Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb68c3ab-7835-1a1c-e053-2995a90a0d66 Route TOPICAL Published Effective Date 2022-10-19 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Glycerin (0.08784 g) Geraniol (0.003398 g) Isopropyl Alcohol (0.002132 g) Alcohol (0.002 g) Oxybenzone (3.5436 mL) Phenoxyethanol (1.6 g) Tea Tree Oil (1.3 g) Imidurea (0.585 g) Water (0.1 g) Glyceryl Stearate Se (0.4 g) Carbomer Homopolymer, Unspecified Type (155.839258 mL) Tioxolone (6 g) Linalool, (+/-)- (0.8 g) Fd&c Yellow No. 5 (0.3 g) Benzyl Benzoate (0.026404 g) Panthenol (0.01044 g) Coumarin (0.004 g) C12-20 Acid Peg-8 Ester (0.04 g) Arctium Lappa Root (0.000892 g) Propylparaben (0.003924 g) Cetyl Alcohol (0.00156 g) Yeast, Unspecified (0.03 g) Riboflavin (4 g) Propylene Glycol (0.012 g) Cetearyl Ethylhexanoate (0.003512 g) Hydroxyethyl Cellulose, Unspecified (0.28 g) Butylated Hydroxytoluene (0.015 g) Citral (0.2 g) Green Tea Leaf (0.00012 g) Allantoin (6.469044 g) Limonene, (+)- (0.8 mL) Niacinamide (10 g) Powdered Cellulose (0.12863 g) Polyoxyl 40 Hydrogenated Castor Oil (0.104 g) .alpha.-hexylcinnamaldehyde (0.01032 g) Octinoxate (0.00679 g) Methylparaben (0.061818 g) Fragrance 13576 (0.02 g) Inactive Ingredients Pyridoxine Hydrochloride Cetyl Phosphate Sodium Benzoate Sodium Chloride Citric Acid Monohydrate Thiamine Hydrochloride Edetate Disodium Anhydrous Trolamine Potassium Sorbate Sodium Acetate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-19 Until 2027-02-20 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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.08784", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GERANIOL", "unii": "L837108USY", "classCode": "ACTIB", "strengthNumerator": "0.003398", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "0.002132", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PYRIDOXINE HYDROCHLORIDE", "unii": "68Y4CF58BV", "classCode": "IACT", "strengthNumerator": "0.002", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "3.5436", "strengthDenominator": "200", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "1.6", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL PHOSPHATE", "unii": "VT07D6X67O", "classCode": "IACT", "strengthNumerator": "0.585", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "155.839258", "strengthDenominator": "200", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "ACTIB", "strengthNumerator": "0.8", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TIOXOLONE", "unii": "S0FAJ1R9CD", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "ACTIB", "strengthNumerator": "0.026404", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "ACTIB", "strengthNumerator": "0.01044", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZYL BENZOATE", "unii": "N863NB338G", "classCode": "ACTIB", "strengthNumerator": "0.004", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "ACTIB", "strengthNumerator": "0.04", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.000892", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "COUMARIN", "unii": "A4VZ22K1WT", "classCode": "ACTIB", "strengthNumerator": "0.003924", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "0.00156", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.03", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C12-20 ACID PEG-8 ESTER", "unii": "9M7A3K4339", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "THIAMINE HYDROCHLORIDE", "unii": "M572600E5P", "classCode": "IACT", "strengthNumerator": "0.012", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ARCTIUM LAPPA ROOT", "unii": "597E9BI3Z3", "classCode": "ACTIB", "strengthNumerator": "0.003512", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "ACTIB", "strengthNumerator": "0.28", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "ACTIB", "strengthNumerator": "0.015", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "YEAST, UNSPECIFIED", "unii": "3NY3SM6B8U", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "RIBOFLAVIN", "unii": "TLM2976OFR", "classCode": "ACTIB", "strengthNumerator": "0.00012", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "6.469044", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.8", "strengthDenominator": "200", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CETEARYL ETHYLHEXANOATE", "unii": "9M64UO4C25", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "ACTIB", "strengthNumerator": "0.12863", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "ACTIB", "strengthNumerator": "0.104", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRAL", "unii": "T7EU0O9VPP", "classCode": "ACTIB", "strengthNumerator": "0.01032", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "ACTIB", "strengthNumerator": "0.00679", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.061818", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.02", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "ACTIB", "strengthNumerator": "0.001066", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.000892", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-HEXYLCINNAMALDEHYDE", "unii": "7X6O37OK2I", "classCode": "ACTIB", "strengthNumerator": "0.00574", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "0.00462", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.996", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "200", "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: 2026-02-15T12:01:13.298957 · Updated: 2026-03-14T23:01:17.657881