E-commerce sellers listing cosmetics, skincare, hair care, or personal care products
MoCRA Cosmetics Compliance for E-Commerce Sellers (2026)
The Modernization of Cosmetics Regulation Act (MoCRA) is the biggest change to U.S. cosmetics law in 86 years. If you sell skincare, makeup, hair care, soap, or any product marketed for cleansing or beautifying, these rules now apply to you — including small sellers and private label brands. Here's what you actually need to do.
Quick Answer
Under MoCRA, cosmetics sellers must register their manufacturing facility with the FDA, list each product in the FDA system, maintain adverse event records, ensure proper labeling (including fragrance allergens by 2027), and follow GMP guidelines. Small businesses with under $1M in annual sales get some exemptions but still must register and list products.
Why You're Probably Here
Amazon asked for FDA cosmetics facility registration or product listing number
Amazon is increasingly enforcing MoCRA requirements. Sellers without FDA registration numbers may face listing suppression or removal for cosmetics categories.
You launched a private label skincare or beauty brand and aren't sure what's required
Private label sellers are the "responsible person" under MoCRA — not the contract manufacturer. You are legally responsible for registration, listing, and adverse event reporting.
You received a customer complaint about a reaction to your product
Under MoCRA, serious adverse events must be reported to the FDA within 15 business days. Failure to report can result in enforcement action.
What Matters Most
You are the "responsible person" — not your manufacturer
MoCRA makes the brand owner the responsible person. Even if a contract manufacturer makes your product, you are legally responsible for registration, listing, labeling, and adverse event reporting.
Small business exemptions exist but are limited
Businesses with under $1M in average annual cosmetics sales are exempt from some GMP and recordkeeping requirements, but must still register facilities, list products, and report serious adverse events.
Facility registration and product listing are free
Both are done through the FDA's Cosmetics Direct portal at no cost. Don't pay a third-party company hundreds of dollars to "file your FDA registration" — it's a simple online form.
Requirements
FDA Facility Registration
RequiredMoCRA Section 607
Every facility that manufactures or processes cosmetics for U.S. distribution must register with the FDA. This includes contract manufacturers and foreign facilities.
Why it applies: If you have products made for you (private label) or manufacture yourself, the production facility must be FDA-registered.
What this means for you: Your manufacturer needs to register with the FDA. If they're overseas, they still need to register. If they won't, that's a red flag. Registration is free and done online through the FDA's Cosmetics Direct portal.
Cosmetic Product Listing
RequiredMoCRA Section 608
Each cosmetic product must be listed with the FDA, including ingredient lists and product categories.
Why it applies: Every product you sell — even variations like different shades or scents — needs to be listed in the FDA system.
What this means for you: You list each product through the FDA's Cosmetics Direct system. It's free but tedious — you need full ingredient lists and product categories for each SKU.
Adverse Event Reporting
RequiredMoCRA Section 605
Serious adverse events (hospitalization, significant disability, birth defects) must be reported to the FDA within 15 business days of receiving the report.
Why it applies: As the "responsible person," the brand owner (you) must maintain records of all adverse event reports and report serious ones to the FDA.
What this means for you: If a customer emails you saying your face cream sent them to the ER, you have 15 business days to report it to the FDA. Keep records of all customer complaints about reactions.
Cosmetics Labeling Requirements
Required21 CFR 701, FD&C Act 602
Cosmetics must list ingredients in descending order (INCI names), include warnings where applicable, and display the responsible person's name and address.
Why it applies: All cosmetics sold in the U.S. need proper labeling. MoCRA added new fragrance allergen disclosure requirements starting in 2027.
What this means for you: Your label needs an ingredient list (INCI names, not marketing names), your business name and address, net quantity, and any required warnings. Fragrance allergen listings become mandatory in 2027.
Good Manufacturing Practice (GMP)
ImportantMoCRA Section 606
Cosmetics must be manufactured in accordance with good manufacturing practices. FDA is expected to finalize specific GMP rules for cosmetics.
Why it applies: GMP ensures products are consistently produced and controlled. FDA has proposed rules modeled on existing industry standards (ISO 22716).
