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SPL v2

SPL

SPL Set ID 3765dd17-ffbd-bcf4-e063-6394a90a2c2b

Route

TOPICAL

Published

Effective Date 2023-03-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-21

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": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTYLDODECYL ERUCATE", "unii": "D4N66T98C2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,3,3,3-TETRAFLUOROPROPENE, (1E)-", "unii": "5I2481UOO8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACONTANYL PVP", "unii": "N0SS3Q238D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARETH-20", "unii": "YRC528SWUY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOHEXADECANE", "unii": "918X1OUF1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:41.602581 · Updated: 2026-03-14T23:11:24.964856