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SPL v2

SPL

SPL Set ID 3530898c-7bdf-6ffe-e063-6394a90aa037

Route

TOPICAL

Published

Effective Date 2021-07-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-06

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)", "unii": "8INO2K35FA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE CROSSPOLYMER", "unii": "UF7620L1W6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONOL (2000 CST)", "unii": "T74O12AN6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.864268 · Updated: 2026-03-14T23:11:19.831195