By Tam Nguyen | CEO, GOL Solution | 24+ years in international trade & cross-border logistics

Last Updated: October 2026

To sell cosmetics on Amazon US, you need four things in place: FDA requirements under MoCRA (facility registration, product listing, safety records and adverse event reporting), an FDA-compliant label, listing claims that hold up under FTC advertising law, and a California Proposition 65 warning wherever a listed chemical calls for one. Amazon then adds its own rules on top, from required label images and claim limits to third-party testing for skin-lightening products.

This guide puts the full stack in one place for brands from Asia and other regions, using Amazon’s own policy pages, the primary FDA, FTC and California sources, and three label cases from our own work.

Who this applies to	Brands and US sellers listing imported cosmetics (skin care, hair care, makeup, fragrance) on Amazon US.
What is required	MoCRA facility registration (by the factory) and product listing (by the brand named on the label), an FDA-compliant label, FTC-compliant claims, a Prop 65 warning where needed, and Amazon’s Cosmetics, skin, and hair care policy.
Timeline	Label review: 5 to 7 days per round, usually 3 rounds, about 30 days in total. Product listing and Facility registration: within 10-30 days, concurrently with label review.
Typical cost (GOL service fees)	$800 for a brand whose factory is already FDA-registered (1 product listing plus a full FDA, FTC and Prop 65 label review). $2,250 if your own factory also needs registration and a US Agent.

Is your product a cosmetic or an OTC drug?

It depends on intended use: a product is a cosmetic if it is meant for “cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, section 201(i)), and a drug if it is meant to treat or prevent disease or “to affect the structure or any function of the body” (section 201(g)(1)). A product can also be both.

FDA works out intended use from the claims on your label, in advertising, on the internet and in other promotional material, which includes your Amazon listing. It also looks at consumer perception and at ingredients with a well-known therapeutic use (FDA: Is it a cosmetic, a drug, or both?).

• A claim to restore hair growth makes a product a drug.
• Anti-dandruff shampoo, and moisturizers or makeup with sun-protection claims, are both cosmetics and drugs.
• Amazon applies the same split: products that are both, such as anti-dandruff shampoo, sunscreen moisturizers and foundations, and antiperspirant deodorant, must meet the requirements for both product types (Amazon policy).

What does MoCRA require before you list on Amazon?

MoCRA splits the work between two parties: the factory that makes the product registers its facility, and the responsible person, meaning the manufacturer, packer or distributor whose name appears on the label, lists each product and carries the safety, adverse event and label duties (FDA MoCRA page; FDA registration and listing guidance, December 2024).

Obligation	Who	When
Facility registration (Cosmetics Direct or Form FDA 5066)	The owner or operator of the facility that manufactures or processes the product, including foreign facilities. A foreign facility must name a US agent.	Within 60 days of starting manufacturing. Renew every 2 years.
Product listing (Cosmetics Direct or Form FDA 5067)	The responsible person	Within 120 days of first marketing the product. Update every year. The listing must include the registration number of each facility where the product is made.
Safety substantiation	The responsible person	Keep records that show adequate substantiation of safety for as long as the product is sold.
Serious adverse event reports	The responsible person	Within 15 business days of receiving a report, with a copy of the label. Keep records for 6 years, or 3 years for a qualifying small business.
Adverse event contact on the label	The responsible person	On every label: a domestic address, a domestic phone number.

Sources: 21 U.S.C. 364, 364a, 364c, 364d and 364e (FD&C Act as amended by MoCRA), and FDA guidance on registration and listing (December 2024).

Two details trip up many sellers. First, a site that only labels, relabels, packs, repacks, holds or distributes cosmetics is not a “facility” under MoCRA, so a brand owner or importer that does not manufacture does not register a facility. Second, FDA does not issue registration certificates: it uses the facility’s FEI number as the registration number, and it does not approve cosmetics before they go on sale.

Small businesses. A business whose average gross annual US sales of cosmetic products over the previous 3 years are under $1,000,000, adjusted for inflation, is exempt from facility registration and product listing. The exemption does not cover products that regularly contact the eye area, injected products, products for internal use, or products that alter appearance for more than 24 hours. Safety substantiation, labeling and adverse event reporting still apply (FDA small business fact sheet).

What must your label show under FDA rules?

Your label needs an identity statement, net contents in US units, the name and place of business of the firm marketing the product, an ingredient list in descending order of predominance, any required warnings, and, since MoCRA, a contact for adverse event reports (FDA labeling summary).

