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SPL v2

SPL

SPL Set ID 3764cbeb-55f5-4a9c-e063-6394a90a863d

Route

TOPICAL

Published

Effective Date 2022-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-06-10

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:41.599826 · Updated: 2026-03-14T23:11:24.964856