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SPL v1

SPL

SPL Set ID 37624bf6-4949-1b10-e063-6294a90ac488

Route

TOPICAL

Published

Effective Date 2022-09-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (30 mg) Titanium Dioxide (100 mg)

Inactive Ingredients

Caprylhydroxamic Acid Glyceryl Stearate Octyldodecyl Neopentanoate Polyhydroxystearic Acid (2300 Mw) 1,3,3,3-tetrafluoropropene, (1e)- Triethoxycaprylylsilane Cellulose Gum Ceteareth-20 Glycereth-26 Edetate Disodium Anhydrous Cetearyl Alcohol Citric Acid Poly(methyl Methacrylate; 450000 Mw) Butyloctyl Salicylate Triacontanyl Pvp Caprylyl Glycol Isododecane Microcrystalline Cellulose Octyldodecyl Erucate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Polysorbate 80 Water C12-15 Alkyl Benzoate Isohexadecane Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-09-06

Medication Information

Section 51945-4

Structured Label Content

Section 51945-4 (51945-4)

Advanced Ingredient Data

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450000 MW)", "unii": "Z47NNT4J11", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACONTANYL PVP", "unii": "N0SS3Q238D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISODODECANE", "unii": "A8289P68Y2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTYLDODECYL ERUCATE", "unii": "D4N66T98C2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOHEXADECANE", "unii": "918X1OUF1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.888236 · Updated: 2026-03-14T23:08:59.288880