Value Village ／ Beauty
This answer is a draft. It stays unpublished until legal review and source verification are complete.
Japanese cosmetics shelves are full of products marked "medicated" (薬用, yakuyō) or "quasi-drug" (医薬部外品, iyakubugaihin). Visitors often ask whether these are medicines or cosmetics. The category is unique to Japan, and it draws a clear line around what a product may claim.
| Category | Purpose | Approval | Label | Claims allowed |
|---|---|---|---|---|
| Medicines (医薬品) | Medical use and prevention of disease | Each product approved | "Class 1–3 OTC drug" etc. | Approved indications |
| Quasi-drugs (医薬部外品) | Mild action on the body, for specific purposes (prevention, hygiene) | Each product approved (active ingredient and concentration) | "Quasi-drug" (医薬部外品) (the customary word is "medicated", 薬用) | Approved claims: prevents dark spots and freckles, prevents acne, prevents rough skin, prevents body odour, prevents dandruff and itching, etc. |
| Cosmetics (化粧品) | Cleansing, beautifying, adding attractiveness, keeping healthy | Notification only (no approval) | No label, or "cosmetic" (化粧品) | Within the 56 items (moisturises, protects, etc.) |
[Verify] Check the category definitions against Article 2 of the Pharmaceuticals and Medical Devices Act, the scope of quasi-drug claims and active ingredients against MHLW materials, and the Rhododenol history against MHLW's published documents.
"Mild action" is part of the definition of a quasi-drug. Containing an active ingredient and being strong are different things. Cosmetics sometimes contain the same ingredient as a "skin-conditioning ingredient"; the difference is the approved concentration and the claims allowed.
It is not a medicine. It is a quasi-drug. It cannot be used for medical purposes.
The approved "brightening" claim for quasi-drugs is "suppresses melanin production and prevents dark spots and freckles" — that is, prevention. No cosmetic or quasi-drug is approved to remove spots that already exist. That is the domain of a dermatology clinic (covered by Japanese health insurance).
As the Rhododenol case shows, quasi-drugs can also cause serious skin trouble. If your skin reacts, stop and see a dermatologist.
The quasi-drug is a category unique to Japan. "Cosmeceutical" abroad is not a legal term; the US has two categories (cosmetics and drugs), and the EU has one (the Cosmetics Regulation). When a Japanese quasi-drug is sold abroad, it is handled locally as either a "cosmetic" or a "drug".
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https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/keshouhin/index.html
https://www.mhlw.go.jp/stf/houdou/0000037143.html
⚠️ Editorial note: the source URLs above were identified by search. Our working environment cannot reach go.jp domains, so the contents have not been checked against the text. Verify every source before publication and record who checked it and when.
What we share here are ideas and everyday practices passed down among people living in Japan, together with general information drawn from public sources. They are not official recommendations, and they are not professional instruction. Practices vary between households and regions.
This is general information. Results vary from person to person and depend on your own conditions and surroundings.
Please decide for yourself, using your own judgement, whether any of this suits your situation. We cannot accept responsibility for any damage, loss or injury arising from following this article.
Cosmetics are not medicines and are not meant to diagnose, heal or prevent any condition. If your skin reacts, stop using the product and see a dermatologist.
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