FDA cosmetic labeling requirements FDAbasics

Overview of  FDA cosmetic labeling requirements

 

FDA cosmetic labeling requirements

Here is a list of  FDA cosmetic labeling requirements

  • The common name of the product must be displayed prominently on the principal display panel. Example “Moisturizing cream”
  • New weight should appear prominently on the PDP
  • Cosmetic Ingredient labeling; 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 the 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 a cosmetic labeling guide summarizing the requirements for 21 CFR 701.2 (cosmetic labeling rule).

 

Incorrect labeling may result in the detention of your shipments at the port of entry.  

 

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 to comply with FDA labeling requirements may result in FDA enforcement action such as warning letters, product detention, and product seizure.

Please contact us for more information.

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