Home SPL Set DailyMed SPL v1 SPL SPL Set ID 485d31e4-a2a9-8165-e063-6294a90a14fc Route TOPICAL Published Effective Date 2026-01-14 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Homosalate (0.05 g) Ethylhexyl Salicylate (0.03 g) Butyl Methoxydibenzoylmethane Inactive Ingredients Phenoxyethanol Avena Sativa (oat) Starch Benzoic Acid Polysorbate 60 Butyloctyl Salicylate Jojoba Oil Glycereth-2 Cocoate Sorbitan Isostearate Aloe Barbadensis Leaf Juice Shea Butter Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Oryza Sativa (rice) Bran Ethylhexylglycerin Sodium Benzoate Hordeum Vulgare Whole Rosmarinus Officinalis (rosemary) Leaf Oil Pentylene Glycol Tocopherol C12-15 Alkyl Benzoate Hydrated Silica Ethyl Ferulate Water Citric Acid Helianthus Annuus (sunflower) Seed Oil Glycerin Cetearyl Alcohol Potassium Sorbate Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Identifiers & Packaging Pill Appearance Color: white Marketing Status OTC MONOGRAPH DRUG Active Since 2026-01-14 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 51727-6 Section 51945-4 Section 55105-1 Section 55106-9 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) Section 55106-9 (55106-9) Advanced Ingredient Data [{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVENA SATIVA (OAT) STARCH", "unii": "904CE6697V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": 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"strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYL FERULATE", "unii": "5B8915UELW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL SALICYLATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL METHOXYDIBENZOYLMETHANE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)", "unii": "74G4R6TH13", "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: 2026-02-15T12:08:16.534256 · Updated: 2026-03-14T23:12:26.991151