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SPL v2

SPL

SPL Set ID 351f06f3-9deb-4c1a-e063-6394a90ad766

Route

TOPICAL

Published

Effective Date 2024-06-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-19

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "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: 2026-02-15T12:07:38.736009 · Updated: 2026-03-14T23:11:20.857564