Cosmetic or drug: what you can and cannot claim for a balm

The same jar is a cosmetic or a drug depending on what you say about it. Claim-by-claim wording, the ingredient levels that decide for you, and the EU position.

Two identical jars come off the same pour. One is labelled "rich beeswax balm for very dry hands". The other is labelled "healing eczema balm, natural anti-inflammatory". The first is a cosmetic. The second is an unapproved new drug, and the fact that nothing inside the jar changed is the entire point of this page.

The rule: intended use, not composition

The Federal Food, Drug, and Cosmetic Act defines a cosmetic in section 201(i) as an article intended to be rubbed, poured, sprinkled or sprayed on the body for cleansing, beautifying, promoting attractiveness or altering the appearance. Section 201(g)(1) defines a drug in two limbs: an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and an article intended to affect the structure or any function of the body.

Both definitions turn on the word "intended". Neither mentions ingredients, concentration, packaging or how the product was made. That is why the same formula can sit in either category, and why a maker who changes nothing but their Instagram caption can change their regulatory status by accident. The categories are not exclusive either: an antidandruff shampoo is a cosmetic because it cleans hair and a drug because it treats dandruff, and it has to satisfy both sets of rules.

Where the FDA reads intended use from

Intended use is established from evidence, and the agency has said plainly where it looks. Claims on the packaging, in advertising, on the internet and in promotional material all count. Consumer perception counts, meaning why people buy the thing and what they expect it to do. And ingredients with a well known therapeutic use count, the standard example being fluoride in toothpaste.

For a small maker the label is the least of it. A compliant carton is undone by a product page that says "for eczema" or a pinned post that says "clears my daughter's rash". Everything you publish about the product is part of its labelling in the broad sense.

A claim-by-claim table

The table below is written for balms and salves. "Safely cosmetic" means the wording describes appearance, feel or the physical behaviour of the material. "Borderline" means it is used commercially but is arguable. "Drug" means it puts you in the drug category, intended or not.

Ingredients that make the decision for you

Composition does not create intended use on its own, but some ingredients are so strongly associated with a therapeutic purpose that they invite the conclusion, and a few of them appear routinely in home formulas at exactly the levels the monographs specify. The numbers below are the actual concentration ranges in the relevant United States regulations.

Read that table the right way round. A body balm at 60 percent cocoa butter is not automatically a drug, and neither is a barrier balm at 40 percent petrolatum, because you have not claimed anything therapeutic. What the table tells you is where the risk concentrates. If your formula sits at a monograph active level and your marketing edges towards protection, treatment or relief, you have built a drug product without meaning to. The two ingredient families that most often trip up balm makers are the counterirritants covered on our page about menthol, camphor and other actives, and sun filters, which are dealt with in full under SPF in lip balm.

The ingredients that cannot be an active at all

There is a second list, and it runs the other way. 21 CFR 310.545(a)(18)(i)(B) declares a group of familiar materials not generally recognised as safe and effective as skin protectant actives: shark liver oil, cetyl alcohol, stearyl alcohol, glyceryl stearate, isopropyl palmitate, bismuth subnitrate, boric acid, live yeast cell derivative, and, startlingly for this trade, beeswax. Shark liver oil is often listed as a skin protectant in craft sources; it is not, it is an anorectal active under 21 CFR Part 346.

Read the beeswax finding carefully. It does not restrict beeswax as a cosmetic ingredient, and it says nothing about whether beeswax works as an occlusive. What it means is narrow and absolute: beeswax cannot be the claimed active ingredient of a United States drug product. A balm that is 30 percent beeswax, sold to soften lips, is an unremarkable cosmetic. A balm whose Drug Facts panel names beeswax as the active is an unapproved new drug.

Boils, cold sores and the drawing salve rule

The single strongest rule for anyone selling salves is also the least known. 21 CFR 310.531 provides that any over-the-counter product "labeled, represented, or promoted for the treatment of boils is regarded as a new drug", requiring an approved application before it can be marketed. The rule names the exact palette of a traditional drawing salve: ichthammol, camphor, menthol, methyl salicylate, lanolin, petrolatum, zinc oxide, pine tar and rosin. There is no monograph to comply with and no concentration that makes it legal, which is covered at length in our guide to drawing salves and black salve.

