Amazon compliance for beauty and personal care brands
LIVELE manages Amazon compliance for beauty and personal care brands selling on Amazon.com. We track facility registrations and product listings under the Modernization of Cosmetics Regulation Act (MoCRA), ingredient labels, safety records and Amazon's approval documents, ASIN by ASIN, and flag products whose claims make them drugs. The Food and Drug Administration (FDA) has enforced MoCRA registration and listing since July 1, 2024. Compliance Management costs $3,500/month and does not include PPC.
What MoCRA requires of a cosmetics brand
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gave the FDA its first registration and listing system for cosmetics. Sources were last checked on October 7, 2026.
Facilities and products. Cosmetic manufacturers and processors register their facilities with the FDA and renew every two years. A responsible person, usually the brand, lists each product and its ingredients and updates the listing every year (FDA, August 2026). The FDA has enforced registration and listing since July 1, 2024, and offers its Cosmetics Direct portal for both.
Foreign facilities. A factory outside the US registers too and names a US agent. The FDA's guidance says the agent must be physically present in the US; a mailbox or answering service does not qualify (FDA guidance, December 2024).
Safety and adverse events. The responsible person reports serious adverse events to the FDA within 15 business days and keeps records that support each product's safety. Since December 29, 2024, every cosmetic label must give a domestic address, a domestic phone number or electronic contact details, such as a website, for adverse event reports (21 U.S.C. 364e).
Ingredient labels. Ingredients are declared in descending order of predominance; fragrance and flavor may be listed simply as "fragrance" or "flavor" (21 CFR 701.3).
When a beauty product is also a drug
Intended use decides whether a product is a cosmetic, a drug or both, and claims are how the FDA reads intended use. The FDA's examples of products that are both include antidandruff shampoos, fluoride toothpastes, deodorants that are also antiperspirants, and moisturizers or makeup with sun-protection claims. Acne treatments and sunscreens are over-the-counter drug categories (FDA).
A product that is both must meet the rules for cosmetics and for drugs. On Amazon, the listing copy is part of that picture: a bullet that says "treats acne" or "SPF 30" can change what the product is, whatever the label says.
What Amazon asks beauty sellers for
Amazon's guide to selling beauty products lists products that must meet MoCRA requirements for facility registration and adverse event reporting among its restricted examples. To get approved, it asks for invoices from the last 180 days covering at least 10 units, product photos, a GMP certificate, a Certificate of Analysis and MoCRA compliance documentation (Amazon, February 2026).
The same guide lists prohibited items, among them cosmetics with more than 12% hydrogen peroxide and products with plastic microbeads. Amazon staff have also said that testing may be required and that documents may be requested for listings already live (Amazon Seller Forums).
MoCRA rules that are still pending
Fragrance allergens. MoCRA directs the FDA to require fragrance allergens on cosmetic labels. As of October 7, 2026, the FDA has not published the proposed rule, although the law set June 2024 as its deadline.
Talc. The FDA proposed asbestos testing for talc-containing cosmetics in December 2024 and withdrew the proposal on November 28, 2025, saying it will propose a new rule (Federal Register, November 2025).
When either rule moves, it goes into the Amazon policy tracker and into the label review for every affected ASIN.
What LIVELE keeps on file for each beauty ASIN
This is what "documentation, certification and regulatory tracking" means in Compliance Management for a beauty brand. We track and file. Labs test, manufacturers certify and the responsible person files with the FDA.
| Document | Who issues it | What we track |
|---|---|---|
| FDA facility registration (MoCRA) | The manufacturer or processor, with the FDA | Registration per facility, 2-year renewal date, US agent for foreign facilities |
| FDA product listing (MoCRA) | The responsible person, usually your brand | Listing per product, ingredients as filed, annual update date |
| Safety substantiation records | The responsible person | Where the file sits, its date and which formula version it covers |
| Adverse event log | The responsible person | Reports received, serious ones sent to the FDA within 15 business days |
| Label file | Your brand | Ingredient order, domestic contact for adverse events, label version per ASIN |
| GMP certificate and Certificate of Analysis | The manufacturer, or a lab for the COA | Certificate dates and batch numbers, for Amazon approvals and document requests |
| Category approval file | Your suppliers and your brand | Invoices from the last 180 days for 10 or more units, product photos |
| Cosmetic or drug check | Your brand, with regulatory counsel where needed | ASINs with SPF, acne, antidandruff or antiperspirant claims, and listing copy that matches the label |
- We don't formulate, test or certify products, and we don't give legal opinions on drug claims.
Who this is for
Who it’s for
- Beauty and personal care brands with Brand Registry doing roughly $1.5 million or more a year on Amazon.
- Brands with contract manufacturers in several countries, where registrations, US agents and listings multiply.
- Teams that sell SPF, acne or antidandruff products next to plain cosmetics and need the line drawn per ASIN.
Who it’s not for
- Brands that need product testing, formulation or a safety assessor. We work with your lab and assessor, not instead of them.
- Sellers who want a legal opinion on whether a claim makes a product a drug. That is a regulatory attorney's job.
- Resellers without Brand Registry, brands under about $1 million a year on Amazon or anyone looking for PPC management.
Questions beauty brands ask
Is my brand exempt from MoCRA registration as a small business?
Possibly. The exemption applies when average US sales of cosmetic products over the previous 3 years are under $1,000,000, adjusted for inflation. It does not apply to products that regularly touch the mucous membrane of the eye, are injected, are meant for internal use or alter appearance for more than 24 hours. Amazon can still ask for MoCRA documentation when it approves the category.
Is an SPF moisturizer a cosmetic or a drug?
Both. The FDA lists moisturizers and makeup with sun-protection claims among products that are cosmetics and drugs, so they must meet both sets of rules. Sunscreens are an over-the-counter drug category.
What does Amazon need to approve a beauty listing?
Amazon's beauty guide lists invoices from the last 180 days covering at least 10 units, product photos, a GMP certificate, a Certificate of Analysis and MoCRA compliance documentation. Requirements vary by product, so check the request in Seller Central.
Do we need to list fragrance allergens on our labels now?
Not yet. MoCRA requires the FDA to write that rule, and as of October 7, 2026 the proposed rule has not been published. We log it in the policy tracker when it is.
Our factory is outside the US. What does MoCRA need from it?
The factory registers with the FDA and names a US agent who is physically present in the US. A mailbox or an answering service does not qualify. The brand, as responsible person, still lists each product.
Do you file our MoCRA registrations and listings?
Within Compliance Management we track every registration and listing, prepare the data each filing needs and keep the renewal and annual update dates. The filings stay in the name of the facility and the responsible person.
Talk to an Amazon specialist about your beauty catalog
Tell us how many ASINs you sell and what Amazon has asked for. If a listing is already deactivated or Amazon has set a deadline, choose "Urgent" in the form so we read it first.