A skincare product becomes a drug when it is intended to treat, cure, mitigate or prevent a disease or to affect the structure or function of the body, and regulators read that intent from your claims on the label, website, ads and social posts, and sometimes from the ingredients. In the US, acne treatments, dandruff shampoos, antiperspirants, skin protectants and sunscreens are OTC drugs that must follow an FDA monograph, hair regrowth products need an approved drug application, and OTC skin lighteners such as hydroquinone can no longer be sold without one. A product stays a cosmetic when its claims stay on appearance, cleansing and feel, for example "helps skin look clearer" instead of "treats acne".
How the line is drawn
US law defines the two categories by purpose. A cosmetic is meant to be applied to the body for cleansing, beautifying, promoting attractiveness or altering the appearance. A drug is meant for the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. The same cream can be either, depending on what it is "intended" to do.
FDA reads intended use from three things:
- Your claims, everywhere
The label, the box, the website, Amazon and TikTok Shop listings, ads, emails, social posts and influencer content you direct. A cosmetic label with a drug claim on Instagram is a drug in FDA's eyes.
- Consumer perception
What buyers understand the product to do, which can come from the product's reputation or how it is sold, for example in an "acne treatment" store category.
- Ingredients with a known therapeutic use
An ingredient widely known as a drug active can signal drug intent, as fluoride does in toothpaste.
Some products are both. FDA's own examples: an anti-dandruff shampoo cleans hair (cosmetic) and treats dandruff (drug); a deodorant that is also an antiperspirant; a moisturizer or makeup with sun protection claims. A product that is both must meet the cosmetic rules and the drug rules. "Cosmeceutical" has no meaning under US law: there is no middle category.
Most other markets use the same logic with their own words: Canada looks at "representation" and composition, the EU at the presentation and function of the product, Japan and Korea have formal in-between classes (quasi-drugs, functional cosmetics), and China has "special cosmetics" that need registration.
Cosmetic vs drug word list
These are typical readings, not a safe list: context, images and the overall impression matter. Use the cosmetic column as a starting point and keep your evidence for every claim. The full claim-by-claim guide with substantiation is in what skincare claims you can make.
| Topic | Usually cosmetic | Usually a drug claim (US and most markets) |
|---|---|---|
| Acne | For blemish-prone skin; helps skin look clearer; cleanses pores; reduces the look of shine | Treats, clears or prevents acne; kills acne bacteria; heals pimples; reduces breakouts as a treatment |
| Wrinkles and aging | Reduces the look of fine lines; skin looks smoother and firmer | Removes wrinkles; rebuilds or boosts collagen; repairs skin at the cellular level; reverses aging |
| Spots and tone | Brightens the look of skin; evens the look of skin tone | Lightens or bleaches skin; removes dark spots or melasma; inhibits melanin |
| Irritation | Soothes the feeling of dry skin; comforts; calms the look of redness | Anti-inflammatory; treats eczema, dermatitis, rosacea or psoriasis; relieves itching from a condition |
| Barrier | Supports a healthy-looking skin barrier; locks in moisture | Heals damaged skin; repairs wounds, cuts or burns |
| Scalp and hair | Cleanses flakes away; hair looks fuller and thicker; for a healthy-looking scalp | Treats dandruff (an OTC drug in the US); stops hair loss; regrows hair; treats alopecia |
| Sweat and odor | Deodorant; keeps you smelling fresh | Reduces sweat or wetness (antiperspirant) |
| Sun | No sun claim without a sunscreen route | SPF; prevents sunburn; protects from UV (a drug in the US and Canada) |
| Germs | Cleanses | Antibacterial; kills 99.9% of germs; antiseptic |
| Body | Skin looks smoother; firming look | Reduces cellulite or fat; slims; increases circulation |
Words to keep away from cosmetic copy in the US: treat, cure, heal, prevent (a disease), therapy, medical, clinical strength (when it implies a drug), anti-inflammatory, antibacterial, eczema, psoriasis, rosacea, dermatitis, acne (as a target of treatment), melasma, alopecia, regrow, collagen production, cell regeneration, "prescription strength".
