FDA Registration for Skin Protectant Drug Products

Skin protectant products containing zinc oxide, petrolatum, dimethicone, or other permitted active ingredients are regulated as OTC Monograph drugs by FDA.

OTC MonographDrug Facts Required21 CFR Part 207Since 2009

FDA Requirements for Skin Protectant Drug Products

Skin protectant OTC drug products protect and prevent chapped skin, diaper rash, and minor skin irritations. Permitted active ingredients include petrolatum (30–100%), zinc oxide (1–25%), and dimethicone (1–30%).

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

The FDA established an OTC monograph, M016, to regulate over-the-counter (OTC) skin protectant drugs. This ensures these topical products are safe and effective for minor skin conditions. The monograph outlines acceptable ingredients, like allantoin for “temporarily protecting chapped or cracked skin” or zinc oxide to dry the oozing and weeping of poison ivy, oak or sumac. It also dictates labeling requirements, so you can be confident about using the product as intended. This applies to common skin irritations like scrapes, dryness, and insect bites.

M016.10 Skin protectant active ingredients

Active Ingredients	OTC Monograph Number
Allantoin, 0.5 to 2 percent	M016.10 (Part 347)
Aluminum hydroxide gel, 0.15 to 5 percent	M016.10 (Part 347)
Calamine, 1 to 25 percent	M016.10 (Part 347)
Cocoa butter, 50 to 100 percent	M016.10 (Part 347)
Cod liver oil, 5 to 13.56 percent	M016.10 (Part 347)
Colloidal oatmeal, 0.007 percent minimum	M016.10 (Part 347)
Dimethicone, 1 to 30 percent	M016.10 (Part 347)
Glycerin, 20 to 45 percent	M016.10 (Part 347)
Hard fat, 50 to 100 percent	M016.10 (Part 347)
Kaolin, 4 to 20 percent	M016.10 (Part 347)
Lanolin, 12.5 to 50 percent	M016.10 (Part 347)
Mineral oil, 50 to 100 percent	M016.10 (Part 347)
Lanolin, 15.5 percent	M016.10 (Part 347)
Sodium bicarbonate	M016.10 (Part 347)
Talc,45 to 100 percent	M016.10 (Part 347)
Topical starch, 10 to 98 percent	M016.10 (Part 347)
White petrolatum, 30 to 100 percent	M016.10 (Part 347)
Zinc acetate 0.1 to 2 percent	M016.10 (Part 347)
Zinc carbonate, 0.2 to 2 percent	M016.10 (Part 347)
Zinc oxide, 1 to 25 percent	M016.10 (Part 347)
Zinc oxide, above 25 to 40 percent in an ointment dosage form.	M016.10 (Part 347)

M016.12 Astringent active ingredients

Active Ingredients	OTC Monograph Number
Aluminum acetate, 0.13 to 0.5 percent	M016.12 (Part 347)
Aluminum sulfate, 46 to 63 percent	M016.12 (Part 347)
Witch hazel	M016.12 (Part 347)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.