Cosmetics and skin-care HTSUS 330410-330499: U.S. import duties and FDA rules 2026

Classification conclusion and import answer

Conditional conclusion: non-medicated beauty, make-up and skin-care preparations are generally classified in heading 3304, but no single ten-digit number covers the full category. Lip preparations are 3304.10.0000; eye preparations 3304.20.0000; manicure/pedicure preparations 3304.30.0000; powders 3304.91.0010 or 3304.91.0050; petroleum jelly put up for retail skin care 3304.99.1000; and other preparations commonly 3304.99.5000. Classification does not establish FDA status. A cosmetic may be imported only when it is safe, properly labeled and compliant with the Federal Food, Drug, and Cosmetic Act and MoCRA; sunscreen and therapeutic acne/skin claims can make the product an OTC drug or a cosmetic-drug combination.

How to select the HTSUS 3304 provision

GRI 1 applies the heading text and Chapter 33 notes; GRI 6 selects the U.S. statistical line. Establish the formula, physical form, intended body area, claims, retail presentation and whether the preparation is medicated. Perfume belongs in 3303, hair preparations in 3305, oral care in 3306 and deodorants, bath or depilatory preparations may be 3307. Cleansing products can move to 3401. Impregnated wipes and mixed retail kits require separate analysis under the legal notes and GRI 3(b). A foreign supplier's HS number is evidence, not a binding U.S. classification.

Base duty and China Section 301

The current HTSUS Column 1 General rate for the principal 3304 lines listed above is Free; Column 2 is generally 75%. Free does not mean no import charges: merchandise processing fee applies and harbor maintenance fee can apply to ocean entries. Chinese-origin 33041000, 33042000, 33043000, 33049100, 33049910 and 33049950 are covered by the additional 25% Section 301 List 3 duty unless a current exclusion or Chapter 99 rule applies. Report the proper 9903 provision and verify entry-date treatment in the USITC HTSUS and USTR Section 301 search. AD/CVD and sanctions screening remains product-, origin- and producer-specific.

Cosmetic or drug: the decisive FDA question

FDA classification turns on intended use shown by labels, website, advertising, consumer perception and ingredients. A preparation used only to cleanse or beautify is a cosmetic. Claims to treat acne, eczema, pigmentation disease or to affect body structure/function can create a drug. Sunscreen is an OTC drug in the United States, even though many customs systems place it in heading 3304; it must meet the applicable OTC monograph/order, active-ingredient, Drug Facts, establishment registration and drug-listing rules. Review FDA's cosmetic-or-drug guide before fixing the regulatory route.

MoCRA registration and product listing

MoCRA requires covered facilities that manufacture or process cosmetics distributed in the United States to register with FDA and renew biennially, subject to statutory exemptions. The responsible person must list each marketed cosmetic and update the listing, maintain safety substantiation, report serious adverse events within the statutory period and retain records. A foreign facility must name a U.S. agent. Registration/listing is not FDA approval and no registration certificate should be marketed as approval. Confirm identifiers and current filing instructions on FDA's Cosmetic Direct and registration page.

Ingredients, color additives and safety

Cosmetics must not be adulterated. Maintain formula, specifications, microbiological/heavy-metal controls, stability, packaging compatibility and qualified safety evidence. Color additives must be approved for the exact intended use, body area and restrictions; some require FDA batch certification. Eye-area and lip use are especially sensitive. Products containing prohibited cattle material, contaminated talc, mercury, unsafe preservatives or unapproved colors can be detained. The importer should connect each SKU and lot to the actual manufacturer, formulation version, COA and traceable distribution record.

Labeling, claims and sunscreen

The principal display panel and information panel must accurately state identity, net quantity, ingredient declaration in descending order, responsible business name/address and required warnings in English. Imported articles also need country-of-origin marking under 19 U.S.C. 1304 and 19 CFR Part 134. Claims must be truthful and not misleading under FDA and FTC law. Sunscreens need compliant Drug Facts and active ingredients; cosmetic SPF marketing cannot bypass the OTC drug regime. Use FDA's Cosmetic Labeling Guide, not a foreign-market label template.

Entry file and customs description

The entry file should include invoice, packing list, transport document, customs value, origin support, formula/INCI list, product label, manufacturer and responsible-person details, MoCRA facility/product identifiers where required, and drug data for sunscreen or dual-status products. A useful description is: “Non-medicated facial moisturizing cream, retail jars, 50 ml, no sunscreen or therapeutic claims, HTSUS 3304.99.5000, country of origin...”. Do not declare only “cosmetics.” Provide FDA product codes and Affirmation of Compliance data accurately when requested; FDA may screen the entry through PREDICT and examine or sample the goods.

Enforcement and risk controls

Common failures are treating base duty Free as landed duty, omitting the China Chapter 99 line, using a cosmetic label for sunscreen, relying on registration as approval, unapproved colors, and claims that convert a product to a drug. FDA may detain without physical examination, refuse admission, request relabeling/destruction/export or pursue recall and enforcement. CBP can separately assess duty, marking and origin penalties. Before shipment, run a product-by-product classification and FDA-status matrix, validate the label and claims, screen Section 301/AD-CVD/UFLPA where relevant and retain an auditable safety file.

Official sources

Primary sources checked 12 September 2026: USITC HTSUS, FDA Importing Cosmetics, FDA Cosmetics Importers, MoCRA registration and listing, and FDA sunscreen guidance. Recheck the HTSUS revision, FDA implementation status and Chapter 99 on the entry date.

Limits of this guidance

This is conditional general guidance, not a CBP ruling, FDA admissibility decision or legal opinion for a specific SKU. A final result requires the complete quantitative formula, label and advertising claims, intended use, packaging, origin, manufacturer, value and entry date. The importer of record and responsible person retain responsibility for classification, value, origin, FDA status, safety, labeling, listing, adverse-event reporting and distribution.

Editorial note

Prepared by the Global HS Code Checker Editorial Team for customs-classification, tariff and import-policy research. The correct code and applicable measures may change with the merchandise's actual characteristics, jurisdiction, entry date and supporting record. Verify the current tariff, governing measures and competent customs authority before filing an entry. A reviewer is identified only after a named expert has completed the review.