What this means for you: Your manufacturer should follow ISO 22716 (cosmetics GMP). Ask for their GMP certification or audit results. If they can't provide any quality documentation, find a new manufacturer.
California Proposition 65
ImportantCal. Health & Safety Code 25249.6
Cosmetics containing Prop 65 listed chemicals (lead, titanium dioxide, certain fragrance chemicals) above safe harbor levels require California warnings.
Why it applies: Many cosmetics contain trace amounts of Prop 65-listed substances. Bounty hunter lawsuits targeting cosmetics are increasing.
What this means for you: If selling cosmetics to California, add Prop 65 warnings for products containing lead, titanium dioxide, or certain fragrance ingredients. Testing costs $200-$400 and protects against lawsuits.
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What Sellers Get Wrong
Assuming "cosmeceuticals" are exempt because they're marketed as skincare
Why sellers do this: Sellers think products with active ingredients like retinol or vitamin C are drugs, not cosmetics.
The reality: If your product is intended to beautify, cleanse, or alter appearance, it's a cosmetic under MoCRA — regardless of active ingredients. Some products may be both a drug and a cosmetic, which means double regulation.
Thinking your contract manufacturer handles all compliance
Why sellers do this: Sellers assume the manufacturer is responsible for FDA compliance.
The reality: The brand owner is the responsible person under MoCRA. Your manufacturer must register their facility, but you are responsible for product listing, labeling, and adverse event reporting.
Using marketing ingredient names instead of INCI names on labels
Why sellers do this: Sellers want labels to read well for consumers.
The reality: FDA requires INCI (International Nomenclature of Cosmetic Ingredients) names on ingredient lists. "Vitamin E" must be listed as "Tocopheryl Acetate" (or the specific form used).
Not keeping adverse event records because you've never had a complaint
Why sellers do this: Small sellers think adverse event reporting only applies to big brands.
The reality: You must maintain a system to receive, track, and report adverse events from day one. Even negative Amazon reviews describing skin reactions could qualify.
What Most Guides Won't Tell You
Check if your product is actually a drug, not just a cosmetic
Products claiming to treat acne, reduce wrinkles, provide sun protection, or promote hair growth are drugs under FDA law — even if marketed as skincare. Drugs have much stricter requirements (NDAs, OTC monographs).
Fragrance allergen disclosure is coming in 2027 — prepare now
MoCRA requires disclosure of specific fragrance allergens on labels by late 2027. If your products contain fragrance, start getting full allergen breakdowns from your fragrance supplier now to avoid a last-minute label redesign.
Soap is exempt from MoCRA — but most "soaps" aren't actually soap
True soap (alkali salts of fatty acids, marketed only for cleansing) is exempt. But if your "soap" contains synthetic detergents, or if you claim it moisturizes, deodorizes, or has any cosmetic benefit, it's a cosmetic under MoCRA.
PFAS bans are spreading fast
Multiple states have banned intentionally added PFAS in cosmetics (California, Maryland, others following). If your manufacturer uses PFAS-containing ingredients, you need to reformulate or face state enforcement.
What To Do Next
Confirm your manufacturer's FDA facility registration
Ask your manufacturer for their FDA facility registration number. If they don't have one, they need to register through FDA's Cosmetics Direct portal before you can sell.
List each product in the FDA Cosmetics Direct system
Create an account on the FDA's Cosmetics Direct portal and list every product you sell, including full ingredient lists in INCI format.
Audit your labels for compliance
Verify ingredient lists use INCI names in descending order, required warnings are present, your business name and address are displayed, and net quantity is correct.
Set up an adverse event tracking system
Create a process to monitor customer complaints (including Amazon reviews) for adverse events and report serious ones to FDA within 15 business days.
Run a Prodovo Labs scan for your specific product
Cosmetics requirements vary by product type (color cosmetics vs. skincare), target market (children's cosmetics have extra rules), and sales region. A scan identifies everything that applies.
Frequently Asked Questions
Does MoCRA apply to small sellers and private label brands?
Is my handmade soap exempt from MoCRA?
How much does MoCRA compliance cost?
What happens if I don't comply with MoCRA?
Do I need to test my cosmetics?
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