Label element	What FDA requires	Rule
Identity statement	The name of the product and its nature or use, on the principal display panel.	21 CFR 701
Net quantity of contents	Ounces or fluid ounces (US customary units). Metric may be added.	21 CFR 701
Name and place of business	The firm marketing the product, with street address, city, state and ZIP code.	21 CFR 701.12
Ingredient declaration	All ingredients, in descending order of predominance.	21 CFR 701.3
Warnings	Warnings and directions for safe use where misuse could be hazardous, plus product-specific warnings such as aerosols.	21 CFR 740
Adverse event contact	Domestic address, domestic phone number, or electronic contact information such as a website.	21 U.S.C. 364e(a)
Professional use only	A prominent statement that the product is to be used only by licensed professionals.	21 U.S.C. 364e(c)

MoCRA also requires fragrance allergens to be named on the label once FDA sets the list by regulation. Amazon already asks to see “warnings and fragrance allergens” in its label images, so check FDA’s MoCRA page for the current status before you print.

Coal-tar hair dyes have their own rule. Under FD&C Act section 601(a), the label must carry this caution statement, with adequate directions for a skin test (FDA hair dyes page):

“Caution – This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”

Which claims on your Amazon listing fall under the FTC instead of FDA?

FDA governs labeling and decides, from claims anywhere including your Amazon listing, whether your product is a cosmetic or a drug. The FTC governs advertising, which on Amazon covers your title, bullet points, images and description, and it requires objective claims to be truthful and supported by evidence.

The claims we see most often

• “Natural” and “100% natural”. In 2016 the FTC acted against five companies that called lotions, shampoo and sunscreen “all natural” or “100% natural” online, including on Walmart.com and Walgreens.com, when the products contained synthetic ingredients such as dimethicone and phenoxyethanol (FTC).
• Percentages, “clinically proven” and test results. For health-related claims, the FTC expects “competent and reliable scientific evidence”, with randomized controlled trials as the most reliable form, and it weighs sample size, duration and independent replication (FTC Health Products Compliance Guidance, 2022).
• Testimonials. A claim made through user testimonials needs the same evidence as a direct claim, consumer endorsements alone do not count as scientific evidence, and a “results not typical” note does not fix a misleading testimonial (16 CFR 255.2).
• “Made in USA”. The product must be “all or virtually all” made and sourced in the United States, with final assembly or processing there (16 CFR 323.2). An imported cosmetic filled abroad does not meet this.

Amazon adds its own limits. Listing text and images must not include the FDA logo, must not say “FDA approved” unless the product has FDA approval, must not make disease claims unless FDA has cleared, approved or authorized them, and must not make unverified claims. Amazon’s own example: a skincare product may claim to reduce the appearance of wrinkles, but may not claim to eliminate wrinkles (Amazon policy).

Our standard label review covers the label. Leaflets, websites and other advertising materials can be reviewed on a retainer.

When does Prop 65 require a warning, and how does Amazon handle it?

A Prop 65 warning is needed when a product exposes California consumers to a chemical on the state’s list above its safe harbor level. On Amazon, you provide the warning through the listing’s Compliance tab, and Amazon expects it even if your business has fewer than 10 employees, which the law itself exempts.

What the law says

• California’s Office of Environmental Health Hazard Assessment (OEHHA) keeps the Prop 65 list of chemicals that cause cancer or reproductive harm. No warning is needed if exposure is at or below the safe harbor level (P65Warnings FAQ for businesses).
• Primary responsibility for warnings sits with manufacturers, producers, packagers and importers. Retailers are responsible for placing the warning materials they receive.
• For internet sales, the warning must appear on the product page or through a clear link before the purchase is completed, and it must also be on or with the product.
• Businesses with fewer than 10 employees are exempt under the law.
• Since January 1, 2025, the short-form warning must name at least one listed chemical. Products made and labeled before January 1, 2028 can use either the old or the new short form.

What does Amazon require on top of FDA, FTC and Prop 65?

Amazon’s Cosmetics, skin, and hair care policy adds listing, image, claim and packaging rules for every cosmetic, document requests when Amazon asks, and third-party testing for skin-lightening products (Amazon policy).