US OTC drug categories that touch skincare
An OTC drug can be sold without an approved application only if it follows an FDA monograph: listed active ingredients at listed strengths, set label text and set tests. Since the CARES Act of 2020 monographs are published as administrative orders on FDA's OTC Monographs@FDA site, each with an M number.
| Use | Monograph | Active ingredients (examples, with strengths) |
|---|---|---|
| Acne | M006 Topical acne drug products | Benzoyl peroxide 2.5 to 10%; salicylic acid 0.5 to 2%; sulfur 3 to 10%; resorcinol 2% or resorcinol monoacetate 3%, only combined with sulfur 3 to 8% |
| Dandruff, seborrheic dermatitis, psoriasis | M032 | Pyrithione zinc 0.3 to 2% (rinse-off) or 0.1 to 0.25% (leave-on); salicylic acid 1.8 to 3%; selenium sulfide 1% (micronized 0.6%); sulfur 2 to 5%; coal tar 0.5 to 5% |
| Antiperspirant | M019 | Aluminum salts such as aluminum chlorohydrate and aluminum zirconium compounds |
| Skin protectant | M016 | Allantoin, colloidal oatmeal, dimethicone, glycerin, petrolatum, zinc oxide and others |
| Sunscreen | M020 | Listed UV filters only; see sunscreen regulation |
| External analgesic | M017 | Pain, itch relief actives (outside most skincare lines) |
| Wart remover | M028 | Salicylic acid |
| Hair regrowth | None | No monograph: OTC hair growers are not GRASE (21 CFR 310.527); minoxidil is sold under approved drug applications |
| Skin lightening | None | OTC skin lighteners need an approved application since September 2020 |
Strengths above come from the monograph texts on OTC Monographs@FDA as of October 2026. Each monograph also fixes the statement of identity, the indications, the warnings and the directions word for word.
Acne: the most common line to cross
Under monograph M006 an acne drug is labeled as an "acne medication" or "acne treatment" with a Drug Facts panel, its active ingredient and percentage, and warnings such as using one topical acne medication at a time to avoid dryness. A benzoyl peroxide product also carries specific warnings about irritation and bleaching of hair and fabric.
Acids in cosmetics have their own limits and labeling advice; see AHA, BHA and PHA acids. For cleansers we make, see private label cleansers.
Dandruff and scalp care
"Anti-dandruff" is a drug claim in the US: the product follows monograph M032, uses one of its actives (for example pyrithione zinc or salicylic acid) and carries Drug Facts. A shampoo or scalp serum that "cleanses away flakes" or "soothes the feeling of a dry scalp" without treating dandruff is a cosmetic. The EU usually treats anti-dandruff shampoos as cosmetics, but zinc pyrithione has been banned in EU cosmetics since March 2022, so a US dandruff formula and an EU formula differ. Scalp products we make are on private label hair care.
Hair regrowth and hair loss
In the US there is no OTC monograph for hair growth. FDA's rule at 21 CFR 310.527 says any OTC product labeled, represented or promoted for external use as a hair grower or for hair loss prevention is a new drug that needs approval. Topical minoxidil, the familiar OTC hair regrowth active, is sold under approved new drug applications, not a monograph. So for a cosmetic scalp serum, "hair looks thicker and fuller", "strengthens hair against breakage" and "for a healthy-looking scalp" are the claims to aim for; "stops hair loss", "regrows hair" and "DHT blocker" are drug claims.
Other markets differ: hair loss symptom relief is a functional cosmetic class in Korea and an anti-hair loss special cosmetic in China, both needing pre-market review.
Skin lightening and dark spots
Under the CARES Act, OTC skin lightening products containing hydroquinone are unapproved new drugs. FDA says that from September 23, 2020, makers and distributors of OTC skin lighteners without FDA approval had to remove them from the market, and in April 2022 it sent warning letters to 12 companies still selling them. In practice, "skin lightening", "bleaching" or "removes dark spots and melasma" puts a US product into drug territory.
Cosmetic brightening is fine when the claims stay on appearance: "brightens the look of skin", "evens the look of skin tone", "reduces the look of dark spots". Niacinamide, tranexamic acid, vitamin C and licorice root are common in such products; see niacinamide, tranexamic acid and brightening and vitamin C forms. "Whitening" is a regulated functional claim in Korea, a quasi-drug claim in Japan and a special cosmetic in China, and it is a sensitive word on ad platforms.
Antiperspirants, skin protectants and sunscreen
- Antiperspirant: "reduces underarm wetness" is a drug claim (M019). A deodorant that only fights odor is a cosmetic.
- Skin protectant: "temporarily protects and helps relieve chapped or cracked skin" with a listed active such as dimethicone or petrolatum at the monograph strength is a drug claim under M016. Lip balms and hand creams often slip into this by copy alone.
- Sunscreen: any SPF or sunburn claim makes the product a drug in the US, including tinted moisturizers and cushions. It needs the full OTC route in our sunscreen regulation guide.
What being a drug means in the US
If your product is an OTC drug, the cosmetic route under MoCRA no longer applies to it. Instead:
- Monograph compliance
Only listed actives at listed strengths, permitted combinations and the exact label text. Anything else needs an approved new drug application, which is a clinical development project.
