FDA cosmetic labeling requirements
Overview of FDA requirements for cosmetic labeling.
- Common name of the product must be displayed prominently on the principal display panel. Example “Moisturizing cream”
- New weight should be appear prominently on the PDP
- Cosmetic Ingredient labelling; all the ingredients used (except flavors and fragrances) must appear on the product label in the order of prominence.
- Name and address of manufacturer or distributor
- Warning statement
- Ingredients name should be according to CFTA or common name of the ingredient
- Cosmetic labeling claim must include the drug claims such as to cure or treat any disease or medical condition.
The FDA has published cosmetic labeling guide summarizing the requirements for 21 CFR 701.2 (cosmetic labeling rule).
FDA cosmetic labeling font size requirements
Font size for Ingredient declaration :
1/16″ and 1/32″ for Labeling surface, less than 12 sq. in.
Font size for Net Contents:
- 1/16″ (PDP less than 5 sq. in.)
- 1/8″ (PDP 5-25 sq. in.)
- 3/16″ (PDP 25-100 sq. in.)
Font size for Warning: 1/16″
For any labeling texts: must use reasonably related Font size to panel size
FDAbasics has over 20 years of experience in consulting services for cosmetic label design and review in compliance with FDA requirements.
Failure comply with FDA labeling requirements may result in the FDA enforcement action such as warning letters, product detention, and product seizure.
Please contact us for more information.