Cosmetic Product Labeling Compliance Checklist

COSMETIC PRODUCT LABELING COMPLIANCE CHECKLIST

Use this checklist with the current product formula, package, label artwork, claims, distribution plan, and FDA submissions. It does not replace a product-specific review of drug, device, soap, state, or foreign-law requirements.

SECTION 1: PRODUCT IDENTIFICATION

1.1 Product Information

1.2 Product Classification

Classification gate under 21 U.S.C. § 321 and 21 CFR § 701.20:

☐ Cosmetic: intended to cleanse, beautify, promote attractiveness, or alter appearance
☐ Drug/cosmetic: intended use also includes diagnosing, curing, mitigating, treating, or preventing disease, or affecting body structure or function
☐ Device or another regulated product: separate requirements identified
☐ Soap exclusion confirmed: composition, cleansing action, labeling, sale, and representation all meet 21 CFR § 701.20(a)

Product Type:
☐ Skin care (moisturizers, cleansers, serums)
☐ Hair care (shampoo, conditioner, styling)
☐ Color cosmetics (makeup, nail polish)
☐ Fragrance
☐ Personal hygiene
☐ Baby products
☐ Suntanning preparation without sunscreen
☐ Sunscreen or product making sun-protection claims (drug review required)
☐ Professional salon products
☐ Other: [________________________________]

SECTION 2: MoCRA OPERATING REQUIREMENTS

2.1 Facility Registration

☐ Registration duty and any facility exemption evaluated under 21 U.S.C. §§ 364c and 364h
☐ Existing covered facility is registered
☐ New covered facility is registered within 60 days after first manufacturing or processing cosmetics for U.S. distribution
☐ Registration changes are reported within 60 days
☐ Registration is renewed every two years from the initial registration date
☐ Foreign facility registration identifies its U.S. agent and required contact information

Facility Registration Number: [________________________________]

Initial Registration Date: [__/__/____]

Next Renewal Date: [__/__/____]

2.2 Cosmetic Product Listing

☐ Listing duty and any product exemption evaluated under 21 U.S.C. §§ 364c and 364h
☐ Product first marketed after December 29, 2022, was listed within 120 days after marketing in interstate commerce
☐ Product listing is reviewed annually and any updates are submitted annually
☐ Listing identifies each manufacturing or processing facility registration number
☐ Listing includes the responsible person's name and contact number, labeled product name, category, ingredients, and prior listing number, if any

Product Listing Number: [________________________________]

Last Annual Update: [__/__/____]

2.3 Adverse-Event Contact and Reporting

☐ Label includes at least one channel through which the responsible person can receive reports: domestic address, domestic phone number, or electronic contact information
☐ Intake process captures the report date, product, event, reporter, and label used
☐ Serious adverse event is submitted to FDA with a copy of the retail-package label no later than 15 business days after receipt
☐ New and material medical information received within one year is submitted no later than 15 business days after receipt

Label Contact Channel: [________________________________]

Responsible Intake Team: [________________________________]

2.4 Small-Business Exemption Evaluation

☐ Average U.S. gross annual sales of cosmetic products for the prior three years calculated
☐ Current inflation-adjusted threshold for the statutory $1,000,000 amount documented
☐ Business is below the threshold
☐ Business does not manufacture or process any excluded product listed below

The exemption removes only the requirements of 21 U.S.C. §§ 364b and 364c. It does not remove labeling, safety-substantiation, or adverse-event duties.

Exemption is unavailable for:

☐ Products that regularly contact the eye's mucous membrane under customary or usual use
☐ Injected products
☐ Products intended for internal use
☐ Products intended to alter appearance for more than 24 hours where consumer removal is not part of customary or usual use

Conclusion: ☐ Exempt from §§ 364b and 364c ☐ Not exempt ☐ Counsel review required

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 used only where the product's nature is obvious and consumers understand the name to identify the cosmetic
☐ 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 the bottom 30% of the PDP, unless a regulatory exception applies
☐ Expressed in the form required for the product's consistency or established consumer usage
☐ U.S. customary declaration complies with 21 CFR § 701.13
☐ SI metric declaration included unless a 15 U.S.C. § 1453 exception applies
☐ Inner-container, display-card, kit, aerosol, or very-small-package exception documented, if used

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, unless it appears in a current city or telephone 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

☐ 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
☐ Each ingredient name follows the hierarchy in 21 CFR § 701.3(c), rather than an assumed blanket INCI rule
☐ Ingredient declaration is at least 1/16 inch high unless a specific small-package alternative applies

5.2 Ingredient List Verification

5.3 Color Additives

☐ All color additives listed
☐ Each color additive is permitted for the intended cosmetic use and complies with applicable restrictions in 21 CFR Parts 73, 74, 81, and 82
☐ Certification required colors properly certified (if applicable)

5.4 Fragrance and Flavor

☐ Qualifying fragrance ingredients may be declared as "fragrance"
☐ Flavor ingredients may be declared as "flavor"

