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SPL v2

SPL

SPL Set ID 3545ed3e-b42f-d29d-e063-6394a90a8efe

Route

TOPICAL

Published

Effective Date 2023-08-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-08-28

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-4 ISOSTEARATE", "unii": "820DPX33S7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOPENTASILOXANE", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.866332 · Updated: 2026-03-14T23:11:19.831195