Home SPL Set DailyMed f564bbf0-3b5c-4a81-e053-2a95a90a7ea6 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 Active Ingredient Indications and Usage Dosage and Administration Section 50565-1 Section 50570-1 Section 51727-6 Section 51945-4 Section 55105-1 Structured Label Content Warnings and Precautions (34071-1) Active Ingredient (55106-9) Indications and Usage (34067-9) Dosage and Administration (34068-7) 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) 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; 2000 MW)", "unii": "2WID9OCG7P", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINOLEIC ACID", "unii": "9KJL21T0QJ", "classCode": "ACTIB", "strengthNumerator": "0.16", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "ACTIB", "strengthNumerator": "0.08", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MALVA SYLVESTRIS FLOWERING TOP", "unii": "X1U1U0N90J", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PAPAVER RHOEAS FLOWER", "unii": "Y1MLS7E68X", "classCode": "ACTIB", "strengthNumerator": "0.04", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "ACTIB", "strengthNumerator": "34", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "LINOLENIC ACID", "unii": "0RBV727H71", "classCode": "ACTIB", "strengthNumerator": "0.04", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYGLYCERYL-4 ISOSTEARATE", "unii": "820DPX33S7", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HEXYL LAURATE", "unii": "4CG9F9W01Q", "classCode": "ACTIB", "strengthNumerator": "2.7", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGENATED CASTOR OIL", "unii": "ZF94AP8MEY", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AMILOXATE", "unii": "376KTP06K8", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)", "unii": "8INO2K35FA", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SQUALANE", "unii": "GW89575KF9", "classCode": "ACTIB", "strengthNumerator": "0.01", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "ACTIB", "strengthNumerator": "125.88", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "1.6", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.00004", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CETEARYL ETHYLHEXANOATE", "unii": "9M64UO4C25", "classCode": "ACTIB", "strengthNumerator": "4", "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: 2026-02-15T12:01:13.257421 · Updated: 2026-03-14T23:01:17.657881