Home SPL Set DailyMed SPL v2 SPL SPL Set ID ebe024f7-7c45-ad60-e053-2995a90a45d6 Route TOPICAL Published Effective Date 2022-10-25 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Avobenzone (2 g) Phenoxyethanol (1.62 g) Fragrance 13576 (0.98 g) Dehydroacetic Acid (0.14 g) Hydrolyzed Bovine Elastin (base; 1000 Mw) (0.03 g) Octinoxate (0.008 g) Coco-glycerides (5 g) Glycerin (8 g) Hydrolysed Marine Collagen (enzymatic; 2000 Mw) (6.94 g) Cetostearyl Alcohol (0.6 g) Medium-chain Triglycerides (12.58 g) Cetyl Alcohol (12 g) .alpha.-hexylcinnamaldehyde (4 g) Water (0.006 g) Benzoic Acid (0.024 g) Centaurea Cyanus Flower (0.16 g) Viola Odorata (140 mL) Limonene, (+)- (1.4 g) Potassium Phosphate, Unspecified Form (0.24 g) .beta.-citronellol, (r)- (0.1 g) Isomethyl-.alpha.-ionone (0.05 g) Butylated Hydroxytoluene (0.038 g) Inactive Ingredients Citric Acid Monohydrate Sodium Benzoate Potassium Sorbate Sodium Cetostearyl Sulfate Edetate Disodium Anhydrous Sodium Hydroxide Sodium Phosphate, Dibasic, Anhydrous Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-25 Until 2026-10-20 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": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "1.62", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.98", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DEHYDROACETIC ACID", "unii": "2KAG279R6R", "classCode": "ACTIB", "strengthNumerator": "0.14", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW)", "unii": "ZR28QKN0WT", "classCode": "ACTIB", "strengthNumerator": "0.03", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.008", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "COCO-GLYCERIDES", "unii": "ISE9I7DNUG", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "6.94", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)", "unii": "2WID9OCG7P", "classCode": "ACTIB", "strengthNumerator": "0.6", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "ACTIB", "strengthNumerator": "12.58", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.006", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.024", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-HEXYLCINNAMALDEHYDE", "unii": "7X6O37OK2I", "classCode": "ACTIB", "strengthNumerator": "0.16", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "140", "strengthDenominator": "200", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CETOSTEARYL SULFATE", "unii": "7ZBS06BH4B", "classCode": "IACT", "strengthNumerator": "1.4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "ACTIB", "strengthNumerator": "0.24", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CENTAUREA CYANUS FLOWER", "unii": "QZ239038YC", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "VIOLA ODORATA", "unii": "AET12U8B74", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "ACTIB", "strengthNumerator": "0.038", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM PHOSPHATE, UNSPECIFIED FORM", "unii": "B7862WZ632", "classCode": "ACTIB", "strengthNumerator": "0.006", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".BETA.-CITRONELLOL, (R)-", "unii": "P01OUT964K", "classCode": "ACTIB", "strengthNumerator": "0.0056", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ISOMETHYL-.ALPHA.-IONONE", "unii": "9XP4LC555B", "classCode": "ACTIB", "strengthNumerator": "0.0054", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "ACTIB", "strengthNumerator": "0.005", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "0.012", "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: 2026-02-15T12:01:13.303084 · Updated: 2026-03-14T23:01:19.203951