36d9d83b-7da5-a006-e063-6394a90a9d84

SPL v2

SPL

SPL Set ID 36d9d83b-7da5-a006-e063-6394a90a9d84

Route

topical

Published

Effective Date 2024-09-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (200 mg)

Inactive Ingredients

sodium chloride dimethiconol (2000 cst) caprylyl glycol microcrystalline wax polyhydroxystearic acid (2300 mw) triethoxycaprylylsilane water triethanolamine dimethicone/vinyl dimethicone crosspolymer (soft particle) peg-10 dimethicone (600 cst) cetyl peg/ppg-10/1 dimethicone (hlb 4) cyclopentasiloxane dimethicone dimethicone crosspolymer polysorbate 20 alpha-tocopherol acetate c12-15 alkyl benzoate glycerin polyglyceryl-4 isostearate caprylhydroxamic acid cyclohexasiloxane hydrogen dimethicone (20 cst) peg-30 dipolyhydroxystearate stearyl dimethicone (400 mpa.s at 50c) tetrahexyldecyl ascorbate edetate disodium anhydrous

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-09-27

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthDenominatorUnit": ""}, {"name": "CYCLOHEXASILOXANE", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-30 DIPOLYHYDROXYSTEARATE", "unii": "9713Q0S7FO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL DIMETHICONE (400 MPA.S AT 50C)", "unii": "R327X197HY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:41.096843 · Updated: 2026-03-14T23:11:24.964856