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SPL v2

SPL

SPL Set ID 374e1c8e-5c5c-9198-e063-6294a90a3b88

Route

TOPICAL

Published

Effective Date 2021-04-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-04-19

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: 2026-02-15T12:07:36.008412 · Updated: 2026-03-14T23:11:14.961491