Online Labels Forum

gianni -

The FDA's website appears to have a lot of information related to whether a product is considered to be a cosmetic or a drug, and the labeling requirements for both. Please see the links below:

Are all "personal care products" regulated as cosmetics? Are some drugs or "cosmeceuticals"?
http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/ucm136560.htm

Is it a Cosmetic, a Drug, or Both?
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm

Cosmetic Labeling Guide
http://www.fda.gov/Cosmetics/Labeling/default.htm

Federal Regulations for Over-The-Counter Drug Labeling
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=58749a5c0e679e98398bf80ec3d738de&rgn=div8&view=text&node=21:4.0.1.1.2.3.1.6&idno=21

Hopefully these resources will help you properly classify and label your lip balm products.

Yes the FDA has clear rules. Here is what I add for most of my products: if you sell anywhere on line I also add please don't use if you are sensitive to products, allergies, etc.

Discontinue use if any adverse reactions and consult physician. These statements have not been evaluated by the FDA. The use of herbs or oils for the prevention or cure of disease has not been approved by the FDA or USDA. These products are not intended to diagnose, treat, cure, or prevent any disease.

Hope this is helpful. :)