The short version
- US law defines a cosmetic and a drug by intended use, and a product can be both.
- Every sunscreen is an over-the-counter drug in the US: Drug Facts panel, drug registration and listing.
- A product that is also a drug follows the drug rules instead of most of MoCRA.
- Claims matter as much as ingredients: treat, prevent, or change how the body works reads as a drug claim.
- Confirm where each product falls with a regulatory consultant before the first shipment.
Two definitions, decided by intended use
The Federal Food, Drug, and Cosmetic Act defines a cosmetic as an article intended to be applied to the body for cleansing, beautifying, promoting attractiveness or altering the appearance (21 U.S.C. 321(i)). It defines a drug to include an article intended for the diagnosis, cure, mitigation, treatment or prevention of disease, or intended to affect the structure or any function of the body (21 U.S.C. 321(g)(1)).
Both definitions turn on what the product is intended for, not on what it is called at home. A product can meet both, and MoCRA's cosmetics chapter treats a cosmetic that is also a drug separately (21 U.S.C. 364i).
Sources: 21 U.S.C. 321(g)(1), 321(i); 21 U.S.C. 364i (FD&C Act §613)
SPF: every sunscreen is a drug
A sun cream, a tinted moisturiser with SPF or a cushion compact sold with a sun protection factor is intended to prevent sunburn, so in the US it is an over-the-counter drug. It carries a Drug Facts panel in the format of 21 CFR 201.66 and the sunscreen labeling of 21 CFR 201.327, and the establishments that make it register and list under 21 CFR part 207.
Over-the-counter sunscreens follow monograph M020. In June 2026 FDA amended it for the first time in 20 years: final order OTC000039, issued 10 June 2026 and effective 9 August 2026, adds bemotrizinol at up to 6 percent. The same order authorizes solely DSM Nutritional Products LLC, or its licensees, assignees or successors in interest, to market sunscreens containing bemotrizinol for 18 months from 9 August 2026, so for now M020 does not open bemotrizinol to other sunscreen makers, Korean ones included.
Sources: 21 U.S.C. 321(g)(1), 321(i); 21 CFR 201.327, 201.66; 21 CFR 207.17, 207.69; 91 FR 35220 (FR Doc. 2026-11578); OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; FDA Expands Sunscreen Options for the First Time in 20 Years
Acne, whitening and dandruff: read the claim
Outside sunscreen, the words on the pack and in the listing usually decide. Hold each claim against the two definitions above:
| Claim on the product | Reads as, and why |
|---|---|
| Treats or prevents acne | Drug: treating or preventing a condition is the drug definition's wording. |
| Covers blemishes, makes skin look clearer | Cosmetic: altering the appearance is the cosmetic definition's wording. |
| Lightens skin by reducing melanin | Drug: acting on how the skin makes pigment affects a function of the body. |
| Brightens the look of dull skin | Cosmetic: a claim about appearance only. |
| Controls dandruff | Drug: dandruff treatment addresses a scalp condition. |
| Cleans hair and leaves it shiny | Cosmetic: cleansing and beautifying. |
Sources: 21 U.S.C. 321(g)(1), 321(i); Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?); OTC Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use; OTC Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use; 21 U.S.C. 355h(a)(4) (FD&C Act §505G(a)(4)); FDA works to protect consumers from potentially harmful OTC skin lightening products
What changes when a product is a drug
- Labeling — a Drug Facts panel in the format of 21 CFR 201.66, not only the cosmetic label.
- Registration and listing — the establishments that make it register and list the drug under 21 CFR part 207.
- MoCRA mostly steps aside — a cosmetic that is also a drug is exempt from MoCRA's adverse-event, manufacturing-practice, registration and listing, safety-substantiation, label-contact, records and recall provisions (21 U.S.C. 364i(a)).
- The factory's other products — a facility that also makes ordinary cosmetics still registers under MoCRA for them (21 U.S.C. 364i(b)).
The MoCRA side is in MoCRA for K-beauty importers.
Sources: 21 CFR 201.327, 201.66; 21 CFR 207.17, 207.69; 21 U.S.C. 364i (FD&C Act §613)
Why it matters at the border
Under section 801(a) of the Act, FDA can refuse admission to an imported product that appears adulterated or misbranded. A drug shipped with only a cosmetic label, or from an establishment that has not registered and listed it, is exposed on both counts.
Sources: 21 U.S.C. 381(a) (FD&C Act §801(a)); Cosmetic Overview for Imported Products
Where Senda fits
Senda is building a cosmetic-or-drug check for each order line: it reads the description, the claims and the ingredient list, shows which words or ingredients point to the drug rules, and links each reason to its source. It flags; it does not decide. Senda files nothing with FDA, and a regulatory consultant confirms where each product falls.