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SPL v2

SPL

SPL Set ID 36c108f6-a928-0a54-e063-6394a90ae686

Route

TOPICAL

Published

Effective Date 2021-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-23

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:44.132270 · Updated: 2026-03-14T23:11:28.912883