Japanese sunscreens and skincare can cause trouble in an importer’s notification file even when nothing is wrong with the product. The reason is that Japan sorts these products into two legal categories, cosmetics and quasi-drugs, and the importer’s own market sorts them by its own rules. A product that is straightforward in Japan can need a second look where you sell it.
This guide is for importers and wholesalers buying finished Japanese sunscreens and skincare. It covers how to read the Japanese category off the pack, why that category does not settle the question in your market, what to do with the SPF and PA numbers, and how to keep claims within what the rules support.
💬 Buying Japanese sunscreen or skincare for your market? Sunsho Trade buys Japanese cosmetics in Japan and exports them, and tells you how each product is classified in Japan. Send us your product list.
Read the Japanese category off the pack first
A Japanese quasi-drug must carry the words “医薬部外品” on its container, so a photo of the pack tells you whether a sunscreen or skincare product is a cosmetic or a quasi-drug in Japan.
Japan’s Act on Pharmaceuticals and Medical Devices (the PMD Act) defines both categories in Article 2. A cosmetic is a product applied to the body to clean, beautify, increase attractiveness, alter appearance, or keep the skin or hair healthy, whose action on the body is mild (Article 2(3)). A quasi-drug is a product with a mild action on the body that falls within the purposes listed in Article 2(2), or that the Minister of Health, Labour and Welfare designates.
The two categories reach the Japanese market by different routes. A quasi-drug generally needs product-by-product approval from the Minister (Article 14(1)). A cosmetic is generally notified rather than approved (Article 14-9), except for cosmetics containing ingredients the Minister designates, which need approval. That is why some Japanese sunscreens and skincare products are cosmetics and others, often sold as medicated products, are quasi-drugs.
For a buyer, the label is enough to sort the list. Article 59 requires a quasi-drug’s container to show the words “医薬部外品”. A cosmetic does not carry those words, and lists its full ingredients under Article 61. The other label items, including lot numbers and the absence of a printed date on many cosmetics, are covered in our Japanese cosmetics wholesale guide.
| What you see on the Japanese pack | Category in Japan | What to ask before ordering |
|---|---|---|
| ”医薬部外品” printed on the container | Quasi-drug | How does your market classify this product, and can it be notified there as it is? |
| No “医薬部外品”, full ingredient list | Cosmetic | Do the ingredients, including UV filters, meet your market’s lists? |
| Spray or mist format | Either, plus a transport question | Is it an aerosol or alcohol-rich product that may be dangerous goods? |
| SPF and PA numbers | Either | Does your market have its own rule on how SPF is shown? |
Japan’s category does not decide the category in your market
Your market applies its own definition of a cosmetic, so a product that is a quasi-drug in Japan may be notified as a cosmetic elsewhere, or may need a different route, and the importer confirms which.
The ASEAN Cosmetic Directive framework is a useful example. The ASEAN Secretariat’s illustrative list of cosmetic products includes sunbathing products, skin-whitening products, anti-wrinkle products, deodorants, and products for the care of the teeth and mouth. Several of these categories contain products that are quasi-drugs in Japan. Annex VII of the Directive, the list of UV filters cosmetic products may contain, refers to “cosmetic sunscreen products”. In markets that follow the ASEAN framework, a sunscreen is generally handled as a cosmetic.
That does not mean a Japanese quasi-drug can always be notified as a cosmetic as it stands. The ASEAN claim guidelines say a product is classified as a cosmetic or a drug on two factors, its composition and its proposed use. An active ingredient, its concentration, or a claim on the pack can each push a product out of the cosmetic category. The importer’s authority makes that call, not the Japanese label.
Outside the ASEAN framework, do not assume the same answer: each market sets its own boundary between cosmetics and medicines. The importer confirms the current rule in its country, for each product, before the order is placed.
What we provide for that check:
- the Japanese category of each product, read from the pack;
- photos of every face of the pack;
- the full ingredient list, with INCI conversion where the manufacturer’s information allows;
- for quasi-drugs, the active ingredients as shown on the Japanese label.
💬 Not sure whether a Japanese quasi-drug can be sold in your market? Send the products, and we will give you the Japanese category and the label information your import side needs to decide. Ask about classification.
Treat SPF and PA as label information, not as a claim you can rewrite
The SPF and PA figures on a Japanese sunscreen come from tests run for the Japanese market, so carry them over only in the form your market accepts, and check every UV filter against your market’s list.
In Japan, SPF and PA are measured and displayed under industry voluntary standards set by the Japan Cosmetic Industry Association, not under a national law. The figures on the pack reflect tests the manufacturer arranged for that formula. The method and display rules are explained in detail in our guide to Japanese sunscreen OEM, SPF and PA testing, which is written for brands developing their own product. For a buyer of finished products, three points matter:
- Your market’s display rules may differ. PA is the display format used in Japan. Your market may have its own way of showing UVA protection, or its own rule on how high an SPF figure may be stated. The importer checks this before the local label is designed.
