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Lip care
All Containers›Shop by use case›Lip care›Cosmetic or drug›Staying a cosmetic on purposeShop all lip care →
Cosmetic or drug

Staying a cosmetic on purpose

By Dwight Davis, Founder

Updated

On this page5

The other route, and the right one for many people starting out: decide the product is a cosmetic and write everything so that it is.

It is a legitimate choice

A cosmetic lip balm is not a lesser product or a loophole. It is a product sold for what it is rather than for a condition it treats, and that is an ordinary and long-standing category.

It keeps you out of establishment registration, the NDC, drug listing and cGMP, which together are the difference between a craft operation and a pharmaceutical one.

What you can still say

What it is made of, and where the material came from. Beeswax from a named apiary is a real differentiator and it is a fact, not a claim.

How it feels and behaves. Rich, glossy, melts on contact, does not slide off.

How it is made. Small batches, hand poured, a named date.

What it smells or tastes of.

What it is for in the ordinary sense: a lip product, for lips, applied as often as you like.

What has to go

Chapped. Cracked. Dry. Heal, repair, restore, treat, soothe, relieve. Protects from wind and cold. Any reference to SPF or sun. Cold sores, of course. And the before-and-after photograph, which is a claim with no words in it.

The hardest one to give up is "dry lips", because it names the customer rather than the product and feels innocent. It is the indication in the monograph.

Keeping it that way

The label is the easy part. The claim escapes through the product page headline, the market sign, the answer to a customer who asks what it is good for, and the review you reposted.

So write the permitted language once, use it everywhere, and give whoever staffs a market stall the same sentence to say.

And remember the obligation that does not go away: safety substantiation has no small-business exemption, cosmetic or not. Staying a cosmetic removes the drug regime, not the responsibility for the product being safe.

References

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
US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.gov
US Food and Drug Administration. Small Businesses & Homemade Cosmetics: Fact Sheet. fda.gov
US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.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.