Home SPL Set DailyMed SPL v6 SPL SPL Set ID dfc358a3-c946-bdf2-e053-2995a90aaad9 Route TOPICAL Published Effective Date 2022-05-24 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Zinc Oxide (0.7434 g) Inactive Ingredients Mica Albizia Julibrissin Bark Titanium Dioxide Triceteareth-4 Phosphate Polyglyceryl-6 Polyricinoleate Xanthan Gum Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Dimethicone/peg-10/15 Crosspolymer .alpha.-tocopherol Acetate Triheptanoin Tribehenin Magnesium Potassium Aluminosilicate Fluoride C13-16 Isoparaffin Sodium Chloride Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Dipropylene Glycol Glycerin Argan Oil Triethoxycaprylylsilane Silicon Dioxide Ethylhexylglycerin Stannous Oxide Sodium Benzoate Superoxide Dismutase (saccharomyces Cerevisiae) Sodium Citrate Darutoside Tocopherol Water Dimethicone Cyclomethicone 5 Butyloctyl Salicylate Butylene Glycol Nylon-12 Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Levomenol Edetate Disodium Anhydrous Octyldodecanol Potassium Sorbate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Identifiers & Packaging Pill Appearance Color: brown Marketing Status OTC MONOGRAPH FINAL Active Since 2022-04-26 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": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALBIZIA JULIBRISSIN BARK", "unii": "0J9G6W44DV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", 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"1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "0.7434", "strengthDenominator": "9", "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: 2026-02-15T12:00:58.476198 · Updated: 2026-03-14T23:01:14.422395