filter entries after its March 18, 2026 amendment. The US OTC sunscreen monograph contains 17 after ...

A Korean sunscreen can be sold legally in Korea yet fail to meet US sunscreen requirements. The FDA regulates sunscreen as an over-the-counter drug; Korea regulates it as a functional cosmetic. The June 2026 addition of bemotrizinol to the US monograph widened the available filter list, but did not authorize every finished Korean formula for US sale. Photo by Zalfa Imani on Unsplash United States (FDA) South Korea (MFDS) Legal category OTC drug (M020 sunscreen monograph) 기능성화장품 (functional cosmetic) UV-filter list entries 17, after the June 2026 addition 32, after the March 18, 2026 amendment Most recent new filter Bemotrizinol, June 2026 — first monograph addition since 1999 Phenylene bis-diphenyltriazine, added March 2026 Annual OTC facility fee (2024) $22,777–$34,166 per manufacturing site Not applicable — cosmetics aren't drug-registered US monograph count reflects the June 2026 addition; the Korean list follows MFDS Notice 2026-19. OMUFA amounts are explicitly fiscal-...