Home SPL Set DailyMed SPL v2 SPL SPL Set ID f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 Route TOPICAL Published Effective Date 2023-02-24 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Phenoxyethanol (1.8 g) Fragrance 13576 (0.8 g) Ethylhexylglycerin (0.4 g) Avobenzone (0.2 g) .beta.-sitosterol (2 g) Hydrolysed Marine Collagen (enzymatic; 2000 Mw) (0.01 g) Linoleic Acid (0.16 g) Tocopherol (0.08 g) Malva Sylvestris Flowering Top (0.06 g) Papaver Rhoeas Flower (0.04 g) Medium-chain Triglycerides (34 g) Shea Butter (4 g) Linolenic Acid (3 g) Polyglyceryl-4 Isostearate (2.7 g) Hexyl Laurate (1 g) White Wax (125.88 g) Hydrogenated Castor Oil (7 g) Amiloxate (1.6 g) Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) (0.00004 g) Squalane Water Glycerin Cetearyl Ethylhexanoate Inactive Ingredients Edetate Disodium Anhydrous Magnesium Sulfate, Unspecified Potassium Sorbate Sodium Benzoate Citric Acid Monohydrate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2023-02-23 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": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "ACTIB", "strengthNumerator": "0.8", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "0.4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": ".BETA.-SITOSTEROL", "unii": "S347WMO6M4", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 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