Cosmetics: HS Codes + MoCRA

The Modernization of Cosmetics Regulation Act (MoCRA), enacted December 2022 and progressively implemented through 2026, is the most significant overhaul of US cosmetics regulation since 1938. For importers of chapter 33 products (cosmetics, perfumery, skincare, hair care), MoCRA changes the compliance landscape entirely. The duty calculation is relatively simple (most lines at 0 percent MFN); the MoCRA compliance burden is the new dominant cost.

This guide covers the chapter 33 HS structure, the MoCRA framework, and the operational requirements for importers.

Chapter 33 structure

Chapter 33 has seven headings:

• 3301: essential oils, concretes, absolutes.
• 3302: mixtures of odoriferous substances used in industry (food, beverage, perfume).
• 3303: perfumes and toilet waters.
• 3304: beauty or make-up preparations, skin care.
• 3305: hair preparations.
• 3306: oral or dental hygiene preparations (toothpaste, mouthwash, floss).
• 3307: pre-shave, shaving, after-shave preparations, deodorants, bath preparations.

Most subheadings are 0 percent MFN. Perfumes (3303) carry 0.8 percent. Some toilet water and shaving cream subheadings carry small rates.

MoCRA: the six pillars

MoCRA imposes six major requirements on cosmetic manufacturers and importers:

1. Facility registration

Every facility that manufactures or processes cosmetics for the US market must register with FDA. The registration includes:

• Facility identifier (FEI), name, address.
• Contact information.
• Category of cosmetics produced.

For imports, the foreign manufacturing facility must be registered. The US importer of record is responsible for ensuring the registration exists.

Renewal: every two years.

2. Product listing

Each cosmetic product sold in the US must be listed with FDA. The listing includes:

• Facility identifier of the manufacturer.
• Product description, including HS code.
• Ingredient list.
• Trade name.
• Product category.

Updates: required within 60 days of any change.

3. Safety substantiation

Each cosmetic product must have safety substantiation on file at the responsible person's premises (the importer or the brand owner). The substantiation is a structured assessment of the product's safety for intended use, signed by a qualified scientist (typically with toxicology training).

4. Adverse event reporting

Serious adverse events must be reported to FDA within 15 business days of becoming aware. Records of all adverse event reports must be maintained for six years.

5. Good Manufacturing Practices (GMP)

FDA is developing cosmetics-specific GMP regulations expected to enter force in 2026. Manufacturers and importers will need to comply with documented quality systems, batch records, ingredient testing, and stability data.

6. Fragrance allergen labeling

Cosmetics containing fragrance allergens above specified thresholds must label them on the ingredient list. The list of regulated allergens parallels the EU regulation (Annex III to Regulation 1223/2009).

Worked example: 75,000 USD of Korean skincare into the US

A US importer brings in 75,000 USD of K-beauty skincare products from a Korean factory. HTS 3304.99.10 (skin care preparations). MFN 0 percent. Section 122 at 15 percent (not on exemption list).

Effective duty 15.5 percent. The MoCRA compliance:

• Korean facility registered with FDA.
• Each SKU listed with FDA.
• Safety substantiation per product on file at the US importer.
• Adverse event reporting process in place.
• Fragrance allergen labeling on each unit if applicable.

The compliance cost for a small importer can run 25,000 to 100,000 USD for setup, plus ongoing operational costs.

Worked example: 200,000 USD of French perfume

A US distributor imports 200,000 USD of French luxury perfume. HTS 3303.00.30 (perfumes and toilet waters). MFN 0 percent (or 0.8 percent on some subheadings). Section 122 at 15 percent.

The French perfumery industry has long-established MoCRA equivalents under EU cosmetics regulation; the transition is administrative rather than substantive.

Ingredient labeling

US cosmetic labeling requirements (separate from MoCRA but interlinked):

• Ingredient declaration: full ingredient list in descending order of predominance, using INCI (International Nomenclature of Cosmetic Ingredients) names.
• Quantity of contents: net weight or volume.
• Name and place of business: of the manufacturer, packer, or distributor.
• Warning statements: where required (eye products, aerosols, hair dyes).
• Country of origin: per 19 USC 1304.

For non-English-only markets, additional language requirements may apply (Quebec French, Spanish in some markets).

Color additives

US-specific rule: color additives in cosmetics must be on the FDA-approved list at 21 CFR Part 73 (exempt) or 21 CFR Part 74 (subject to certification). Foreign color formulations using colors not approved in the US must be reformulated for the US market.

Many natural colors (turmeric, beet juice, caramel) are exempt. Synthetic dyes (FD&C Red 40, FD&C Yellow 5, etc.) require batch certification by FDA. Lakes of these dyes have separate approval.

Banned and restricted ingredients

US-banned cosmetic ingredients include:

• Bithionol
• Chlorofluorocarbon propellants
• Chloroform
• Halogenated salicylanilides
• Hexachlorophene (with limited exceptions)
• Mercury compounds (with very limited exceptions for eye area)
• Methylene chloride
• Prohibited cattle materials (related to BSE)
• Vinyl chloride
• Zirconium-containing complexes (in aerosols)

The list is shorter than the EU restricted ingredients list (about 1,300 items in EU Annex II). Importers transitioning a globally-marketed product into the US should still verify against the US list.

Sun care products

Sunscreens are regulated as over-the-counter drugs in the US, not cosmetics. Sunscreens must conform to the FDA OTC Monograph 21 CFR Part 352. Active ingredients are limited to the approved monograph list (zinc oxide, titanium dioxide, avobenzone, octinoxate, oxybenzone, octisalate, octocrylene, homosalate, ensulizole, and a few others). Many sunscreen actives common in EU and Asian markets are not approved in the US.

For SPF/PA-claimed products: chapter 30 (drugs), not chapter 33 (cosmetics). The HS classification differs and the FDA regulatory burden is OTC-monograph rather than MoCRA.

How the calculator handles cosmetics

The LandedFees calculator for chapter 33 imports:

1. Classifies the HTS.
2. Applies 0 percent MFN where applicable.
3. Applies 15 percent Section 122.
4. Surfaces MoCRA regulatory hooks: facility registration, product listing, safety substantiation, fragrance allergen labeling.
5. Flags sun care products as OTC drug rather than cosmetic.
6. Notes color additive restrictions where applicable.

Related guides

• HS Code Lookup: How to Find Yours
• Pharma HS Codes and FDA Requirements
• Food and Beverage HS Codes: FDA and FSVP
• Chemistry HS Codes: Using CAS Numbers
• Calculate Import Duty: South Korea to USA
• Restricted Products: A Plain-English Guide

Try the LandedFees HS lookup tool for cosmetic classification.