Skin Protectants
A product that is intended to protect the skin (a "skin protectant") is a drug. The class of skin protectants includes products identified as skin protectants, lip protectants, poison ivy, oak or sumac protectant, and fever blister/cold sore treatments. In some cases, skin protectants may also provide minor treatment such as drying out poison ivy reactions or helping to relieve dry, cracked skin or lips.
If you make any claims that make the consumer think that the intended use of the product is to protect the skin, then the product is a drug.
Skin Protectant Products
There are many non-prescription skin protection products on the market that look like cosmetics but are, in fact, over-the-counter drugs. For example, a lip product that is intended to protect against chapped lips is a skin protectant, while a lip product that moisturizes the lips is a cosmetic product.
The claims that may be made for skin protectants depend on which of the allowed ingredients are used. Some examples based on the allowed wording options for the products’ intended use are:
- Temporarily products minor cuts, scrapes and burns
- Helps prevent chapped or cracked skin
- Temporarily protects chapped lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Dries oozing and weeping of poison ivy, oak and sumac
- Temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac or insect bites
- Temporarily protects and helps relieve minor skin irritation
- Helps treat diaper rash
In order to be marketed as a skin protectant the product must meet the OTC Monograph for skin protectant products, using only approved ingredients, label claims, directions, and warning statements.
Reality vs Regulation
Many of the approved ingredients for use in skin protectants are ones that are commonly used in handcrafted cosmetics, such as cocoa butter, colloidal oatmeal, glycerin, hard fat, kaolin clay, lanolin, starch, baking soda, and zinc oxide.
However, rightly or wrongly, even if you could formulate a product that meets the OTC monograph requirements, you would still need to meet all of the drug manufacturing requirements in order to make any skin protectant claims for it.
In order for a drug to be legally marketed it must be manufactured in a facility that is registered as a drug manufacturer with the FDA and in which follow drug good manufacturing practices as contained in federal regulations are followed. It is likely there are state-level drug manufacturing registration and licensing requirements.
