Cosmetic or drug

The actives the monograph allows

Updated October 2026

On this page5

A closed list The ones that matter for lip balm What is NOT on the list Combinations References

If the product is going to be a lip protectant drug, the active has to come from one list, at a concentration the list sets.

A closed list

21 CFR 347.10 names the skin protectant actives and the range for each. It is not a starting point or a set of examples. Anything else is an unapproved new drug.

The ones that matter for lip balm

White petrolatum or petrolatum, 30 to 100 percent.

Cocoa butter, 50 to 100 percent.

Hard fat, 50 to 100 percent.

Lanolin, 12.5 to 50 percent.

Mineral oil, 50 to 100 percent.

Dimethicone, 1 to 30 percent.

Allantoin, 0.5 to 2 percent.

Glycerin, 20 to 45 percent.

Read the concentrations. Cocoa butter at 50 percent minimum is not a flavor note, it is most of the formula, and a balm built to that number is a different product from one with cocoa butter as a fifth ingredient.

What is NOT on the list

Beeswax. Shea butter. Coconut oil. Jojoba. Candelilla. Carnauba. Vitamin E.

Which is the finding that surprises people, because those six are what an artisan lip balm is actually made of. A balm built from them cannot carry a lip protectant claim, however well it works.

That is not a judgment about the ingredients. The monograph is a list of actives reviewed for a specific indication, and these were not submitted for it.

Combinations

347.20 says which actives may be combined and how the result must be labeled. Two or more from the relevant group, each within its own concentration range, labeled to the matching indication.

Combining a skin protectant with a sunscreen is dealt with separately, in 347.20(d) and in the sunscreen monograph, and is a common combination in this category.

The practical consequence: an active is not an additive you drop into an existing recipe. Meeting a minimum of 30 or 50 percent rebuilds the formula around it.

References

21 CFR 347.10, Skin protectant active ingredients. A closed list at fixed concentrations, including allantoin 0.5–2%, cocoa butter 50–100%, dimethicone 1–30%, glycerin 20–45%, hard fat 50–100%, lanolin 12.5–50%, mineral oil 50–100%, petrolatum and white petrolatum 30–100%. ecfr.gov

21 CFR 347.20, Permitted combinations of active ingredients. Which monograph actives may be combined, and with what labeling. Combinations of a skin protectant with a sunscreen are addressed in 347.20(d) and in the sunscreen monograph. ecfr.gov

21 CFR 347.3, Definitions. "Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called ‘lip balm.’" ecfr.gov

Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.