US Skincare Labeling Checklist: INCI, Net Contents, Warnings (21 CFR 701)

For skincare brands planning to enter or expand in the U.S. market, proper cosmetic labeling under 21 CFR 701 is non‑negotiable. A compliant label protects both your product and your business—building trust with retailers, regulators, and consumers alike. Use this guide to check your packaging artwork, ingredient lists, and regulatory statements before print or market release.

Key Labeling Obligations Under 21 CFR 701

• Identity Statement: Clearly identify what the product is (e.g., “Facial Moisturizer” or “Sunscreen Lotion”) on the principal display panel.
• Net Contents: Must declare the quantity of contents in U.S. customary and metric units (e.g., “3 fl oz (89 mL)”).
• Ingredient Declaration (INCI): All ingredients must be listed by their International Nomenclature of Cosmetic Ingredients (INCI) names in descending order of predominance.
• Manufacturer or Distributor Name and Address: Include the responsible party’s full name and business address, and identify the relationship with terms like “Manufactured by” or “Distributed by.”
• Warnings and Cautions: Include specific cautionary statements when required (e.g., for aerosol products, products intended for the eye area, or those containing alpha‑hydroxy acids).

INCI Naming and Common Pitfalls

INCI names are standardized and recognized globally. Ensuring every ingredient uses its correct INCI term is essential for regulatory acceptance and export readiness.

Tips for Buyers

• Cross‑check your ingredient list against the latest Personal Care Products Council (PCPC) dictionary or a validated INCI database.
• Ask your manufacturer for the full formulation sheet and verify that the INCI order aligns with weight‑based predominance.
• For color additives, confirm each appears on the FDA’s approved list for cosmetic use.

Net Quantity and Dual Unit Requirements

Ensure the quantity appears on the lower portion of the principal display panel and uses both U.S. customary and metric units. For solids and semi‑solids, use “net wt” (weight); for liquids, use “fl oz” (volume).

Warning Statements You Shouldn’t Miss

• Eye Area Products: “Avoid contact with eyes.”
• Aerosol Sprays: “Flammable—do not use near heat or flame.”
• Alpha‑Hydroxy Acid (AHA) Products: Include sunburn alert if applicable.
• Children’s Products: Include age‑appropriate use instructions.

Always validate warnings against your final formulation and product form—changing a perfume level, pH, or preservative may alter required warnings.

Pre‑Print Review Checklist

• Confirm spelling of all INCI names and consistency with formula documentation.
• Verify net content placement and type size relative to label dimensions.
• Ensure required warning statements are clearly visible and contrast sufficiently against the background.
• Check that distributor and manufacturer information matches business licenses and facility registration details.
• Archive label proofs and mock‑ups for at least three years as part of your product technical file.

Documentation to Request from Your Manufacturer

• Full formulation list with INCI nomenclature and concentration ranges.
• Certificate of Analysis (COA) for batch validation.
• Stability and microbiological test results supporting primary shelf life.
• Copy of most recent facility registration (for traceability).
• Label artwork approval record signed by QA and regulatory staff.

Frequently Asked Questions

1. Do I need to include both English and metric units on the label?

Yes. U.S. regulations require dual declaration. Skipping either can cause detention at customs or retailer rejection.

2. Is an ingredient list mandatory for all skincare products?

All cosmetics sold at retail must list ingredients unless exempt (e.g., for certain professional‑use bulk shipments). For e‑commerce, the same rule applies on consumer‑visible labeling.

3. Can I use trade names instead of INCI names?

No. Trade names or marketing names (e.g., “Pro‑Collagen X™”) are not acceptable in the ingredient list. They may appear elsewhere in marketing copy but must not replace standardized INCI names.

4. How can I verify a label’s compliance before printing?

Request a final regulatory artwork review from your manufacturer or an independent consultant. Use the CFR §701 checklist to confirm each mandatory element appears on the correct panel.

5. What are common labeling penalties?

Improper ingredient declaration or misleading claims can result in product seizure, import refusal, or warning letters. Keeping a compliant master label file minimizes risk.

Next step: Before final production, share your draft label with your contract manufacturer’s regulatory team to cross‑verify every element. Clear documentation today prevents rework tomorrow.

Request a Quote to align formulation, packaging, and label compliance for your U.S. skincare launch.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.