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SPL v2

SPL

SPL Set ID 37620171-140d-e096-e063-6294a90af93b

Route

TOPICAL

Published

Effective Date 2022-09-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-09-06

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "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": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.015895 · Updated: 2026-03-14T23:11:14.961491