Cosmetic Product Labeling Compliance Checklist

COSMETIC PRODUCT LABELING COMPLIANCE CHECKLIST

MoCRA (Modernization of Cosmetics Regulation Act of 2022) COMPLIANCE

SECTION 1: PRODUCT IDENTIFICATION

1.1 Product Information

1.2 Product Classification

Is this product a cosmetic under FD&C Act?

☐ Yes - Product intended to cleanse, beautify, promote attractiveness, or alter appearance
☐ No - Product may be a drug (makes therapeutic claims)
☐ Dual-status (cosmetic and drug)

Product Type:
☐ Skin care (moisturizers, cleansers, serums)
☐ Hair care (shampoo, conditioner, styling)
☐ Color cosmetics (makeup, nail polish)
☐ Fragrance
☐ Personal hygiene (deodorant, soap)
☐ Baby products
☐ Sun care (non-drug)
☐ Professional salon products
☐ Other: [________________________________]

SECTION 2: MoCRA REQUIREMENTS CHECKLIST

2.1 Facility Registration (Due July 1, 2024)

☐ Facility registered with FDA
☐ Registration renewed (every 2 years in even-numbered years)
☐ Foreign facility has U.S. agent designated

Registration Number: [________________________________]

Registration Expiration: [__/__/____]

2.2 Product Listing (Due July 1, 2024)

☐ Product listed with FDA
☐ Product listing includes:
☐ Responsible person name and contact
☐ Product name
☐ Product category
☐ Complete ingredient list including fragrances, flavors, colors
☐ Listing of facilities where manufactured/processed

Product Listing Number: [________________________________]

2.3 Adverse Event Contact Information (Due December 29, 2024)

Label MUST include domestic contact for adverse event reports:

☐ Domestic address included on label
☐ Domestic phone number included on label
☐ Electronic contact (website) included on label

Contact Information on Label:

[________________________________]

2.4 Small Business Exemption Evaluation

Does the business qualify for small business exemption?

Criteria: Average gross annual sales < $1,000,000 for previous 3 years

☐ Yes - Exempt from GMP, registration, and listing requirements
☐ No - Must comply with all MoCRA requirements

Note: Exemption does NOT apply if products:
☐ Regularly come into contact with mucus membrane of the eye
☐ Are injected
☐ Are intended for internal use
☐ Are intended to alter appearance for >24 hours under customary use

SECTION 3: PRINCIPAL DISPLAY PANEL (PDP) REQUIREMENTS

3.1 Statement of Identity

☐ Common or usual name of the cosmetic present
☐ Appropriately descriptive name included
☐ Fanciful name (if used) accompanied by descriptive name
☐ Statement of identity in bold type
☐ Size reasonably related to most prominent printed matter
☐ Parallel to the base of package

Statement of Identity Used:

[________________________________]

3.2 Net Quantity of Contents

☐ Net quantity statement present
☐ Located in bottom 30% of PDP
☐ Expressed in weight, measure, or numerical count
☐ Dual declaration (metric and U.S. customary)

Net Quantity Declaration:
☐ Weight (oz, g): [________________________________]
☐ Volume (fl oz, mL): [________________________________]
☐ Count: [________________________________]

Minimum Type Size Requirements Met:
| PDP Area | Minimum Height |
|----------|----------------|
| ≤5 sq in | 1/16 inch |
| >5 to ≤25 sq in | 1/8 inch |
| >25 to ≤100 sq in | 3/16 inch |
| >100 to ≤400 sq in | 1/4 inch |
| >400 sq in | 1/2 inch |

☐ Type size requirement verified and compliant

SECTION 4: INFORMATION PANEL REQUIREMENTS

4.1 Name and Address of Manufacturer/Distributor

☐ Name of manufacturer, packer, or distributor present
☐ Street address included (or P.O. Box if listed in directory)
☐ City included
☐ State (or country if foreign) included
☐ ZIP code included

If not manufacturer:
☐ "Manufactured for," "Distributed by," or similar qualifying phrase used

Name and Address as Labeled:

[________________________________]
[________________________________]
[________________________________]

4.2 Adverse Event Contact (MoCRA Requirement)

☐ Domestic address, phone number, OR electronic contact for adverse event reporting included on label

Contact Information:

[________________________________]

SECTION 5: INGREDIENT LABELING (21 CFR 701.3)

5.1 Ingredient Declaration Format

☐ Heading "Ingredients" or equivalent present
☐ Ingredients listed in descending order of predominance
☐ Ingredients at 1% or less may be listed in any order after those >1%
☐ Color additives may be listed in any order after other ingredients
☐ INCI (International Nomenclature Cosmetic Ingredient) names used

5.2 Ingredient List Verification

5.3 Color Additives

☐ All color additives listed
☐ Color additives approved for intended use (21 CFR Parts 73, 74, 82)
☐ Certification required colors properly certified (if applicable)

5.4 Fragrance and Flavor

☐ Fragrance ingredients may be declared as "fragrance" or "parfum"
☐ Flavor ingredients may be declared as "flavor"

