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SPL v2

SPL

SPL Set ID 325df1f8-1678-c07c-e063-6294a90a96fb

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

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

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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"IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOHEXASILOXANE", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOPENTASILOXANE", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": 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{"name": "PEG-30 DIPOLYHYDROXYSTEARATE", "unii": "9713Q0S7FO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.788342 · Updated: 2026-03-14T23:11:11.874697