Amazon requirement	What it means	Applies to
Listing attributes	Item name, product identifier (UPC, EAN or GTIN), brand, manufacturer, product features, number of items and age range.	All cosmetics
Images	A compliant main image, plus images of the ingredient list and the identity statement.	All cosmetics
Offers	New and sealed in the original packaging, with matrix codes, lot numbers or serial numbers on the packaging.	All cosmetics
Documents on request	Images of the full English label: the MoCRA contact (US address, phone or electronic contact), product name, ingredients, net contents in US units, identity statement, warnings and fragrance allergens.	All cosmetics
Third-party testing (TIC)	An Amazon-authorized testing provider checks every notified ASIN: a test report from an ISO 17025 laboratory issued within 12 months, a cGMP certificate from an ISO 17065-accredited body, and FDA Form 5066 and 5067 records.	Skin-lightening products
Dangerous goods review	Some cosmetics are regulated as dangerous goods for FBA, which needs a safety data sheet or exemption sheet.	Flagged products (Amazon)

Amazon also bans some products outright, including skincare containing mercury, products with plastic microbeads, and products above set acid levels, such as glycolic acid over 70%. For state laws such as California’s cosmetic ingredient bans or New York’s 1,4-dioxane limits, Amazon may restrict who can buy a product in that state, and says sellers do not need to take action.

What does it cost to get a cosmetic ready for Amazon US?

It depends on where you sit in the MoCRA split: a brand whose factory is already FDA-registered pays for its product listing and label review, while a brand whose own factory is not yet registered also pays for facility registration and a US Agent.

Service	Who needs it	GOL fee
Classification: cosmetic or OTC drug, ingredient restrictions and limits	Recommended before R&D and label work	$500 per package of 3 SKUs
MoCRA facility registration	The factory that manufactures or processes the product	$650 per facility per year
US Agent	Foreign factories, for facility registration	$800 per year
MoCRA product listing	The responsible person (brand owner, packer or distributor named on the label)	$150 per product per year
Label review, FDA only	The responsible person	$600 per label
Label review, FDA + FTC + Prop 65	The responsible person	$650 per label

First year, 1 product	Your factory is already FDA-registered	Your own factory still needs registering
MoCRA facility registration	Not needed (the factory already holds it)	$650
US Agent	Not needed	$800
MoCRA product listing	$150	$150
Label review, FDA + FTC + Prop 65	$650	$650
Total	$800	$2,250
Total with classification (up to 3 SKUs)	$1,300	$2,750

GOL service fees. Each additional product adds its listing fee, and a label review if it has its own label. We assess each client and quote their exact cost. Ask your factory for its FDA registration number, because your product listing must include it.

How long does it take?

Plan on about 30 days for the label, because a label review takes 5 to 7 days per round and most labels need 3 rounds. The MoCRA filings and the Amazon listing then follow fixed rules.

Step	Timing	Source
Classification and formula check	Before label design, while the formula can still change	GOL
Label review (FDA, FTC, Prop 65)	5 to 7 days per round, usually 3 rounds, about 30 days in total. Urgent: we completed one 2025 review in 3 business days.	GOL
Facility registration	Within 60 days of starting manufacturing. Renew every 2 years.	21 U.S.C. 364c
Product listing	Within 120 days of first marketing. Update every year.	21 U.S.C. 364c
Amazon listing	Prop 65 warning type at listing creation. Label images and documents when Amazon asks.	Amazon
Serious adverse event reports	Within 15 business days of receiving one.	21 U.S.C. 364a

When does this not apply?

This guide does not fit, or fits only in part, in these situations.

• Your product is an OTC drug or a cosmetic-drug. Sunscreens, anti-dandruff products, acne treatments and hair growth products follow OTC drug rules as well, which this guide does not cover.
• You are a qualifying small business. You are exempt from facility registration and product listing, unless your product is in an excluded category, but labeling, safety substantiation and adverse event reporting still apply.
• Your product is true soap. Amazon’s cosmetics policy does not apply to soap without detergent ingredients.
• Your product is a children’s cosmetic sold as a toy. Amazon’s children’s toys policy applies instead.
• You need your ads reviewed. Our standard label review covers the label only. Leaflets, websites and other advertising materials are reviewed on a retainer.

Frequently asked questions

What should you send GOL for a label review?

Send us the items below and we will review your label against FDA, FTC claims and Prop 65 rules in one pass for $650 per label, and tell you your exact cost for the rest of the stack. Start from our FDA cosmetics registration page.

• Artwork for every panel of the label and outer box.
• The full ingredient list with INCI names, and percentages if you can share them.
• Every claim you plan to use, with the evidence behind it: study reports, sample sizes and who ran the test.