The general warning duty
Updated
On this page8
What it says
The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product. No enumerated triggers, no thresholds.
Which makes it a judgment
And the judgment is yours, informed by the safety substantiation you were already required to do. The two rules work together: the substantiation tells you what the hazards are and this one asks you to warn about them.
Bath products have obvious candidates
A slippery tub from an oil, essential oils on sensitive skin, a hot shower steamer being handled, a product not intended for use on broken skin. None of those has a prescribed sentence and all of them are plausible warnings.
Slip is the one most often missed
A bath oil or a milk bath leaves a tub slick, and that is a fall risk for exactly the people most likely to use a long soak. A line about it is appropriate and costs nothing.
Essential oils are the second
Loading, sensitization and photosensitivity for citrus oils are real, and a bath distributes the oil over the whole body in warm water. That is a higher exposure than a leave-on product at the same percentage.
The Commissioner can prescribe more
The regulation provides for proposing new warnings, on the Commissioner’s initiative or on a petition with an adequate factual basis. So the list of specific cosmetic warnings is not closed.
Write the warnings you believe in
A warning that reflects a hazard you identified reads as considered. A page of borrowed boilerplate reads as borrowed, and it does not discharge a duty framed around your product.