Home SPL Set DailyMed SPL v2 SPL SPL Set ID ec83846f-11c0-8f59-e053-2995a90ab9d2 Route TOPICAL Published Effective Date 2022-11-02 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Octinoxate (3.5982 g) Titanium Dioxide (0.425 g) Chlorphenesin (0.1 g) Octisalate (1.8 g) Butylene Glycol (2.5 g) Propylene Glycol (2.1 g) Poly(methyl Methacrylate; 450000 Mw) (0.00025 g) Water (27.55 mL) Silicon Dioxide (0.575 g) Butylated Hydroxytoluene (0.4125 g) Dimethicone (0.025 g) Carbomer Homopolymer, Unspecified Type (0.0018 g) C20-22 Alcohols (1.25 g) Fragrance 13576 (0.15 g) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) (0.3375 g) Tromethamine (0.3 g) Bemotrizinol (0.075 g) Polyethylene Glycol 400 (0.22 g) Ascorbyl Palmitate (1.45 g) Phenoxyethanol (0.14225 g) Octocrylene (0.00125 g) Avobenzone (0.35 g) Linolenic Acid (0.00275 g) Ascorbic Acid (0.006 g) Tocopherol (0.49725 g) Linoleic Acid (0.005 g) Glycerin Inactive Ingredients Citric Acid Monohydrate C20-22 Alkyl Phosphate Edetate Disodium Anhydrous Potassium Cetyl Phosphate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-11-02 Until 2028-03-09 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 50570-1 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 50570-1 (50570-1) Section 51727-6 (51727-6) Section 51945-4 (51945-4) Section 55105-1 (55105-1) Section 55106-9 (55106-9) Advanced Ingredient Data [{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.5982", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "0.425", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLY(METHYL METHACRYLATE; 450000 MW)", "unii": "Z47NNT4J11", "classCode": "ACTIB", "strengthNumerator": "2.1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.00025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "27.55", "strengthDenominator": "50", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "0.575", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C20-22 ALKYL PHOSPHATE", "unii": "L4VKP0Y7RP", "classCode": "IACT", "strengthNumerator": "0.4125", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "ACTIB", "strengthNumerator": "0.0018", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "1.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM CETYL PHOSPHATE", "unii": "03KCY6P7UT", "classCode": "IACT", "strengthNumerator": "0.15", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C20-22 ALCOHOLS", "unii": "O4M0347C6A", "classCode": "ACTIB", "strengthNumerator": "0.3375", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "ACTIB", "strengthNumerator": "0.075", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TROMETHAMINE", "unii": "023C2WHX2V", "classCode": "ACTIB", "strengthNumerator": "0.22", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BEMOTRIZINOL", "unii": "PWZ1720CBH", "classCode": "ACTIB", "strengthNumerator": "1.45", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "0.14225", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBYL PALMITATE", "unii": "QN83US2B0N", "classCode": "ACTIB", "strengthNumerator": "0.00125", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "0.35", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINOLENIC ACID", "unii": "0RBV727H71", "classCode": "ACTIB", "strengthNumerator": "0.00275", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "0.00025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "ACTIB", "strengthNumerator": "0.006", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINOLEIC ACID", "unii": "9KJL21T0QJ", "classCode": "ACTIB", "strengthNumerator": "0.49725", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.005", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:01:13.303763 · Updated: 2026-03-14T23:01:19.203951