☐ Current FDA rulemaking status checked before release; 21 U.S.C. § 364e(b) requires FDA to define label allergens by regulation, and no final fragrance-allergen rule was located as of the verification date

5.5 Trade Secret Ingredients

☐ N/A - No trade secret ingredients
☐ FDA has accepted the ingredient as exempt from public disclosure
☐ Label uses only the substitute declaration authorized by 21 CFR § 701.3(a)

SECTION 6: WARNING STATEMENTS (21 CFR Part 740)

6.1 General Warning Requirements

☐ Product-specific hazards and each applicable Part 740 warning identified
☐ Warning is prominent, conspicuous, bold, contrasting, and at least 1/16 inch high unless FDA has established an alternative
☐ Directions and warnings needed to prevent a health hazard are included

6.2 Specific Product Warnings

Safety substantiation:

☐ Records support adequate substantiation of safety under 21 U.S.C. § 364d
☐ Product is not released on the assumption that the § 740.10 statement cures failure to satisfy MoCRA safety-substantiation duties
☐ If § 740.10 applies, PDP states: "Warning—The safety of this product has not been determined."

For self-pressurized containers:

☐ "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."
☐ Permitted product-specific wording adjustment under 21 CFR § 740.11(a)(2)-(4) documented, if used
☐ If required by § 740.11(b): "Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal."

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."
☐ Eight-inch sentence omitted only if the product meets the § 740.12(b) propellant condition

For Coal Tar Hair Dyes:

☐ "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."
☐ Labeling includes adequate directions for the preliminary test

For foaming detergent bath products not labeled exclusively for adults:

☐ Adequate directions for safe use are included
☐ "Caution—Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children."

For suntanning preparations without a sunscreen ingredient:

☐ "Warning—This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn."

6.3 Custom Warning Statements

SECTION 7: CLAIMS REVIEW

7.1 Classification and Misbranding Review

☐ No disease or body structure/function claim unless the product also complies with applicable drug or device law
☐ No false or misleading statements
☐ Material facts needed to keep each claim from being misleading are disclosed
☐ Evidence supporting express and implied claims is retained

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 is intended only for use by a state-licensed cosmetology, nail-care, barbering, or esthetics professional
☐ Label clearly and prominently states that the product is to be administered or used only by licensed professionals
☐ All otherwise applicable cosmetic-labeling requirements are 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 a final FDA regulation makes it applicable
☐ Adverse event contact information

SECTION 9: PACKAGING REQUIREMENTS

9.1 Package Integrity

☐ Package protects product integrity
☐ Container is not poisonous, deleterious, or misleading
☐ Any drug, special-packaging, transport, or state packaging requirement separately identified

9.2 Small Package Exemptions

☐ Total package surface area available for labeling measured in square inches
☐ For a package under 12 square inches, the exact conditions of 21 CFR § 701.3(i), (o), or (p) are met before using accompanying labeling, a composite list, or 1/32-inch type
☐ Any firmly affixed tag, tape, or card complies with § 701.3(b)
☐ Ingredient declaration is omitted from an inside container only when § 701.3(q) applies: the retail package is fully labeled and the inside container is not intended or customarily separated for retail sale

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:

☐ Registration and listing duties or exemptions documented
☐ Current FDA prohibited/restricted ingredient page and applicable regulations checked ingredient by ingredient
☐ Color additives approved for use
☐ Safety substantiation records complete
☐ Serious-adverse-event workflow tested
☐ Current GMP and fragrance-allergen rulemaking status checked
☐ 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 § 701.3 naming verification
☐ Color additive certifications
☐ Safety substantiation data
☐ Claim substantiation data
☐ Label review and approval records
☐ MoCRA registration and listing confirmations

Adverse-event records: ☐ 6 years ☐ 3 years for a qualifying § 364h small business that does not manufacture or process an excluded product

Other records retention period and basis: [________________________________]

CURRENT-RULE STATUS CHECK

As of the verification date, FDA's current MoCRA page states that FDA must establish cosmetic GMP and fragrance-allergen regulations. No final fragrance-allergen rule or cosmetic GMP rule was located in the current Federal Register search. Do not substitute MoCRA's rulemaking deadlines for an operative compliance date. Recheck FDA and the Federal Register immediately before label approval.

State and foreign requirements may impose additional ingredient, allergen, environmental, packaging, or reporting duties. Record each market-specific review separately.

SOURCES AND REFERENCES

• FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• FDA — Registration and Listing of Cosmetic Product Facilities and Products
• FDA — Prohibited & Restricted Ingredients in Cosmetics
• 21 U.S.C. § 321
• 21 U.S.C. § 361
• 21 U.S.C. § 362
• 21 U.S.C. § 364a
• 21 U.S.C. § 364b
• 21 U.S.C. § 364c
• 21 U.S.C. § 364d
• 21 U.S.C. § 364e
• 21 U.S.C. § 364h
• 15 U.S.C. § 1453
• 21 CFR Part 701
• 21 CFR Part 740
• 21 CFR Parts 73, 74, 81, and 82
• Federal Register search — cosmetic fragrance-allergen labeling

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.