Some cosmetic products must have specific warning statements on the label.
Bubble bath includes any product that contains a surfactant that acts as a detergent or foaming ingredient and which is added to the bath to make foam or bubbles. The foaming ingredient could be a synthetic detergent OR a lye/oil soap. Bubbling bath bombs which contain a foaming surfactant are considered bubble bath.
Unless bubble bath is CLEARLY labeled for adult use only, it must have a warning label which states:
Caution – Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.
Bubble Bath for Children
When the bubble bath is specifically intended for children, it has additional text required at the end:
Caution – Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children except under adult supervision.
Adult Use Only
If the bubble bath is clearly labeled “For adult use only” or “Keep out of reach of children” then the warning label is not required.
Yoni (Feminine Deodorant) Spray
The term “feminine deodorant spray” means any spray deodorant product whose labeling states or suggests that the product is or could be used in the female genital area or that it may be used all over the body (and therefore including the genital area). This includes any product sold as a “Yoni Spray.”
Any product sold as a feminine deodorant spray must have a warning statement on the product label which states:
Caution—For external use only. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.
Suntan Preparations Without Sunscreen
A “sun tanning preparation” is a gel, cream, liquid or other topical product that is intended to provide a cosmetic effect on the skin (such as moisturizing or conditioning) while tanning OR that gives the appearance of a tan by changing the skin color through the use of color additives approved for that application.
Example: A tanning oil to help moisturize when in the sun.
Because consumers generally use such products at the beach or in a tanning salon, if they aren’t paying attention they could think they are being protected by a sunscreen when they are not. In order to help keep consumers informed, the FDA requires the following warning label on any product sold or promoted as a “sun tanning” type product that does not contain sunscreen:
Warning—This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.
Products Containing AHAs or BHAs
Products containing alpha hydroxy acids can cause sensitivity to the sun. Therefore the FDA requires the following warning to be placed on the label:
Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
Products containing beta hydroxy acids may cause similar sensitivities and should be appropriately tested. It warranted, the following warning should be placed on the label:
Sunburn Alert: This product contains a beta hydroxy acid (BHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
Unsubstantiated Safety Warning
It’s common sense that you should know if your product is safe under normal use and you should have some proof or documentation of how you came to that conclusion. For handcrafters, that normally comes from using only ingredients that are known to be safe.
However, if you DON’T know that your product is safe, you must include the unsubstantiated safety warning on the label:
Warning: The safety of this product has not been determined.
Presentation of Warning Statements
Warning statements must be prominent and conspicuous. That is, they must be able to be easily seen and read by the normal consumer.
The text size must be at least 1/16 inch high.