DailyMed - DailyMed Details

SPL v2

SPL

SPL Set ID dc876b06-bc4e-3a00-e053-2a95a90afa6e

Route

TOPICAL

Published

Effective Date 2022-05-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (2.478 g)

Inactive Ingredients

Titanium Dioxide Tocopherol Sodium Phosphate, Dibasic, Anhydrous Ferrous Oxide Acrylic Acid/2-ethylhexyl Acrylate/styrene Copolymer (500000 Mw) Propylene Carbonate Edetate Disodium Anhydrous C13-16 Isoparaffin Mannitol Silicon Dioxide Acetyl Tetrapeptide-9 Palmitoyl Tripeptide-1 Butylene Glycol Peg-9 Polydimethylsiloxyethyl Dimethicone Alkyl (c12-15) Benzoate Isododecane Caprylyl Glycol Triethoxycaprylylsilane Ethyl Glycolate Butyloctyl Salicylate Triheptanoin C18-36 Acid Triglyceride Dimethicone/peg-10/15 Crosspolymer Dimethicone Alcohol Palmitoyl Tetrapeptide-7 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Water Glycerin Bellis Perennis Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Quaternium-90 Bentonite Alpha-tocopherol Acetate Sodium Chloride Potassium Sorbate Triceteareth-4 Phosphate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Polyglyceryl-3 Diisostearate Argan Oil Polyglyceryl-6 Polyricinoleate Xanthan Gum Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sorbitan Monolaurate Octyldodecanol Levomenol Hexylene Glycol Dipropylene Glycol Phenylethyl Alcohol Sodium Citrate Potassium Chloride Potassium Phosphate, Dibasic

Identifiers & Packaging

Pill Appearance

Color: white Color: brown

Marketing Status

OTC MONOGRAPH FINAL Active Since 2022-04-13

Medication Information

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Advanced Ingredient Data

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Source: dailymed · Ingested: 2026-02-15T12:01:02.192155 · Updated: 2026-03-14T23:01:14.422395