Home SPL Set DailyMed SPL v2 SPL SPL Set ID e99d92c4-8768-9c0a-e053-2a95a90a609e Route TOPICAL Published Effective Date 2022-10-15 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Carbomer Homopolymer, Unspecified Type (0.025 g) Glycerin (0.005 g) Linolenic Acid (0.00275 g) Tromethamine (0.22 g) Octocrylene (1.8 g) Butylated Hydroxytoluene (0.0018 g) Propylene Glycol (2.5 g) Water (27.55 mL) Fragrance 13576 (0.3 g) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) (0.15 g) .alpha.-tocopherol (0.075 g) Poly(methyl Methacrylate; 450000 Mw) (0.006 g) Avobenzone (2.1 g) Titanium Dioxide (0.425 g) Phenoxyethanol (0.35 g) Polyethylene Glycol 400 (0.14225 g) Linoleic Acid (0.49725 g) Silicon Dioxide (0.575 g) Anhydrous Citric Acid (0.4125 g) Ascorbyl Palmitate (0.00025 g) Ascorbic Acid (0.00125 g) Octisalate (1.45 g) Bemotrizinol (1.25 g) Dimethicone (3.5982 g) Octinoxate (0.3375 g) Butylene Glycol (0.1 g) C20-22 Alcohols Chlorphenesin Inactive Ingredients Potassium Cetyl Phosphate Edetate Disodium Anhydrous C20-22 Alkyl Phosphate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-15 Until 2027-04-29 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": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.005", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINOLENIC ACID", "unii": "0RBV727H71", "classCode": "ACTIB", "strengthNumerator": "0.00275", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TROMETHAMINE", "unii": "023C2WHX2V", "classCode": "ACTIB", "strengthNumerator": "0.22", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "ACTIB", "strengthNumerator": "0.0018", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "27.55", "strengthDenominator": "50", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.3", "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 COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "71DD5V995L", "classCode": "ACTIB", "strengthNumerator": "0.075", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.025", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIB", "strengthNumerator": "0.006", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLY(METHYL METHACRYLATE; 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