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SPL v2

SPL

SPL Set ID 338a11fb-24c6-8a0b-e063-6294a90a761e

Route

TOPICAL

Published

Effective Date 2023-03-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-31

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:40.559427 · Updated: 2026-03-14T23:11:23.873993