Home SPL Set DailyMed SPL v2 SPL SPL Set ID eac771e2-4c1b-3808-e053-2995a90ac5fc Route TOPICAL Published Effective Date 2022-10-17 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Allantoin (0.05 g) Aloe Vera Leaf (2.5 g) Fragrance 13576 (0.225 g) Glyceryl Monostearate (0.875 g) Trolamine (0.3 g) Butylated Hydroxytoluene (0.0535 g) Propylene Glycol (0.1463 g) Cetyl Alcohol (1.996 g) Tropolone (0.0038 g) Tocopherol (0.004 g) Dimethicone (0.0004 g) 1,2-hexanediol (0.25 g) Imidurea (0.198 g) Carbomer Homopolymer, Unspecified Type (0.15 g) Cetearyl Ethylhexanoate (1.75 g) Medium-chain Triglycerides (1.5 g) Caprylyl Glycol (3.4965 g) Octinoxate (0.4975 g) Glycerin (0.1 g) Glyceryl Stearate Se (27.4065 mL) Water (2.25 g) C12-20 Acid Peg-8 Ester (2 g) Oxybenzone (1.9996 g) Decyl Oleate Inactive Ingredients Cetyl Phosphate Sodium Chondroitin Sulfate (porcine; 5500 Mw) Hyaluronate Sodium .alpha.-tocopherol Acetate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-17 Until 2028-01-16 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": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.225", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "ACTIB", "strengthNumerator": "0.875", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "ACTIB", "strengthNumerator": "0.0535", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL PHOSPHATE", "unii": "VT07D6X67O", "classCode": "IACT", "strengthNumerator": "0.1463", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)", "unii": "H5BJH23Z9A", "classCode": "IACT", "strengthNumerator": "0.05", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "1.996", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "ACTIB", "strengthNumerator": "0.0038", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TROPOLONE", "unii": "7L6DL16P1T", "classCode": "ACTIB", "strengthNumerator": "0.004", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "ACTIB", "strengthNumerator": "0.0004", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "ACTIB", "strengthNumerator": "0.198", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETEARYL ETHYLHEXANOATE", "unii": "9M64UO4C25", "classCode": "ACTIB", "strengthNumerator": "1.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "ACTIB", "strengthNumerator": "0.198", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.4965", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.4975", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "27.4065", "strengthDenominator": "50", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "C12-20 ACID PEG-8 ESTER", "unii": "9M7A3K4339", "classCode": "ACTIB", "strengthNumerator": "2.25", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DECYL OLEATE", "unii": "ZGR06DO97T", "classCode": "ACTIB", "strengthNumerator": "1.9996", "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: 2026-02-15T12:01:13.314412 · Updated: 2026-03-14T23:01:19.203951