Three regulators, one shelf
Updated
On this page8
Sunscreen: FDA, as a drug
An over-the-counter drug, with a Drug Facts panel, an SPF that comes from testing rather than formulation arithmetic, and a specific regulation listing words you may not print. That is the heaviest regime on this shelf by a wide margin.
Insect repellent: EPA, as a pesticide
A skin-applied repellent is a pesticide under FIFRA, registered with the Environmental Protection Agency and carrying a registration number. EPA describes that number as meaning the company provided technical information on the product’s safety and effectiveness. Different agency, different vocabulary, different timeline.
Aloe, after sun, self tanner: FDA, as cosmetics
Much lighter. No pre-market approval, no mandated panel of the Drug Facts kind, and the labeling requirements a cosmetic carries. This is where most small makers on this shelf actually sit.
And you can move between them with a sentence
An aloe gel that says it soothes is a cosmetic. The same gel claiming to treat a burn is making a drug claim. A citronella candle oil that says it repels mosquitoes is making a pesticidal claim. The product did not change; the regime did.
Which is why the claim comes before the formulation
Deciding what you intend to say determines which regulator you are dealing with, and therefore what testing, what panel and what timeline you are committing to. Working the other way round is how people discover late that they have built a drug.
The container is the easy part
All three go in substantially the same bottles with the same pumps, which is why they share a shelf. The container section is short for that reason and the regulatory sections are not.
Pick the regime before the product name
Names are the hardest thing to change later and they frequently carry the claim. Deciding which of the three regimes you intend to be in, and then naming into it, saves the most expensive kind of rework.