- Drug Facts label
The standard panel under 21 CFR 201.66, with the active ingredient percentage, purpose, uses, warnings, directions and inactive ingredients.
- Drug establishment registration and listing
The factory registers as a drug establishment and lists the product, which gets a National Drug Code (NDC). A foreign site names a US agent.
- Drug GMP
Production and testing to 21 CFR parts 210 and 211, including assay of the active in each batch and stability programs.
- User fees and reporting
OTC monograph facilities pay a yearly OMUFA fee ($47,891 per facility for fiscal year 2027, $31,927 for a contract manufacturing facility), and drug adverse event rules apply.
For a cosmetic you instead follow MoCRA: facility registration, product listing, safety substantiation and serious adverse event reporting. See the MoCRA compliance guide and MoCRA registration for skincare brands.
Canada, EU, UK, Japan, Korea and China
| Market | The in-between class | How it is decided | Examples that are not plain cosmetics |
|---|---|---|---|
| Canada | Natural health product (NPN) or non-prescription drug (DIN) | Health Canada's cosmetic-drug interface guidance: representation (claims, explicit or implied) and composition | Sunscreens, acne treatments, anti-dandruff with drug actives, antiperspirants, skin whiteners |
| EU and UK | Medicinal product (or another regime, such as a biocide or medical device) | Case by case by national authorities, guided by the Commission's borderline products manual | Products claiming to treat or prevent disease; hair regrowth or eczema treatment claims |
| Japan | Quasi-drug (medicated cosmetic) | Pre-market approval under the PMD Act from MHLW or the prefecture | Whitening by melanin suppression, acne prevention, anti-dandruff, hair growth, medicated antiperspirant |
| South Korea | Functional cosmetic | MFDS review, or a report when ingredients match MFDS notices, by the responsible seller | Whitening aid, wrinkle improvement, UV protection, acne alleviation, atopic-prone dryness relief, stretch mark redness, hair loss symptom relief, hair dye, hair removal |
| China | Special cosmetic | NMPA registration before production or import (CSAR Article 16 and 17) | Hair dye, perm, freckle removal and whitening, sunscreen, anti-hair loss, and any new efficacy claim |
Canada. Personal care products fall under one of three sets of rules under the Food and Drugs Act: the Cosmetic Regulations, the Food and Drug Regulations or the Natural Health Products Regulations. Health Canada looks at how the product is represented (therapeutic claims, dose-like directions) and what it contains. A therapeutic claim moves the product out of cosmetics, and a product classed as a drug stays one regardless of how it was sold before. See our Canada guide.
EU and UK. The EU decides borderline products case by case, using the Commission's manual on the scope of the Cosmetics Regulation. A product presented as treating or preventing disease is a medicinal product. Cosmetic claims must also meet Regulation (EU) 655/2013. See our EU guide and UK guide.
Japan. Cosmetics may only make claims from the official list of cosmetic efficacy claims (such as keeping skin moist or preventing dryness). Claims beyond it, such as preventing spots and freckles from sunburn by suppressing melanin, make the product a quasi-drug that needs approval before shipment. See our Japan guide.
Korea. A functional cosmetic must be reported to or reviewed by MFDS before sale, by the brand acting as the Korean responsible seller. The review route takes about 60 days. See our Korea guide.
China. Under the Cosmetic Supervision and Administration Regulation (CSAR), special cosmetics are registered with NMPA before they are produced or imported, while general cosmetics are filed. An overseas brand appoints a legal entity in China to register or file and to help with adverse reaction monitoring and recalls. Products registered under the old categories of hair growth, hair removal, breast care, slimming and deodorant had a five-year transition from January 1, 2021. See our China guide.
Keep a product cosmetic, step by step
- Decide the route per market first
Before the brief, decide for each market whether the product is a cosmetic or a drug (or functional cosmetic, quasi-drug or special cosmetic). It changes the formula, the factory, the label and the budget.
- Write the claim list before the formula
List every claim you want, then sort it with the word list above. Move drug claims out, or plan the drug route for them.
- Check the product name
"Acne Serum", "Eczema Cream" or "Hair Regrowth Tonic" is a claim in itself. "Clarifying Serum" or "Scalp Serum" is not.
- Audit every channel
Label, box, website, marketplace listings, A+ content, ads, emails, influencer briefs, hashtags and reviews you repost. One drug claim anywhere is enough.
- Brief creators in writing
Give influencers and UGC creators a list of allowed and banned phrases. See FTC and ASA advertising rules and reviews and testimonials.
- Keep evidence for cosmetic claims
Even appearance claims need support. Measured claims ("reduces the look of fine lines in 4 weeks") need an efficacy test; see efficacy claims testing.
