Korean Sunscreen Manufacturers: How to Find and Check One (2026)
Korea’s official records show which companies have put sunscreens through the Ministry of Food and Drug Safety (MFDS). They don’t prove a company made those sunscreens, and they say nothing about the United States, where sunscreen is a drug.
This guide is for brands planning a sunscreen with a Korean manufacturer: what a Korean filing does and doesn’t show, how to use the filings to start a shortlist, and the checks that only you can make.
1. What a Korean sunscreen filing shows
In Korea, a product that helps protect the skin from ultraviolet light is a functional cosmetic (기능성화장품) under the Cosmetics Act. Before it is sold, each product must be reviewed by MFDS or reported to it, one product at a time (Article 4). MFDS publishes both, as reviewed products and reported products, under the name of the company that filed.
The filer can be a registered manufacturer, a responsible distributor (the company that puts the product on the market, often the brand), or a qualifying university or research institute. So a filing names the filer, not necessarily the factory:
- When a brand files, the factory that made the product may not appear in the record at all.
- When a manufacturer files, it may be acting as the product’s distributor: about nine in ten registered manufacturers also hold a distribution registration. The filing shows the company put a sunscreen through MFDS, not that it made that sunscreen itself.
2. Building a shortlist
The filings are still the best public starting point, because they connect a sunscreen to a named company. K-Beauty Database covers 3,983 companies registered with MFDS as cosmetics manufacturers. 277 of them have sunscreen evidence on record. For almost all of them, that evidence is a sunscreen in MFDS’s list of reviewed functional cosmetics, filed under the company’s own name; for a few, it is only what the company publishes about itself.
Read that number for what it is: registered manufacturers with a sunscreen filing or claim, not a list of companies that will make a sunscreen for you. It doesn’t show who manufactured the product, whether the company still makes sunscreens, or whether it takes outside brands. Whether a company offers OEM or ODM service is a separate question that only the company can answer.
The reverse also holds: a manufacturer with no filings of its own may make sunscreen for brands that file under their own names. Ask before you rule anyone out. And before going further with any candidate, confirm its manufacturing registration and business status; the guide to finding and verifying Korean cosmetics manufacturers covers those checks.
3. Checking a candidate
- Ask for sunscreens it has made, and look them up. Ask for products in your format (cream, stick, cushion, spray) that it can share, and search them in MFDS’s reviewed and reported lists. Where a client brand is the filer, the record won’t name the factory, so ask the manufacturer to confirm in writing that it made the product.
- Pin down the site. Ask which of its sites would make your sunscreen, and whether any step (bulk production, filling, packing) happens elsewhere. If GMP matters to you, check that site’s MFDS CGMP designation; the Korean CGMP guide explains what it covers.
- Ask for the SPF test reports for the formula you will buy. Ask who ran each test, at which lab, and to which market’s method. A test done for a Korean filing does not automatically carry over to another market; the United States, for one, sets its own procedures (section 4).
- Check the UV filters against each market you will sell in. Markets permit different sunscreen ingredients, so a formula sold in Korea may need changes elsewhere. Settle this before you approve a sample.
4. Selling in the United States
In the United States, sunscreen is an over-the-counter drug, with its own labeling rules and SPF and broad-spectrum test procedures, set out in FDA’s sunscreen monograph (M020). That brings drug requirements for the factory:
- Every foreign establishment that manufactures a drug for import into the United States must register with FDA (21 CFR 207.17), and each drug it makes must be listed (21 CFR 207.41). FDA publishes registered establishments; search it for the site that would make your product.
- Registration is not approval. FDA states that registering an establishment or listing a drug does not denote approval of the establishment or the drug (21 CFR 207.77), so treat “FDA registered” as a filing, not a quality mark.
- Drug manufacturing is held to FDA’s good manufacturing practice rules for finished drugs. Ask how the site meets them; a Korean CGMP designation is a cosmetics standard, not FDA drug GMP.
K-Beauty Database holds no FDA data, so these checks are yours to make.
5. Selling in the EU
In the EU, sunscreen is a cosmetic. Only the UV filters listed in Annex VI of the Cosmetics Regulation may be used, and only within the conditions set there (Article 14). The Commission’s non-binding recommendation on sunscreen efficacy (2006/647/EC, still in force) sets out how protection claims should be supported, including UVA protection of at least a third of the labelled SPF. Ask whether the formula has been checked and tested for the EU, and who will supply the data your EU responsible person needs.
6. Commercial questions
None of these is in any official record. Ask in writing.
- Do you take on new brands for sunscreen at our order size, and is that OEM (our formula) or ODM (yours)?
- What is the minimum order for this sunscreen, and do tubes, sticks or cushion cases carry their own minimums?
- Who pays for stability and packaging-compatibility testing, and how long does it take?
- For the United States: who will register the site and list the product with FDA, and at whose cost?
- If we move production later, do we keep the formula and the test data?
Sources
- Cosmetics Act (화장품법), Article 2: definitions, including functional cosmetics. Korean Law Information Center
- Cosmetics Act (화장품법), Article 4: review of functional cosmetics. Korean Law Information Center
- MFDS 의약품안전나라: functional cosmetics, reviewed products (기능성화장품제품정보 심사)
- MFDS 의약품안전나라: functional cosmetics, reported products (기능성화장품제품정보 보고)
- FDA OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, including labeling and the SPF and broad-spectrum test procedures (OTC Monographs@FDA)
- 21 CFR 207.17: who must register a drug establishment with FDA, including foreign establishments
- 21 CFR 207.41: who must list drugs with FDA
- 21 CFR 207.77: registration and listing do not denote FDA approval
- 21 CFR Part 211: current good manufacturing practice for finished drug products
- U.S. FDA: Drug Establishments Current Registration Site
- EU Cosmetics Regulation (EC) No 1223/2009: Article 14(1)(e) and Annex VI, UV filters allowed in cosmetic products
- Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and the claims made relating thereto
Manufacturer counts are from K-Beauty Database’s current dataset. This guide is general information, not legal or regulatory advice. Regulations change; confirm current requirements with the official sources or a qualified adviser before you rely on them.