Home SPL Set DailyMed SPL v2 SPL SPL Set ID 32351db0-884c-8fa0-e063-6294a90acba2 Route TOPICAL Published Effective Date 2024-10-14 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Zinc Oxide (55 mg) Titanium Dioxide (40 mg) Inactive Ingredients Cetyl Dimethylbutyl Ether Ethylene Brassylate Polyhydroxystearic Acid (2300 Mw) Alpha-tocopherol Acetate Ethylhexyl Palmitate Hexyldecanol C12-15 Alkyl Benzoate Hexyldecyl Laurate Ceresin Propylene Glycol Dicaprylate/dicaprate Stearic Acid Zingiber Officinale (ginger) Root Oil Ci 77492 Ci 77499 Polyglyceryl-3 Diisostearate Aluminum Hydroxide Ci 77491 Lecithin, Soybean Ascorbic Acid Ascorbyl Palmitate Cetearyl Isononanoate Tocopherol Helianthus Annuus (sunflower) Seed Wax Peg-8 Aluminum Stearate Peg/ppg-15/15 Dimethicone Citric Acid Identifiers & Packaging Marketing Status OTC MONOGRAPH DRUG Active Since 2024-10-14 Medication Information Section 51945-4 Structured Label Content Section 51945-4 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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CI 77491", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBYL PALMITATE", "unii": "QN83US2B0N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARYL ISONONANOATE", "unii": "P5O01U99NI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX", "unii": "42DG15CHXV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-8", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM STEARATE", "unii": "U6XF9NP8HM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG/PPG-15/15 DIMETHICONE", "unii": "184IZ28A2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "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: 2026-02-15T12:07:32.616594 · Updated: 2026-03-14T23:11:07.873139