- Recheck when you change markets
A claim that is cosmetic in the EU can be a drug claim in the US or a functional claim in Korea.
- Thinking only the label counts. FDA and Health Canada read your website, ads and social posts too.
- Calling a 2% salicylic acid serum an "acne treatment" without following monograph M006 and the drug rules.
- Selling "anti-dandruff" shampoo in the US as a cosmetic, or an EU dandruff formula with zinc pyrithione.
- "Hair growth" or "stops hair loss" on a scalp serum. In the US that is a new drug under 21 CFR 310.527.
- "Skin lightening" or "removes melasma" copy on a US brightening serum.
- Adding SPF to a moisturizer as a small extra. In the US and Canada it turns the product into a drug or natural health product.
- Using "cosmeceutical" or "medical grade" as if it were a category. It is not, and it suggests drug use.
- Reposting customer reviews that say "cured my eczema". Content you choose to share can become your claim.
- Route decided per market: cosmetic, OTC drug, NHP, quasi-drug, functional or special cosmetic
- Claim list written and sorted against the cosmetic vs drug word list
- Product name free of disease or treatment words
- No treat, cure, heal, prevent, eczema, acne treatment, regrow or lighten in cosmetic copy
- No SPF or sun claims unless the sunscreen route is planned
- Website, marketplace listings, ads and emails checked against the same list
- Influencer and UGC brief with allowed and banned phrases signed
- Reposted reviews and testimonials screened for drug claims
- Evidence on file for every cosmetic performance claim
- US drug products: monograph, Drug Facts, drug registration, NDC and drug GMP planned
- EU formula checked for ingredients banned in cosmetics, such as zinc pyrithione
- Claims rechecked before entering each new market
How KoreanOEM helps
We are a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea. Because we know what is in your product, we can check your claims against the formula and the market before anything is printed.
- Cosmetic versions of the products people ask about most: clarifying serums and BHA cleansers for blemish-prone skin, brightening serums with niacinamide or tranexamic acid, barrier creams, scalp serums and shampoos, with claims written to stay cosmetic. A 30 mL serum starts from about USD
3.40 at500 units; toners from about USD2.89 at1,000 units; scalp serums and shampoos from 1,000 units. - Sunscreen: SPF 50+ PA++++ textures from 10,000 units; a US sunscreen is an OTC drug and is quoted case by case.
- OTC drug versions for the US (an acne treatment or dandruff shampoo with Drug Facts) and registrations such as Korean functional cosmetics or Chinese special cosmetics: tell us what you need; our team checks with the lab or partner and comes back before anything is promised.
- A label proof check against your market's rules, including claims that would make the product a drug. See label proof check and ingredient lists, PAO and claims.
- Tests behind your claims: patch test from USD 1,000, HRIPT from USD 3,000 (50 people) or USD 5,500 (100 people); efficacy tests quoted per product. See product testing and fees.
Frequently asked questions
What makes a skincare product a drug instead of a cosmetic?
Is a salicylic acid cleanser a drug?
Is anti-dandruff shampoo a cosmetic or a drug?
Can a cosmetic claim to stop hair loss or regrow hair?
Can I sell a hydroquinone cream over the counter in the US?
Is "brightening" a drug claim?
What is a quasi-drug in Japan?
What is a functional cosmetic in Korea?
Is "cosmeceutical" a legal category?
Sources
- FDA: Is it a cosmetic, a drug, or both? (Or is it soap?)
- 21 U.S.C. 321 (FD&C Act section 201): definitions of drug and cosmetic
- FDA: OTC Monographs@FDA, monograph list (M006, M016, M019, M020, M032)
- FDA: OTC Monograph M006, topical acne drug products (PDF)
- FDA: OTC Monograph M032, dandruff, seborrheic dermatitis and psoriasis (PDF)
- eCFR: 21 CFR 310.527, OTC hair growers and hair loss prevention products
- FDA: FDA works to protect consumers from potentially harmful OTC skin lightening products
- eCFR: 21 CFR 201.66, Drug Facts labeling
- Health Canada: Classification of products at the cosmetic-drug interface
- European Commission: Borderline products and the borderline manual
- EUR-Lex: Regulation (EU) No 655/2013, common criteria for cosmetic claims
- PMDA: Manufacturing and marketing procedures for quasi-drugs (provisional English translation, PDF)
- MFDS: Functional cosmetics and their evaluation
- People's Daily: Full text of China's Cosmetic Supervision and Administration Regulation (Chinese)
- Federal Register: OTC Monograph Drug User Fee Rates for Fiscal Year 2027
Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.