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SPL v2

SPL

SPL Set ID 364b6af2-a0ed-4a17-e063-6394a90a3a17

Route

TOPICAL

Published

Effective Date 2019-08-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-08-05

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": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARETH-20", "unii": "YRC528SWUY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "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: 2026-02-15T12:07:35.979505 · Updated: 2026-03-14T23:11:13.760766