Home SPL Set DailyMed SPL v3 SPL SPL Set ID 42c74ddf-70a3-f2b1-e063-6294a90a91a9 Route TOPICAL Published Effective Date 2025-11-01 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Ensulizole (1 mg) Homosalate (13 mg) Octisalate (2 mg) Avobenzone (14 mg) Octocrylene (5 mg) Inactive Ingredients Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Cetyl Alcohol Decylene Glycol Beeswax Phenoxyethanol Water Carbomer Magnesium Disodium Edta Sodium Stearoyl Lactylate Sodium Hydroxide Glyceryl Stearate Citrate Caprylyl Glycol Ethylhexyl Isononanoate Peg-100 Hydroxyacetophenone Identifiers & Packaging Marketing Status OTC MONOGRAPH DRUG Active Since 2025-11-01 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": "ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)", "unii": "8Z5ZAL5H3V", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "DECYLENE GLYCOL", "unii": "S57M60MI88", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "13", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CARBOMER", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "MAGNESIUM DISODIUM EDTA", "unii": "NDT563S5VZ", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SODIUM STEAROYL LACTYLATE", "unii": "IN99IT31LN", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERYL STEARATE CITRATE", "unii": "WH8T92A065", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ETHYLHEXYL ISONONANOATE", "unii": "I6KB4GE3K4", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "PEG-100", "unii": "TVH7653921", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ENSULIZOLE", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "14", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "9", "strengthDenominator": "60", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:08:54.874570 · Updated: 2026-03-14T23:13:23.763125
