369a8a99-c755-3c7f-e063-6394a90ac16c

SPL v2

SPL

SPL Set ID 369a8a99-c755-3c7f-e063-6394a90ac16c

Route

topical

Published

Effective Date 2025-04-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (200 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-04-09

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHEXYLDECYL ASCORBATE", "unii": "9LBV3F07AZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)", "unii": "8INO2K35FA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN DIMETHICONE (20 CST)", "unii": "12Z59IF64N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL DIMETHICONE (400 MPA.S AT 50C)", "unii": "R327X197HY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-30 DIPOLYHYDROXYSTEARATE", "unii": "9713Q0S7FO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOHEXASILOXANE", "unii": "XHK3U310BA", "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: 2026-02-15T12:07:41.088359 · Updated: 2026-03-14T23:11:24.964856