Note: MoCRA requires fragrance allergen labeling (FDA rulemaking expected May 2026)

5.5 Trade Secret Ingredients

☐ N/A - No trade secret ingredients
☐ Trade secret petition filed with FDA
☐ FDA granted trade secret status - ingredient declared as approved alternate name

SECTION 6: WARNING STATEMENTS (21 CFR Part 740)

6.1 General Warning Requirements

☐ All required warnings present
☐ Warnings prominently and conspicuously displayed
☐ Warnings in terms likely to be understood by ordinary consumers

6.2 Specific Product Warnings

For Products Not Adequately Tested for Safety:

☐ "Warning: The safety of this product has not been determined"

For Aerosol Products:

☐ "Warning: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children."
☐ Intentional misuse warning (if applicable)

For Feminine Deodorant Sprays:

☐ "Caution: For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops."

For Coal Tar Hair Dyes:

☐ Patch test caution statement
☐ "Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness."

For Products Containing Foaming Detergent:

☐ Eye contact warning (if applicable)

For Tanning Products Without Sunscreen:

☐ Sun exposure warning (if applicable)

6.3 Custom Warning Statements

SECTION 7: CLAIMS REVIEW

7.1 Prohibited Claims

☐ No drug claims (diagnose, treat, cure, prevent disease)
☐ No false or misleading statements
☐ No claims not supported by evidence

7.2 Acceptable Cosmetic Claims

☐ Cleansing
☐ Beautifying
☐ Promoting attractiveness
☐ Altering appearance (temporary)
☐ Moisturizing
☐ Other permitted claims

7.3 Claims Review

SECTION 8: SPECIAL LABELING REQUIREMENTS

8.1 Professional Use Products

☐ N/A - Consumer product
☐ Product labeled for professional use only
☐ Professional labeling requirements met

8.2 Multi-Use Products

☐ N/A - Single use product
☐ Adequate directions for all uses

8.3 Salon/Professional Products (MoCRA)

Professional products must still include:
☐ Fragrance allergen labeling (when required)
☐ Adverse event contact information

SECTION 9: PACKAGING REQUIREMENTS

9.1 Package Integrity

☐ Package protects product integrity
☐ Tamper-evident packaging (if applicable)
☐ Child-resistant packaging (if required)

9.2 Small Package Exemptions

For packages with PDP ≤12 sq cm (inner container):
☐ May omit ingredient declaration from inner container if on outer container
☐ Type size requirements modified appropriately

SECTION 10: COMPLIANCE VERIFICATION

10.1 Final Label Review Checklist

Principal Display Panel:
☐ Statement of identity
☐ Net quantity of contents
☐ Proper type sizes

Information Panel:
☐ Name and place of business
☐ Adverse event contact information (MoCRA)
☐ Ingredient declaration
☐ Required warnings
☐ Directions for safe use

Regulatory Requirements:
☐ Facility registered with FDA (MoCRA)
☐ Product listed with FDA (MoCRA)
☐ No prohibited ingredients
☐ Color additives approved for use
☐ No misleading claims

10.2 Label Approval

Label Approved: ☐ Yes ☐ No - Revisions Required

Approved By: [________________________________]

Title: [________________________________]

Date: [__/__/____]

Signature: ________________________________________

10.3 Revisions Required

SECTION 11: RECORD RETENTION

11.1 Documentation to Retain

☐ Final approved label artwork
☐ Ingredient specifications and INCI verification
☐ Color additive certifications
☐ Safety substantiation data
☐ Claim substantiation data
☐ Label review and approval records
☐ MoCRA registration and listing confirmations

Retention Period: Minimum [____] years after last distribution

IMPORTANT REGULATORY NOTES

MoCRA Key Deadlines

• July 1, 2024: Facility registration and product listing required
• December 29, 2024: Adverse event contact information on labels required
• December 29, 2025: GMP requirements effective (final rule pending)
• May 2026 (expected): Fragrance allergen labeling proposed rule

Small Business Exemptions

Businesses with <$1M average gross annual sales exempt from:

• GMP requirements
• Facility registration
• Product listing

BUT exemption does NOT apply to:

• Eye area products
• Injectable products
• Internal use products
• Products altering appearance >24 hours

Prohibited/Restricted Ingredients

• Mercury compounds (except as preservatives in eye area products ≤65 ppm)
• Chlorofluorocarbon propellants
• Chloroform
• Vinyl chloride
• Halogenated salicylanilides
• Zirconium in aerosol cosmetics
• PFAS (varies by state)

SOURCES AND REFERENCES

• MoCRA: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
• 21 CFR Part 701 - Cosmetic Labeling
• 21 CFR Part 740 - Cosmetic Product Warning Statements
• FDA Cosmetic Labeling Guide
• INCI Dictionary (PCPC)

This template is provided for informational purposes only. Cosmetic labeling requirements vary by product type and target market. Consult with an FDA regulatory attorney for specific compliance guidance.