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SPL v2

SPL

SPL Set ID 326e49b8-e21c-0df0-e063-6394a90a2ebc

Route

TOPICAL

Published

Effective Date 2021-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-12-27

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONOL (2000 CST)", "unii": "T74O12AN6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.788928 · Updated: 2026-03-14T23:11:11.874697