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MoCRA • FPLA • 21 CFR 701

Cosmetic Label Review.

The rules have changed. MoCRA introduces new requirements for contact information, professional use labeling, and fragrance allergen disclosure. We ensure you're compliant.

FDA Accepted
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Identity
Face Serum
Net Qty
30mL / 1 fl oz
INCI Deck
Validated
MOCRA ENFORCEMENT ALERT: NEW FRAGRANCE ALLERGEN DISCLOSURE REQUIREMENTS
COMPLIANCE DEADLINE: FACILITY REGISTRATION AND PRODUCT LISTING NOW MANDATORY
WARNING: PROFESSIONAL USE PRODUCTS MUST COMPLY WITH NEW LABELING RULES
SAFETY SUBSTANTIATION: RECORDS MUST BE AVAILABLE FOR FDA INSPECTION
MOCRA ENFORCEMENT ALERT: NEW FRAGRANCE ALLERGEN DISCLOSURE REQUIREMENTS
COMPLIANCE DEADLINE: FACILITY REGISTRATION AND PRODUCT LISTING NOW MANDATORY
WARNING: PROFESSIONAL USE PRODUCTS MUST COMPLY WITH NEW LABELING RULES
SAFETY SUBSTANTIATION: RECORDS MUST BE AVAILABLE FOR FDA INSPECTION
MOCRA ENFORCEMENT ALERT: NEW FRAGRANCE ALLERGEN DISCLOSURE REQUIREMENTS
COMPLIANCE DEADLINE: FACILITY REGISTRATION AND PRODUCT LISTING NOW MANDATORY
WARNING: PROFESSIONAL USE PRODUCTS MUST COMPLY WITH NEW LABELING RULES
SAFETY SUBSTANTIATION: RECORDS MUST BE AVAILABLE FOR FDA INSPECTION
Display Panel

Principal Display.

The PDP has strict zones. Your Statement of Identity must be prominent. Net Quantity must be in the bottom 30%. We check font sizes, contrast, and placement against FPLA standards.

Identity Statement Verification
Net Quantity Formatting
Audit My PDP
VELVET
Face Cream
50 mL (1.7 fl oz)
Bottom 30% PDP
PDP
Parsing INCI database...
Water (Aqua)
VALID
Vitamin E
INVALID NAME
Use: Tocopherol
Glycerin
VALID
Shea Butter
FORMAT
Use: Butyrospermum Parkii (Shea) Butter
Nomenclature

INCI Parsing.

“Vitamin E” or “Tocopherol”? “Water” or “Aqua”? FDA requires specific common names. We scan your deck for unauthorized synonyms and formatting errors.

Scan Ingredient Deck
MoCRA Update

Contact Information.

MoCRA now requires a domestic address, phone number, or electronic contact (website) on the label specifically for adverse event reporting.

Check Contact Req
OUTDATED
Old Label
Distributed by:
Glamour Inc.
Paris, France
Missing Domestic Contact
COMPLIANT
MoCRA Format
Distributed by:
Glamour Inc.
Paris, France
www.glamour.com/contact
OR
123 Fashion Ave, NY 10012
Adverse Event Contact

Safety Substantiation

If you cannot prove safety, you must display this warning on the PDP:

“Warning: The safety of this product has not been determined.”
Testing Records
Toxicological Assessment
21 CFR 740.10

Safety Substantiation.

If you haven't adequately substantiated the safety of your product (through testing or toxicological assessment), you MUST display a specific warning on the PDP.

Assess Safety Data
Salon Products

Professional Use.

Selling to salons? MoCRA now requires professional-use products to include the same ingredient labeling as retail products. The “For Professional Use Only” exemption is narrowing.

Update Pro Labels
Retail Pack
SALON ONLY
Professional Use
For Professional Use Only.
Not for Retail Sale.
Requirements:
  • Specific Cautionary Statements
  • Directions for Safe Use
  • Ingredient Declaration (MoCRA Update)
Structure/Function
“Reduces the appearance of wrinkles.“
Valid Cosmetic Claim
Drug Claim
Eliminates wrinkles.“
Warning Letter Risk
21 CFR 700.35
Marketing

Claims Analysis.

“Anti-aging” is cosmetic. “Acne treatment” is a drug. We analyze your claims to ensure you haven't accidentally created an unapproved new drug.

Analyze Claims
Metrology

Net Quantity.

Solids by weight (g/oz). Liquids by volume (mL/fl oz). Placement must be in the bottom 30% of the PDP parallel to the base. We verify your calculations.

Verify Calculations
50g
||
Solid / Semisolid
Weight (oz/g)
100mL
(3.4 fl oz)
Liquid
Volume (fl oz/mL)
Dual Declaration (Metric + US)
Prominence Requirement
Warning Statement
“Caution: Avoid contact with eyes. If contact occurs, rinse thoroughly with water.”
Must be bold type on contrasting background
Principal Display Panel
Preferred
Information Panel
Allowed with reference
Hazard Labels

Warning Placement.

Specific cosmetics (foaming baths, feminine sprays, tanning products) require mandatory warning statements. They must be prominent and conspicuous.

Check Warnings
Responsibility

Distributor Info.

Name and place of business must be listed. If the listed address is not in a current directory, the street address must be included.

Validate Info
Manufacturer / Distributor
Corporate Name
Luxe Beauty Inc.
Place of Business
New York, NY 10012
Zip Code Sufficient (if in directory)
Eye Area
Strict
Iron Oxides
Coal Tar Dyes
Lip Area
Ingestion Risk
D&C Red No. 7
Certain Neon Pigments
Must declare specific color additives by name.
Batch Certification

Color Additives.

Color additives are strictly regulated. Eye area products have different allowed lists than lip products. We verify every pigment against 21 CFR 73/74.

Screen Color Additives
Traceability

Batch Coding.

Every cosmetic product must carry a batch or control number for traceability. This is critical for MoCRA adverse event reporting and recall management.

Setup Traceability
PKG
LOT: A24-0992
Traceability

Mandatory for adverse event reporting and recall management.

Shelf Life

Expiration date recommended but not mandatory unless drug claim made.

Platform vs. Designers.

Don't rely on a graphic designer for regulatory compliance.

Comparison
Design Agency
Aesthetics Only
Safe & Legal
Assurentry
Platform
INCI Validation
Cross-check vs Dictionary.
Manual
Automated
MoCRA Compliance
New facility & listing rules.
Awareness
Full Audit
Claims Review
Avoid drug claims.
Copywriter
Regulatory
Turnaround
Speed to launch.
2-3 Weeks
3 Days
Allergen Screen
Fragrance allergens.
Extra Fee
Included

Launch with confidence.

Ensure your packaging meets MoCRA, FPLA, and state laws before you print.

Frequently Asked Questions

Common questions about this regulatory requirement.

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