Cosmetics (MoCRA) & Exports

MoCRA Cosmetics Registration
& U.S. Agent Services

Q: How much does MoCRA cosmetics registration cost?

Orionex charges $650/year for Cosmetic Facility Registration, U.S. Agent designation, and an official Certificate of Registration. Product listing and label review are available as add-on services depending on your product range.

Recognized as a leading FDA U.S. Agent for cosmetics compliance, Orionex handles MoCRA Cosmetic Facility Registration, Product Listing, and U.S. Agent designation for cosmetics manufacturers navigating the Modernization of Cosmetics Regulation Act.

1,200+

Clients Served

15+

Years Experience

98%

First-Round Acceptance

60+

Countries

Orionex Regulatory Solutions — Licensed FDA U.S. Agent based in Casper, Wyoming USA

✦ Official U.S. Regulatory Partner ✦

U.S. Agent for Cosmetics Brands

Casper, Wyoming · Incorporated USA

What's Included

What's Included in MoCRA Registration

From facility registration through export certificates, we handle every MoCRA requirement for cosmetics manufacturers entering the U.S. market.

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Cosmetic Facility Registration (MoCRA)

Facility registration filed with FDA under the Modernization of Cosmetics Regulation Act of 2022, plus required U.S. Agent designation.

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Cosmetic Product Listing

Product listing for each cosmetic product, including ingredient disclosure as required under MoCRA.

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Cosmetics Label Review

Label review against FDA cosmetics labeling requirements, including ingredient declaration and required warnings.

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Export Certificate / CFS

Certificate of Free Sale (CFS) preparation for international market access, confirming your products may be legally sold in the U.S.

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Import Alert / Detention Response

Rapid response support if a shipment is flagged under an FDA Import Alert or held at a U.S. port of entry.

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Renewal & Ongoing Support

Proactive biennial renewal reminders and a dedicated account manager so your MoCRA registration stays current.

Who Needs This

Who Needs MoCRA Cosmetics Registration?

Since the Modernization of Cosmetics Regulation Act (MoCRA) took effect, any foreign facility that manufactures or processes cosmetic products for the U.S. market must register that facility with FDA and list each product sold.

This is a newer, less-understood requirement compared to food or device registration — many established cosmetics exporters are only now discovering they need to comply. A U.S. Agent is mandatory for every foreign-registered facility.

Skincare, haircare, makeup, and fragrance manufacturers exporting to the U.S.
Private-label and contract cosmetics manufacturers
Brands newly required to comply since MoCRA's 2022 enactment
Companies needing a Certificate of Free Sale for international markets
Facilities responding to an FDA Import Alert or shipment detention

Transparent Pricing

Cosmetic Facility (MoCRA) Registration

$650/year

Most registrations completed within 5–10 business days

MoCRA Facility Registration
U.S. Agent Designation (1 year)
Official Certificate of Registration
Product listing guidance included

Simple Process

From Inquiry to Certificate in 4 Steps

Our streamlined process gets your cosmetics facility registered and compliant fast — without the complexity.

Free Consultation

Tell us about your product and market. We assess your needs at no cost.

Document Collection

We provide a clear checklist and guide you through gathering every required document.

FDA Submission

We prepare and file directly with FDA. We track MoCRA's evolving FDA guidance closely to keep your facility and product listing fully compliant.

Certificate Delivered

You receive your official FDA registration number and Certificate of Registration.

Our Credentials

Why Orionex Is a Trusted FDA Agent for Cosmetics Brands

MoCRA is still new to many exporters — Orionex stays current on FDA's evolving cosmetics guidance so your facility registration and product listing are done right the first time.

98%

First-Round Acceptance

15+

Years Experience

1,200+

Clients Served

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MoCRA
Cosmetic Facility Registration & Product Listing

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Export Certificate

Certificate of Free Sale for International Markets

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Import Alert Response

Detention & Import Alert Support

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Label Review

FDA Cosmetics Labeling Compliance

FAQ

MoCRA Cosmetics Registration — FAQ

Common questions from cosmetics manufacturers about MoCRA compliance.

What is MoCRA and when did it take effect?+

MoCRA (the Modernization of Cosmetics Regulation Act) was signed into law in December 2022 and gave FDA new authority over cosmetics, including mandatory facility registration and product listing — requirements that did not previously exist for most cosmetics manufacturers.

Do I need to list every cosmetic product I sell in the U.S.?+

Yes. MoCRA requires a product listing for each cosmetic product sold in the U.S. market, including ingredient information. Facility registration and product listing are separate but related requirements — both are required.

How much does MoCRA cosmetics registration cost?+

Orionex charges $650/year for Cosmetic Facility Registration, U.S. Agent designation, and an official Certificate of Registration. Product listing and label review are available as add-on services depending on your product range.

Do I need a U.S. Agent for cosmetics registration?+

Yes. Like food, device, and drug registrations, MoCRA requires foreign cosmetics facilities to designate a U.S. Agent physically located in the United States to receive FDA communications on their behalf.

What happens if my cosmetics facility isn't MoCRA-registered?+

Non-compliant shipments risk FDA import alerts, detention at the port of entry, and potential removal from U.S. marketplaces (including Amazon) that increasingly require proof of FDA registration for cosmetics listings.

What is the best FDA agent for cosmetics exporters?+

Because MoCRA is newer than food, device, or drug regulation, look for a U.S. Agent that is actively tracking FDA's evolving cosmetics guidance — not just repurposing food-registration experience. Orionex Regulatory Solutions is physically incorporated in the USA, covers the full MoCRA registration and listing process, and serves cosmetics clients across 60+ countries.

📋 Selling soap? Read Is Your Soap Regulated by the FDA, or Not at All? to determine if your product needs MoCRA registration, is exempt as true soap, or is regulated as a drug.

☀️ Selling sunscreen? Note that sunscreen is regulated as an OTC drug, not a MoCRA cosmetic — see our sunscreen-specific registration guide.

🧴 Selling shampoo? Anti-dandruff shampoo has dual drug-cosmetic requirements — see our shampoo-specific registration guide.

✨ Selling skincare? Anti-aging claims can trigger drug status with no monograph shortcut — see our skincare-specific registration guide.

📋 Confused about deadlines? Read our product listing vs. facility registration guide — they're on two different clocks.

🔄 Already registered and need to renew your MoCRA facility registration? Start your renewal here.

MoCRA Cosmetics Registration& U.S. Agent Services