Updated 27 August 2026
A customer in Berlin photographed the side of a box last week and sent me one question: is this a medicine? The box was a toner. The characters she had circled were 医薬部外品, sitting in a tidy little frame just above the ingredient list, and nothing on the front of the carton explained them.
That message arrives often enough to deserve its own guide. 医薬部外品 — iyakubugaihin, usually translated as "quasi-drug" — is a real category under Japanese law and the most misread thing on a Japanese beauty label. It is not a medicine. It is not ordinary cosmetics either. And the part almost every shop leaves out: it is not a quality mark. I live in Japan and ship these products from Kobe every week, so this is the counter explanation, written down.
The three tiers of the Japanese system
Japan's Pharmaceuticals and Medical Devices Act sorts everything you might put on your skin, hair or teeth into three tiers. Almost every confused argument about Japanese skincare online comes from people comparing products that sit on different tiers without knowing it.
化粧品 (keshōhin) — cosmetics
The base tier, and the biggest by far. A cosmetic works on the surface: it cleanses, moisturizes, conditions, makes skin or hair look a certain way. It needs no ingredient-by-ingredient approval before going on sale, and it may not claim to act on a physiological process inside the skin.
The wording rules are stricter than people expect. A Japanese cosmetic may say it makes fine dryness lines less noticeable; it may not say it improves wrinkles. That distinction is why the middle tier exists at all.
医薬部外品 (iyakubugaihin) — quasi-drugs
The middle tier. To get here, a manufacturer takes a specific active with an approved dossier, uses it at an approved concentration, and applies to Japan's Ministry of Health, Labour and Welfare. If the application succeeds, the product may state one particular effect, in wording that was itself reviewed.
Nothing about how it is sold changes. Quasi-drugs sit on the same drugstore shelf as cosmetics, at the same prices, with no pharmacist involved. You have almost certainly bought several without noticing.
医薬品 (iyakuhin) — pharmaceuticals
Actual medicines, prescription or over-the-counter, sold under pharmacist supervision and sorted into risk classes. This is where a Japanese product goes when it genuinely treats a diagnosed condition — a steroid cream for eczema, an oral drug for acne.
The practical takeaway is a subtraction: if you want treatment for a diagnosed skin condition, the middle tier is not where it lives, no matter how clinical the packaging looks.
What the status actually means — and what it does not
Here is the sentence I most want you to take away. Quasi-drug approval attaches to one named active, at one approved concentration, for one specific claim. It is not an assessment of the product as a whole.
Everything else in the bottle — texture, hydrating base, preservative system, fragrance, whether it will sting your particular face — went through no review at all. The ministry looked at the active and at the sentence the brand wanted to print. So 医薬部外品 is not a quality mark. A well-formulated cosmetic can outperform a mediocre quasi-drug, and often does, because a good formula is mostly about the part approval never touches. I sell both and I will not pretend otherwise.
My own catalog demonstrates it. Tsubaki Oil Perfection is a plain cosmetic — its card says so in a dedicated field — and it publishes a complete ingredient list. POLA Wrinkle Shot Medical Serum N is a quasi-drug, and POLA publishes no full ingredient list online at all, directing buyers to a QR-code pamphlet instead. The regulated product is the less transparent one. Status and transparency are separate things.
The second thing approval usually does not mean is treatment. Most approved claims here are preventive. The card for Hada Labo Shirojun Medicated Whitening Lotion puts it plainly: the approved claim is prevention of spots and freckles caused by sun exposure, and it is not approved to remove pigmentation already there. Prevention is a useful thing to buy. It is just not the thing most people think they are buying.
The claim classes, and the Japanese words that signal them
A quasi-drug is never approved for "skincare" in general. It is approved inside a class. Once you know the classes, a Japanese shelf becomes legible.
