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SPL v2

SPL

SPL Set ID 35425e24-3e2c-51db-e063-6394a90a5580

Route

TOPICAL

Published

Effective Date 2023-10-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Alpha-tocopherol Acetate Water Peg-10 Dimethicone (600 Cst) C12-15 Alkyl Benzoate Cyclohexasiloxane Dimethicone Edetate Disodium Anhydrous Glycerin Sodium Chloride Microcrystalline Wax Polysorbate 20 Tetrahexyldecyl Ascorbate Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Dimethiconol (2000 Cst) Peg-30 Dipolyhydroxystearate Triethoxycaprylylsilane Cyclopentasiloxane Stearyl Dimethicone (400 Mpa.s At 50c) Triethanolamine Dimethicone Crosspolymer Hydrogen Dimethicone (20 Cst) Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 Mw) Caprylhydroxamic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-10-27

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.560954 · Updated: 2026-03-14T23:11:23.873993