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Cosmetics10 min read

Form FDA 5067 Guide: Cosmetic Product Listing

How to prepare, validate, and maintain product listings under MoCRA with fewer submission errors and cleaner update workflows.

Quick answer

FDA API Gateway
Assurentry Compliance Architecture

Foreign Facility

Raw Data Input

Translation Layer

Validation Active

FDA FURLS

Live Sync

Compliance Vault

Immutable

Form FDA 5067 is the product listing submission used in FDA Cosmetics Direct. It ties product identity and ingredient-related data to responsible product ownership for MoCRA listing obligations.

What is Form FDA 5067?

FSMA Food Safety Workflow

Foreign Supplier

HACCP Plan Required

Assurentry FSVP Engine

Hazard Analysis
Supplier Verification

FDA Systems

Audit Ready Records

Form FDA 5067 is used to list cosmetic products in FDA systems under MoCRA. It supports product-level transparency and compliance workflows.

Who must list products?

510(k) Substantial Equivalence Engine
Input Device
Advanced Surgical Laser
K190234
Laser Scalpel Pro
98% MATCH
K170881
Dermal Light Unit
TECH DIFF

Responsible product owners for covered cosmetic products distributed in the U.S. should maintain complete and current listing records.

Data required for listing

Form 483 Remediation Protocol

FDA Observation

"Procedures for verifying supplier controls were not adequately established."

CAPA Deployed

Assurentry auto-generates a 15-day response plan with acceptable corrective actions.

  • Product identity fields and category alignment
  • Responsible person and contact references
  • Ingredient-related listing attributes
  • Facility linkage and traceability context

Submission sequence

Regulatory Extraction Engine
Automated FDA Document Parsing

Automated Extraction

Our systems parse complex FDA documents into actionable data instantly.

Registration Date
Required Actions
  1. Normalize product master data and naming conventions.
  2. Validate category and ingredient fields for consistency.
  3. Submit listing through Cosmetics Direct.
  4. Track confirmation and schedule update checks.

How to reduce listing rework

  • Use a controlled product taxonomy before filing.
  • Keep ingredient and label source data aligned.
  • Assign clear ownership for listing updates.

Operational update triggers

Trigger listing reviews when formulas change, product names are revised, ownership shifts, or packaging/label data affecting listing fields is updated.

How Assurentry helps

Assurentry automates product listing workflows, validates required fields, and tracks ongoing update obligations so listings stay current as portfolios evolve.

Evidence: FDA MoCRA overview and FDA Cosmetics Direct system.

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Assurentry acts as a technical translation layer. You provide basic business info, and we automatically generate and file the exact electronic submissions required by the FDA.

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