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SPL v2

SPL

SPL Set ID 387b41a4-057f-88af-e063-6394a90adbbe

Route

TOPICAL

Published

Effective Date 2025-06-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-03

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-10 DIMETHICONE (600 CST)", "unii": "8PR7V1SVM0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-4 ISOSTEARATE", "unii": "820DPX33S7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)", "unii": "9E4CO0W6C5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONOL (2000 CST)", "unii": "T74O12AN6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:33.277878 · Updated: 2026-03-14T23:11:08.891584