| Japanese term | Reading / English | What the approval permits the product to say |
|---|---|---|
| 美白 | bihaku — brightening | Prevention of spots and freckles caused by sun exposure. Prevention, not removal. |
| シワ改善 | shiwa kaizen — wrinkle improvement | Improving the appearance of wrinkles. The newest and narrowest class, covered on its own in Japanese wrinkle-improvement skincare (薬用シワ改善). |
| ニキビ・肌荒れ防止 | nikibi / hada-are bōshi — acne and rough-skin prevention | Preventing breakouts and rough patches, not treating existing inflammatory acne. |
| 制汗・デオドラント | seikan / deodoranto — antiperspirant, deodorant | Reducing perspiration and body odor. |
| ふけ・かゆみ防止 | fuke / kayumi bōshi — dandruff and itch prevention | Flaking and scalp itch. The "medicated shampoo" class. |
| 薬用歯みがき | yakuyō hamigaki — medicated toothpaste | Cavity prevention, tartar control, gum care. |
| 育毛剤 / 染毛剤 | ikumōzai / senmōzai — hair tonics, hair dyes | Hair-growth tonics and permanent dyes sit here, not among cosmetics. |
| 入浴剤・薬用石けん | nyūyokuzai / yakuyō sekken — bath additives, medicated soaps | Bath preparations and antibacterial or anti-rough-skin soaps. |
Two things fall out of that table. First, how much of a Japanese drugstore sits quietly in the middle tier — your toothpaste and hair dye are likelier to be quasi-drugs than your face cream. Second, how narrow each permission is: an approval in the 美白 class says nothing about wrinkles, and one for wrinkles says nothing about pigmentation, even in the same bottle.
How to read the status off the box
Three signals, in order of reliability.
The framed declaration. On a quasi-drug, the characters 医薬部外品 are printed on the carton or back label, usually in a small ruled box near the ingredient list. It is a legal declaration rather than a design element, so it is always there and always in the same plain style.
The 薬用 prefix. 薬用 (yakuyō, "medicated") in front of a product name is the marketing half of the same thing — 薬用化粧水 is a medicated toner, 薬用歯みがき a medicated toothpaste. It usually travels with the status, and English listings render it as "Medicated".
The shape of the ingredient list. This is the tell that survives translation. A quasi-drug splits its ingredients into 有効成分 (yūkō seibun, active ingredients) and その他の成分 (sono-ta no seibun, everything else). A cosmetic prints one 全成分 (zenseibun) list in descending order of quantity. Two headed groups mean a quasi-drug.
The caution that matters most: the English word "Medicated" in a product title — on any website, sometimes including mine — translates a marketing name and is not proof of a status. If a listing does not state the status in words, the honest answer is that it is unstated, and I say exactly that below about one of my own products.
If you do not read Japanese, this is a solved problem. Photograph the back panel when your parcel arrives and send it to me; I will read the label and tell you what it says. Ask before ordering if you need to know first.
Five products from my own shelves
Everything below is described from the live product card, status included. Where a card does not state a status, I say so rather than filling the gap.
1. Hada Labo Shirojun Medicated Whitening Lotion — a textbook 美白 quasi-drug
Shirojun is Rohto's brightening toner, and its card gives you everything the system is supposed to give you: regulatory status, quasi-drug in Japan; actives, tranexamic acid and allantoin, both named as such; approved claim, prevention of spots and freckles caused by sun exposure.
Notice what that buys and what it does not. Two actives that were reviewed rather than chosen by a copywriter — but not removal of the mark on your cheekbone, which the card says outright the product is not approved to do, and not sun protection, since the same card notes there are no filters in the formula.
2. POLA Wrinkle Shot Medical Serum N — the reason the シワ改善 class exists
In 2016 POLA became the first company in Japan to win quasi-drug approval for a wrinkle-improvement claim, on an active it developed itself and named NEI-L1. Before that, no Japanese product could say more than that it made dryness lines less noticeable. That is what Wrinkle Shot bought with its approval.
The card is careful and so am I: the approval covers improving the appearance of wrinkles. It is not a filler and not a substitute for a medical procedure, and POLA's own data points to visible change from around eight weeks. If wrinkle care rather than the category is your actual question, read the dedicated guide to 薬用シワ改善 next, or the longer review of this serum.
3. Yuskin A Family Cream — a quasi-drug that has nothing to do with your face
Yuskin A is the yellow cream in half the households in Japan, and its card classifies it as a quasi-drug (医薬部外品) with four named actives: vitamin A as retinol palmitate, vitamin E as tocopherol acetate, vitamin B2 as riboflavin — which is why it is yellow — and glycyrrhizin from licorice. It breaks the mental picture most people have of the category: quasi-drugs are a hands, heels and elbows thing as often as a prestige skincare thing. The card is explicit that this one is made for body use and is not recommended as a daily facial cream for most skin types.
4. Tsubaki Oil Perfection — a cosmetic that says so
Tsubaki Oil Perfection earns its place for one line on its card: "Quasi-Drug Status: Cosmetic (not quasi-drug)". It also publishes a full ingredient list — camellia seed oil, two UV filters, the silicone film, the fragrance and the BHT. None of that required approval, and none of it is worse for the lack of one.
