Home SPL Set DailyMed SPL v1 SPL SPL Set ID 41cca42f-3d2a-9a32-e063-6394a90a03e1 Route CUTANEOUS Published Effective Date 2025-09-01 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Homosalate (4.75 g) Ethylhexyl Salicylate (2.5 g) Titanium Dioxide (1 g) Butyl Methoxydibenzoylmethane (1.5 g) Ethylhexyl Methoxycinnamate Octocrylene Inactive Ingredients Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Tocopheryl Retinoate Hydrated Silica Microcrystalline Wax C12-15 Alkyl Benzoate Beeswax Butyl Acrylate/c16-c20 Alkyl Methacrylate/methacrylic Acid/methyl Methacrylate Copolymer Identifiers & Packaging Pill Appearance Color: green Marketing Status OTC MONOGRAPH DRUG Active Since 2025-09-01 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 51727-6 Section 51945-4 Section 55105-1 Structured Label Content Indications and Usage (34067-9) Dosage and Administration (34068-7) Warnings and Precautions (34071-1) Section 50565-1 (50565-1) Section 51727-6 (51727-6) Section 51945-4 (51945-4) Section 55105-1 (55105-1) Advanced Ingredient Data [{"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "4.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL SALICYLATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BUTYL METHOXYDIBENZOYLMETHANE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)", "unii": "587WKM3S9Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL METHOXYCINNAMATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TOCOPHERYL RETINOATE", "unii": "0WN694NBMM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER", "unii": "7K68DGG29P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:08:46.945006 · Updated: 2026-03-14T23:13:09.195902
