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.
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.
Required Labeling Under Monograph M016
Meeting the ingredient limits is only part of conformance. M016 also fixes what the label must say, and a compliant formula carrying non-compliant labeling is still a misbranded product.
Uses
The permitted indications depend on the active ingredient. The main ones are:
- Minor wounds: “temporarily protects minor cuts, scrapes, burns.”
- Chapped or cracked skin: “temporarily protects chapped or cracked skin,” optionally with “helps prevent” or “helps relieve” and references to wind and cold.
- Poison ivy, oak and sumac: “dries the oozing and weeping of poison ivy, oak, sumac.”
- Colloidal oatmeal: “temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, poison ivy, oak or sumac, or insect bites.”
Warnings
- “For external use only” on all products, with narrow exceptions for certain mineral oil and sodium bicarbonate presentations.
- “When using this product do not get into eyes.”
- “Stop use and ask a doctor if condition worsens, or symptoms last more than 7 days or clear up and occur again within a few days.”
- Products indicated for cuts and scrapes must add: “Do not use on deep or puncture wounds, animal bites, or serious burns.”
Directions
Most formulations carry “apply as needed.” Colloidal oatmeal soaks, sodium bicarbonate pastes and soaks, and some ingredients aimed at children carry their own specific directions.
What M016 Means for Your Registration
Conforming to M016 lets you market without a new drug application, but it does not remove the registration obligations. Any establishment manufacturing, packaging or labeling a skin protectant for the US market must register with FDA and list the product, and OTC monograph facilities may owe annual OMUFA fees – current amounts are on our FDA fees page.
- Registration and listing through the FDA Electronic Submissions Gateway – see the OTC drug registration process.
- An NDC number for each listed product.
- A US Agent if the site is outside the United States.
- Annual renewal between October 1 and December 31 – see drug establishment registration renewal.
A formula using an active ingredient outside the M016 list, or outside its stated concentration range, is not an OTC monograph drug and needs a different route to market.
Skin Protectant Drug Products — FAQs
Is zinc oxide diaper rash cream a drug?
What skin protectant active ingredients are FDA-approved OTC?
Ready to Register Your Skin Protectant Products?
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