FDA Cosmetic Product Listing & US Labels
Axentra Global Pharma Compliance LLC offers vital support for businesses navigating MoCRA regulations. From FDA registration to U.S. Agent responsibilities for FDA, our services ensure seamless compliance. By partnering with us, brands can focus on growth while we handle regulatory complexities. With Axentra, you gain a trusted ally to streamline operations and meet all compliance requirements effortlessly.
The Modernization of Cosmetics Regulation Act (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA) has fundamentally changed how cosmetic products are regulated in the United States. For U.S. brands and global manufacturers alike, MoCRA covers FDA facility registration and product listing filings, adverse event reporting, and FDA oversight.
Axentra Global Pharma Compliance LLC supports cosmetic companies with structured, audit-ready MoCRA compliance, allowing sales and marketing teams to launch, expand, and rebrand products without regulatory surprises.
Who This Service Is Designed For
MoCRA compliance impacts more than regulatory teams — it directly affects commercialization timelines, product launches, and brand continuity.
Sales & Marketing Directors
Brand Owners & Founders
Regulatory & QA Managers
Leading U.S. cosmetic and OTC launches while managing new package sizes, refreshed artwork, label changes, and claim updates — often under tight deadlines.
Frequently searching for fast, reliable support for label compliance review, packaging updates, MoCRA requirements, or FDA regulatory advice to avoid launch delays, reprints, or retail pushback
Scaling cosmetic brands in the U.S. market and needing FDA cosmetic compliance support without hiring a full-time regulatory team.
Often looking for MoCRA consultants, U.S. Agent services, cosmetic labeling help, or regulatory support for new SKUs and package sizes to stay compliant while focusing on growth.
Managing FDA and MoCRA compliance internally while supporting commercial teams with product listing updates, artwork changes, adverse event reporting, and inspection readiness.
Typically searching for on-demand regulatory support, cosmetic compliance expertise, FDA guidance, or external regulatory partners to supplement internal resources during peak workload periods.
What MoCRA Covers — and Where Brands Are Exposed
MoCRA is not a one-time filing. It is an ongoing FDA process for facility registration, product listing, and labels.
Axentra helps you operationalize MoCRA compliance so regulatory requirements do not block commercial execution.
01
Cosmetic facility registration with FDA
FDA facility registration filings for owners and contract manufacturers.
02
Cosmetic product listing and updates
Detailed ingredient and labeling submission for every SKU.
03
Adverse event reporting and record retention
Strict 15-day reporting window for serious safety events.
04
Maintenance of safety substantiation
Documented proof of safety for every formula on the market.
05
Labeling and claims compliance
Updated contact info and professional-use disclosures to avoid "Misbranding."
MoCRA Facility Registration
We prepare and submit cosmetic facility registration and manage updates/renewals.
Labeling & Claims Compliance Review
Fast review of cosmetic + OTC-style claims, label panels, and marketing language to reduce enforcement and retailer risk.
MoCRA Product Listing
Structured product listing support, updates for formula/label/size changes, and portfolio maintenance.
U.S. Agent Representation for Cosmetics
A reliable U.S. point-of-contact for compliance communications—aligned with your existing U.S. Agent positioning
Adverse Event Management
Setup of intake, documentation, follow-up workflow, and regulatory reporting to meet MoCRA expectations.
Serious Adverse Event Reporting & Post-Market Safety Requirements
Under the Modernization of Cosmetics Regulation Act (MoCRA), Responsible Persons must report Serious Adverse Events (SAEs) to the FDA within 15 business days and maintain supporting documentation for up to six years.
Compliance requires more than policy statements. Companies must implement structured intake procedures, seriousness assessment criteria, regulatory submission workflows, and documented record retention systems.
For companies marketing in both the United States and the European Union, SAE (US) and SUE (EU) reporting obligations must be aligned within a defensible compliance framework.
Learn more about MoCRA adverse event reporting requirements and global cosmetovigilance expectations in our detailed guide:
MoCRA Compliance — Frequently Asked Questions
How quickly must serious adverse events be reported under MoCRA?
A responsible person must report a serious adverse event to FDA within 15 business days of receiving the report, using MedWatch Form 3500A. If new medical or other information about the event arrives within one year of that report, it must also be submitted within 15 business days.
Who needs MoCRA compliance support?
Cosmetic brand owners and founders, sales and marketing directors managing U.S. launches, and regulatory or QA managers responsible for FDA and MoCRA compliance for cosmetic and OTC products in the U.S. market.
Does Axentra act as a U.S. Agent for cosmetics under MoCRA?
Yes. Axentra serves as the U.S. agent for foreign cosmetic facilities — receiving FDA communications, handling facility registration and product listing in Cosmetics Direct, and acting as your U.S. point of contact for adverse event and import matters.
Is MoCRA registration or listing FDA approval of the cosmetic?
No. Cosmetic facility registration and product listing is not a cosmetic approval program. FDA does not issue certificates for those submissions. FDA does not have authority to approve cosmetics before they go on the market (color additives used in cosmetics are a separate approval).
How does FDA treat cosmetic facility registration versus product listing?
FDA treats them as two different filings. Facility registration (Form FDA 5066) is for the manufacturing/processing facility. Product listing (Form FDA 5067) is submitted by the responsible person for each marketed cosmetic and may be submitted with a registration or separately.
Related: U.S. Agent services dietary supplement FDA compliance. Dietary supplements are not filed under MoCRA; they use food facility registration and a U.S. Agent. See also cosmetovigilance services and INCI and cosmetic US labels.
Flat $249 per facility per year for U.S. Agent appointment, facility registration, and FDA communications. Listing and labels scoped separately. Not an FDA fee.
What is MoCRA facility registration vs product listing?
Facility registration (Form FDA 5066) and product listing (Form FDA 5067) are separate submissions in FDA Cosmetics Direct. Registration and listing are compliance filings—not FDA product approval or a marketing certificate.
How often should a MoCRA cosmetic facility registration be renewed?
Unlike food facility renewal’s fixed OctDec even-year window, MoCRA renewal dates are based on the initial registration date (FDA example: registered Feb 20, 2024 → renew by Feb 20, 2026). Cosmetics Direct supports biennial renewal and abbreviated renewal when information is unchanged.