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SPL v2

SPL

SPL Set ID 364ae392-480a-14ea-e063-6394a90a3883

Route

TOPICAL

Published

Effective Date 2021-06-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-07

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:30.879822 · Updated: 2026-03-14T23:11:04.312793