- UV filters are checked one by one. Annex VII of the ASEAN Cosmetic Directive lists the UV filters cosmetic products may contain, with maximum concentrations and conditions. The current version on the ASEAN Secretariat’s site is version 2025-2, dated 12 December 2025. The annex is revised, so the importer should check against the version in force on the filing date.
- Label warnings may be added. Annex VII sets a warning for primary sunscreen products in markets that follow it: “Do not stay too long in the sun, even while using a sunscreen product.” The importer adds what its market requires.
Never adjust an SPF or PA figure on the local label to match a competitor or a customer’s request. The figure belongs to the test, not to the marketing.
Keep claims within what the rules support
Translate only the claims your market allows for the category the product will take there, and never add a claim the Japanese pack does not make.
Japanese cosmetics may only claim effects within the efficacy range set by the Ministry of Health, Labour and Welfare. That range includes two items written for sun products: “prevents sunburn” (item 36) and “prevents spots and freckles caused by sunburn” (item 37). Quasi-drugs make claims based on their approval, which can go beyond the cosmetic range. The full range is listed in the 56-item efficacy range for Japanese cosmetics.
For an exporter, the risk runs in both directions:
- A quasi-drug claim on a product notified as a cosmetic. If your market treats the product as a cosmetic, a claim that is lawful for a Japanese quasi-drug may be one your market does not allow for a cosmetic. The importer decides what stays on the local label.
- A claim added in translation. A short Japanese phrase can become a stronger English or local-language claim through loose translation. Translate literally first, then check.
- Claims in marketing, not on the pack. Product listings, social posts and shop displays are usually covered by advertising rules as well as labelling rules. The importer and its sellers should apply the same check.
Sunsho Trade does not make efficacy claims for any product. We pass on what the Japanese pack says, translated, and leave the decision on local claims to the importer.
Plan sprays, mists and the rest of the skincare range
Spray sunscreens and alcohol-rich toners may be dangerous goods in transport, and creams and lotions may need protection from heat, so plan the shipment around the most demanding products.
A spray sunscreen in an aerosol can, a fixing mist or an alcohol-rich toner may be classed as dangerous goods for sea or air transport. The safety data sheet (SDS) of each product states the transport classification, and the carrier’s rules decide whether and how it travels. How to spot these products in a long list is set out in Japanese household goods wholesale, and how they affect a shared load in Japanese food, cosmetics and household goods in one container.
Creams, emulsions and sunscreen lotions are formulated to be stored as the pack states. A long sea route in a hot season can expose them to more than that. Ask whether the route and the warehouses at both ends can hold the goods within the storage conditions on the pack, and consider shipping the most sensitive lines in a cooler month or in a temperature-controlled container.
💬 Ready to price an order of Japanese sunscreen and skincare? Send the lines, your country and whether any are sprays, and we will come back with the classification and shipping points. Request a quotation.
Frequently asked questions
1. How do we know whether a Japanese sunscreen is a quasi-drug?
Look at the container. Japan’s PMD Act requires a quasi-drug to carry the words “医薬部外品”. If those words are absent, the product is sold in Japan as a cosmetic, with its full ingredient list on the pack.
2. Is a Japanese quasi-drug sunscreen a cosmetic in our market?
It depends on your market. In markets following the ASEAN Cosmetic Directive, sunscreens are generally handled as cosmetics, but composition and claims can change the answer. The importer confirms the current rule in its country before the order.
3. Can we keep the SPF and PA figures on our local label?
Only in the form your market accepts. PA is the display format used in Japan, and your market may have its own rules for showing UVA protection or stating SPF. The figures should never be changed to suit marketing.
4. Do you make claims about what the products do?
No. We pass on what the Japanese pack says, translated, together with the Japanese category. Which claims may appear on the local label is for the importer to decide under its market’s rules.
5. Can spray sunscreens be shipped with the rest of the order?
Sometimes. Aerosols may be dangerous goods in transport. The SDS gives the classification, and the carrier decides whether and how they can be loaded with other goods. We check this before the shipment is booked.
Sources: Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), Articles 2(2), 2(3), 14(1), 14-9, 59 and 61, e-Gov law search; Ministry of Health and Welfare notice of 28 December 2000 and Ministry of Health, Labour and Welfare notice of 21 July 2011 on the efficacy range of cosmetics, as published by Osaka Prefecture; ASEAN Secretariat, ASEAN Definition of Cosmetics and Illustrative List, ASEAN Cosmetic Claim Guidelines (Appendix III), and Annex VII (version 2025-2, 12 December 2025). Checked on 24 October 2026.