Sunscreen Regulation by Country: Korean Sunscreen Exports

Sunscreen regulation by country comes down to one question: is it a cosmetic or a drug? In Korea, sunscreen is a functional cosmetic reviewed or reported to the Ministry of Food and Drug Safety (MFDS); in the EU and Hong Kong it is an ordinary cosmetic.

In the US it is an over-the-counter drug, in Canada a non-prescription drug or natural health product, and in Australia products whose main purpose is sun protection are therapeutic goods. A Korean sunscreen that sells well at home may need a full drug pathway before it can be sold in North America or Australia.

Korean sunscreens are among the most requested K-beauty products, so importers should check this before placing an order. The table reflects regulators’ public material.

Sunscreen regulation by country: comparison table

Swipe sideways to see the whole table.

Korea: functional cosmetic

Under the Cosmetics Act¹, products that help protect skin by blocking or scattering UV rays are functional cosmetics and must be reviewed by, or reported to, the MFDS before sale. Products using notified ingredients within set ranges can be reported; others need a review with supporting data. See our guide to Korean functional cosmetics.

US: OTC drug under monograph M020

US sunscreens must follow FDA’s OTC monograph M020 (PDF)², which fixes permitted active ingredients, maximum concentrations, combinations, labelling and SPF and broad-spectrum testing.

According to FDA’s sunscreen Q&A³, a final order of 10 June 2026 added bemotrizinol to M020, and a final order of 10 September 2026 removed PABA and trolamine salicylate.

Filters common in Korean formulas may still be missing from the list, so compare every formula. As drugs, sunscreens are outside MoCRA cosmetic listing; see our MoCRA guide.

Canada: DIN or NPN

Health Canada’s sunscreen page⁴ says sunscreens are non-prescription drugs or natural health products depending on their active ingredients.

Products using only zinc oxide and titanium dioxide carry an 8-digit natural product number (NPN); those with any chemical filter carry an 8-digit drug identification number (DIN). This is separate from the cosmetic notification covered in our Canada cosmetic notification guide.

EU and Hong Kong: cosmetics

In the EU, sunscreens are cosmetics and may only use the UV filters in Annex VI of Regulation (EC) 1223/2009⁵, within the set limits, with a safety assessment and CPNP notification (CPNP guide). Hong Kong has no pre-market registration; products must meet the general safety requirement of the Consumer Goods Safety Ordinance (Cap. 456)⁶.

Australia: primary sunscreens go to the TGA

The TGA⁷ regulates primary sunscreens as therapeutic goods that must generally be included in the ARTG, with an AUST number on the label.

Some secondary sunscreens, such as moisturisers with SPF, are cosmetics, with ingredient safety overseen by AICIS. The TGA consulted in March 2026 on widening its control over high-SPF claims, so check for a final decision. See Australia AICIS vs TGA.

Checklist before importing Korean sunscreen

• Confirm whether your market treats sunscreen as a cosmetic or a drug.
• Compare each UV filter and its concentration with your market’s permitted list.
• Check that SPF and UVA claims follow your market’s test methods and label rules.
• In drug markets, decide who will hold the licence or listing.

Korean sunscreen brands include Carenology95 and Beauty of Joseon. SEONGWOO GLOBAL supplies Korean skincare to overseas buyers from Seoul; tell us your market when you ask about sunscreens.

Related articles: MoCRA registration · Australia AICIS vs TGA · Mineral vs chemical sunscreen

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See also: Korean sunscreen wholesale compared · SKIN1004 Korean vs US versions