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SPL v2

SPL

SPL Set ID 365fffa2-b846-7dd3-e063-6394a90a47cb

Route

TOPICAL

Published

Effective Date 2025-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-05-30

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:42.486581 · Updated: 2026-03-14T23:11:27.729526