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SPL v2

SPL

SPL Set ID 35330a82-dc6b-49af-e063-6394a90af9ea

Route

TOPICAL

Published

Effective Date 2023-07-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-07-06

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: 2026-02-15T12:07:38.741534 · Updated: 2026-03-14T23:11:20.857564