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The balm itself

Actives, and what adding one does to you

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"Active" means two different things in this category and conflating them is how a cosmetic business finds itself running a drug.

Two meanings of the word

In the drug sense it is a specific thing: an ingredient named in a monograph, at a named concentration, with a stated purpose, declared on a Drug Facts panel.

In the marketing sense it is any ingredient with a story, vitamin E, hyaluronic acid, peptides, botanical extracts.

The second kind is fine in a cosmetic right up to the moment you say what it does.

A monograph active

Adding one at a monograph concentration and labeling it as an active makes the product a drug, with everything that brings: registration, an NDC, listing, Drug Facts and cGMP.

It also rebuilds the formula, because the minimums are high. Petrolatum at 30 percent or cocoa butter at 50 percent is not an addition to a recipe; it is the recipe.

Do it deliberately or not at all. The bad outcome is a balm formulated with 35 percent petrolatum "because it works" and labeled as a cosmetic, a drug in substance, non-compliant on the label, and the maker unaware either had happened.

A cosmetic ingredient with a reputation

Vitamin E is the common case. As an antioxidant protecting the oils it is an ordinary cosmetic ingredient. Described as healing or repairing the lip it is a drug claim.

The ingredient did not change. The sentence did, and the sentence is what FDA reads.

The same applies to every botanical with a folk reputation. You can put calendula in a balm. Saying what calendula does for damaged skin is a different act.

The question to ask first

Before adding anything for its properties rather than its behavior, ask what you intend to say about it. If the honest answer is a benefit, you are choosing the drug regime whether or not you meant to.

If the honest answer is that it belongs in the formula for feel, stability or smell, add it and say that.

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
US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Intended use, established by claims, is what decides. fda.gov
21 CFR Parts 210 and 211, Current Good Manufacturing Practice for finished pharmaceuticals, which apply to OTC monograph drug products with no exemption based on the size of the business. 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.