Cold sore products are fenced off in the same way. Under 21 CFR 310.545(a)(10)(v), camphor above 3 percent, menthol above 1 percent, methyl salicylate, eucalyptus oil, turpentine oil, capsaicin and eugenol are all non-GRASE for that use. Eucalyptus oil has no United States OTC monograph status at all, and camphorated oil is a new drug in its own right under 21 CFR 310.502(a)(4).

Sunscreen is a special case

The FDA wrote a rule specifically about this. Under 21 CFR 700.35, a product that includes the term "sunscreen" in its labelling, or otherwise represents that it protects against sun damage, comes within the drug definition, because sunscreen ingredients absorb, reflect or scatter burning rays and so alter the normal physiological response to solar radiation. There is one narrow escape hatch: a cosmetic may contain a filter for a non-therapeutic purpose, such as protecting the colour of the product, provided the term is qualified prominently, in the style of "contains a sunscreen to protect product colour".

The common trap here is the claim that coconut oil is SPF 8, which circulates as settled fact. It traces to a 2010 in vitro ultraviolet spectrophotometric estimate on hydroalcoholic dilutions, not to an in vivo SPF determination on human skin. Repeating the number in your own marketing is not a botanical aside. It is a sun protection claim, and under 21 CFR 700.35 it turns a cosmetic balm into an unapproved new drug.

Testimonials, reposts and before-and-after photographs

Nothing you write about your own product is riskier than what you quote from a customer. Featuring a review that says a salve cleared a child's eczema adopts that claim, and so does resharing it or answering a public comment with "yes, lots of customers use it for that". Before and after photographs of a skin condition are worse again, because they communicate treatment without a single reviewable word.

The workable house rule is that testimonials may describe feel, texture, scent and use occasion, and may not name a condition or describe a cure. If a review you love does both, quote the half that is about texture. Our page on what the evidence actually says about balms and eczema is a useful reality check on why the claims are hard to support even before they are illegal.

What crossing the line actually costs

Being a drug is not a fine, it is a different regime. A monograph over-the-counter product must conform to the monograph exactly, carry a Drug Facts panel in the format of 21 CFR 201.66, be made in a facility registered as a drug establishment with the product listed, and be manufactured under drug current good manufacturing practice. If your product does not fit a monograph, it is an unapproved new drug, which cannot be legally marketed at all. Warning letters to small skincare brands are usually about claims, not chemistry.

How the European Union and United Kingdom handle the same problem

The categories are separate there too, but the machinery differs. Cosmetics fall under Regulation (EC) No 1223/2009, which defines a cosmetic by where it is applied and what it does: cleaning, perfuming, changing appearance, protecting, keeping in good condition, correcting body odours. Medicines fall under Directive 2001/83/EC, which catches a product either by presentation or by function, meaning it restores, corrects or modifies physiological functions. Where both could apply, the medicinal rules take precedence.

On top of that, Article 20 of the cosmetics regulation forbids claims implying characteristics or functions the product does not have, and Regulation (EU) No 655/2013 sets six common criteria that every cosmetic claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision making. The evidential support criterion is the one that bites hardest on small brands, because claims must be "supported by adequate and verifiable evidence" held in the product information file. The practical implication for anyone selling balms in the United Kingdom or European Union is that even a legal cosmetic claim needs a paper trail behind it.

A house style that keeps you out of trouble

Write about the material, not the body. A balm is an anhydrous film of wax, butter and oil; describe what that film does physically and let the reader draw the conclusion. "Forms a thick, slow-melting film that holds up to washing up" is a stronger sentence than "heals damaged hands", and it is true. Where a claim depends on an ingredient's reputation rather than the finished product, cut it: our note on comedogenic ratings covers a term that is neither regulated nor measured, and the same caution applies to "clinically proven" and "dermatologist tested" unless you hold the study.

Three habits are worth building now. Keep a claims file listing every claim and the evidence behind it, which is required in the EU and useful everywhere. Review your social media the way a regulator would, oldest posts first. And decide once, in writing, whether you are a cosmetic brand or a drug brand, because half the compliance problems in this trade come from selling a cosmetic while talking like a pharmacy. The mechanics of the label itself are in US cosmetic labelling.

If you want to sell something that genuinely relieves aching muscles or clears a chest, the answer is not better wording. It is either to accept drug status and its costs, or to sell the product for what it is. The recipes here for a muscle rub balm, a chest rub balm and a nappy rash balm are written for personal and family use because the commercial versions are drugs in most markets, and a nipple balm sits in the same awkward space.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.