Home SPL Set DailyMed SPL v7 SPL SPL Set ID df6f642d-0f5b-df38-e053-2995a90ad78c Route TOPICAL Published Effective Date 2022-05-20 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Zinc Oxide (2.478 g) Inactive Ingredients Octyldodecanol Glycerin Heptyl Undecylenate Polysorbate 60 Hydrated Silica Edetate Disodium Anhydrous Carbomer Homopolymer, Unspecified Type Phenylethyl Alcohol Bellis Perennis Water Isohexadecane Phenoxyethanol Caprylyl Glycol Cetyl Alcohol Xanthan Gum Sodium Phosphate, Dibasic, Anhydrous Potassium Chloride Potassium Phosphate, Unspecified Form Palmitoyl Tripeptide-1 Ferrous Oxide Triethoxycaprylylsilane Potassium Sorbate Butylene Glycol Palmitoyl Tetrapeptide-7 Sodium Chloride Citric Acid Monohydrate Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Butyloctyl Salicylate Peg-10 Stearate Polysorbate 20 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Hexylene Glycol Glyceryl Stearate/peg-100 Stearate Sorbitan Isostearate Identifiers & Packaging Pill Appearance Color: brown Marketing Status OTC MONOGRAPH FINAL Active Since 2022-04-29 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 [{"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HEPTYL UNDECYLENATE", "unii": "W77QUB6GXO", "classCode": 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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "2.478", "strengthDenominator": "30", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:00:13.781299 · Updated: 2026-03-14T23:00:36.247175