US label requirements for Korean cosmetics: a pre-shipment list

The adverse-event contact is MoCRA's addition: "a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports" (21 U.S.C. 364e(a)). It took effect on 29 December 2024. "Domestic" qualifies only the address and phone number, so a website works.

On net quantity, the Fair Packaging and Labeling Act (15 U.S.C. 1453(a)(2)) calls for both US units and metric. FDA's cosmetic rule (21 CFR 701.13) still requires ounces or fluid ounces and permits metric alongside. Print both on the principal display panel, for example "Net wt. 1.76 oz (50 g)" or "1.69 fl oz (50 mL)".

• The identity statement — a brand name or a Korean product type is not always a statement of what the product is in English.
• The responsible company — a Korean label names the Korean manufacturer; the US label names whichever manufacturer, packer or distributor takes that role, and carries the US adverse-event contact.
• Origin marking — an overlabel must not hide the country of origin.

Language. Every statement US law requires on the label must be in English (21 CFR 701.2(b)(1)). If the label carries any Korean, or any other foreign language, every required statement must also appear in that language (701.2(b)(2)).

Ingredients. List ingredients in descending order of predominance (701.3(a)). Alternatively, list ingredients above 1 percent in descending order, then ingredients at 1 percent or less in any order, then colour additives in any order (701.3(f)). Name a colour by its US name, such as "FD&C Yellow No. 5" or "Yellow 5". A CI number may follow in brackets ("Yellow 5 (CI 19140)"), but it can't replace the name.

Warnings. Part 740 has no warning aimed at ordinary leave-on skincare or make-up. A warning is required for an aerosol (740.11), a foaming bath product not labelled adults-only (740.17), a feminine deodorant spray (740.12), a tanning product or self-tanner without sunscreen (740.19), or any product whose safety hasn't been substantiated (740.10). Warnings go in bold on a contrasting background, at least 1/16 inch high (740.2). A pump mist isn't "self-pressurized" and doesn't trigger 740.11.

MoCRA directs FDA to make a rule requiring fragrance allergens to be disclosed on the label (21 U.S.C. 364e(b)). As of 30 September 2026 FDA had not proposed that rule, so there is no fragrance-allergen labeling requirement to meet yet.

A product that is also a drug — every sunscreen, for a start — is labelled under the drug rules: a Drug Facts panel in the format of 21 CFR 201.66, and for sunscreen the labeling of 21 CFR 201.327. Whether a product is one is in Cosmetic or drug in the US?.

A cosmetic whose label does not meet these rules is misbranded, and under section 801(a) of the Act FDA can refuse admission to an import that appears misbranded. Fixing a label in Korea, before packing, is the cheap place to do it.

Senda is building a US label pre-check on the cosmetics shipment: the items above as a checklist, each marked with the document or field on file that shows it, or left open. It is a checklist, not a label review. Senda files nothing with FDA, and your consultant signs off the label.