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The cosmetic half

Aloe, after sun and self tanner

Updated

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Three of the six products on this shelf are ordinary cosmetics, and that is where most small makers can actually operate.

What a cosmetic carries

The identity of the product, net quantity, the ingredient declaration in the cosmetic convention, the responsible party, and any warnings the product needs. No pre-market approval, no mandated effectiveness testing, no Drug Facts panel.

Which makes it the accessible end of the shelf

An aloe gel or an after sun lotion can be formulated, labeled and sold without entering a drug or pesticide regime at all. For somebody who wants to serve this market without the sunscreen problem, this is the product to make.

Self tanner is a cosmetic with a specific active

The color comes from a reaction at the skin surface rather than from a dye, and the product is a cosmetic. It also tends to attract claims about protection that it cannot support, which is the next page.

Tanning oil is the one to think about

A product intended to promote tanning sits in an awkward place commercially and sometimes regulatorily, particularly if it carries any SPF claim, because an SPF claim is a sunscreen claim and brings the whole drug regime with it.

After sun is where drug claims creep in

The natural things to say about a product for skin after sun exposure, about healing or repairing or treating a burn, are drug claims. Soothing and moisturizing are cosmetic. The distance between those two vocabularies is the whole discipline.

The container is identical

All of these use the same bottles and pumps as the sunscreen next to them, which is why the shelf is shared. Nothing about the packaging tells you which regime a product is in.

Staying a cosmetic is a strategy, not a limitation

A maker who deliberately keeps every claim inside cosmetic territory can build a real range on this shelf without testing, panels or registration. That is a legitimate position and it has to be defended sentence by sentence.

References

21 CFR 701, Cosmetic Labeling, for the products on this shelf that are cosmetics rather than drugs or pesticides. law.cornell.edu
21 CFR 201.327, Over-the-counter sunscreen drug products; required labeling based on effectiveness testing. Paragraph (g) makes “sunblock”, “sweatproof” and “waterproof” false or misleading; paragraph (a)(2) permits only “Water Resistant (40 minutes)” or “(80 minutes)”; paragraph (d)(2) carries the Skin Cancer/Skin Aging Alert. law.cornell.edu
Written from federal regulation, not from a formulation lab. A sunscreen is an OTC drug and an insect repellent is a pesticide, and both carry requirements that a cosmetic does not. Nothing here clears a specific label, and the difference between a cosmetic claim and a drug claim is narrower than it looks.