5. Skin Life Medicated Lotion — when the name and the card do not line up
This one is here as housekeeping. Skin Life Medicated Lotion carries "Medicated" in its title, and my card for it is short: an anti-acne lotion with anti-inflammatory components, hyaluronic acid, fruit acids and grapefruit extract, no oils, 150 ml. What the card does not do is state a regulatory status or name a single active. So I will not tell you it is a quasi-drug, and you should not assume it from the title — I would rather leave a status unstated than invent one. The fix is on my side, not yours: ask before you order and I will read the actual carton.
What happens when the parcel reaches your country
Short section, and deliberately careful, because this is where confident internet advice does the most damage. The Japanese status does not travel. 医薬部外品 is a classification created by Japanese law for products sold in Japan, and no other country recognizes it as such. As several of my own product cards note, outside Japan these same products are normally imported and sold as ordinary cosmetics. Your country will judge a product on what is in it and what is claimed for it, not on the Japanese tier printed on the box. Rules differ from country to country, they change, and they turn on the specific ingredient — so I am not going to make country-by-country legal statements from Kobe.
What I can tell you is what I do. Orders ship from Japan with a correct customs declaration and full tracking, in Japanese domestic packaging. Any duty or import VAT is set by your country and collected by your carrier on delivery. If you need to know whether a specific ingredient is permitted where you live, check your national rules first — or write to me and I will send the ingredient list from the actual carton so you have something concrete to check against.
Frequently asked questions
Is 医薬部外品 a medicine?
No. It is a separate legal category sitting between cosmetics and medicines in Japan. Quasi-drugs are sold on ordinary shop shelves with no pharmacist involved and are not authorized to treat a diagnosed condition. Japanese medicines are a different tier, 医薬品 (iyakuhin), sold under pharmacist supervision.
What does 薬用 (yakuyō) mean on a Japanese label?
薬用 translates as "medicated" and is the marketing prefix that usually accompanies quasi-drug status — 薬用化粧水 is a medicated toner. Treat it as a strong hint rather than proof. The reliable confirmation is the framed 医薬部外品 declaration near the ingredient list.
Does quasi-drug status mean a product is stronger or better?
No, and this is the most expensive misunderstanding in Japanese beauty. Approval covers one named active at one approved concentration for one specific claim. It says nothing about the rest of the formula, the texture or whether the product will suit your skin. A well-made cosmetic frequently outperforms a mediocre quasi-drug.
How do I tell whether a Japanese product is a quasi-drug or a cosmetic?
Look for 医薬部外品 printed in a small ruled box on the carton or back label, usually near the ingredients. Then check the ingredient list: a quasi-drug separates 有効成分 (active ingredients) from その他の成分 (other ingredients), while a cosmetic prints one 全成分 list in descending order of quantity. If neither signal is present, it is a cosmetic.
Does the Japanese status apply in my country?
No. The category exists under Japanese law for the Japanese market, and outside Japan these products are normally sold as ordinary cosmetics. Your country classifies an imported product by its composition and its claims, not by the Japanese tier on the box. Rules differ by country and change, so check your national rules for the specific ingredient.
Are quasi-drugs safe for sensitive skin?
Not automatically, and sometimes less so. Approval concerns the efficacy of an active, not the gentleness of a formula. The Hada Labo Gokujyun Medicated Skin Conditioner illustrates it: a quasi-drug with two approved anti-inflammatory actives that also contains ethanol, menthol and camphor, which its card says makes it unsuitable for a compromised barrier. Read the whole ingredient list, not the status.
Where to go next
If you take one thing from this guide, make it this: 医薬部外品 tells you a specific ingredient was approved for a specific sentence. It does not tell you the product is good, strong, safe for you, or worth the money. Those are still your questions to ask, and mine to answer honestly about anything I stock.
The classes people ask about most have their own guides, listed below — including Japanese brightening skincare, which covers Melano CC and its two named quasi-drug actives. To browse by category rather than by regulation, start with Japanese skincare, Japanese whitening skincare, Japanese toners and lotions or Japanese serum. Everything ships from Kobe in Japanese domestic packaging — framed declaration and all.
Related guides
- Japanese wrinkle-improvement skincare (薬用シワ改善) — one claim class, in depth
- Best Japanese whitening skincare — the 美白 class in practice
- Best Japanese toners 2026 — where quasi-drugs and cosmetics sit side by side
- Japanese retinol guide — an active that stayed on the cosmetic tier
Natalia Tsujimoto has been in Japan since 2002, sourcing Japanese cosmetics from Kobe for Tsujimoto Market since 2015. Every product described here is one she stocks and ships herself, and every regulatory status above is quoted from the live product card rather than from memory.