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SPL v2

SPL

SPL Set ID 361ef750-0f0e-bd01-e063-6294a90a0020

Route

TOPICAL

Published

Effective Date 2019-06-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-06-24

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.802198 · Updated: 2026-03-14T23:11:11.874697