Home SPL Set DailyMed Drug Facts Drug Facts SPL v1 SPL SPL Set ID 5d48d24d-c12c-4809-bc61-0a451dd3401b Route TOPICAL Published Effective Date 2009-12-01 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Octinoxate (7.3 mL) Avobenzone (2.9 mL) Inactive Ingredients Castor Oil Synthetic Wax (1200 Mw) Tridecyl Trimellitate Diisostearyl Malate Hydrogenated Polybutene (1300 Mw) High Density Polyethylene Mica Almond Oil Sunflower Oil Shea Butter Titanium Dioxide Medium-chain Triglycerides C20-40 Acid Mangifera Indica Seed Butter Tocopherol Pentaerythrityl Tetraisostearate Propylene Carbonate Trihydroxypalmitamidohydroxypropyl Myristyl Ether Ferric Oxide Red Polyhydroxystearic Acid (2300 Mw) Aluminum Oxide Silicon Dioxide Silica Dimethyl Silylate Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Butylated Hydroxytoluene Butylene Glycol Pentylene Glycol Citric Acid Monohydrate Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2007-05-01 Description OCTINOXATE (7.3%), AVOBENZONE (2.9%) Medication Information Description OCTINOXATE (7.3%), AVOBENZONE (2.9%) Section 51945-4 ACTIVE INGREDIENTS : OCTINOXATE (7.3%), AVOBENZONE (2.9%) WARNINGS : Provides moderate protection against sunburn. Stop and ask a doctor if rash or irritation develops and lasts. Section 55105-1 Provides moderate protection against sunburn. Section 55106-9 OCTINOXATE (7.3%), AVOBENZONE (2.9%) Structured Label Content Section 51945-4 (51945-4) ACTIVE INGREDIENTS : OCTINOXATE (7.3%), AVOBENZONE (2.9%) WARNINGS : Provides moderate protection against sunburn. Stop and ask a doctor if rash or irritation develops and lasts. Section 55105-1 (55105-1) Provides moderate protection against sunburn. Section 55106-9 (55106-9) OCTINOXATE (7.3%), AVOBENZONE (2.9%) Advanced Ingredient Data [{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "2.9", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SYNTHETIC WAX (1200 MW)", "unii": "Q3Z4BCH099", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIDECYL TRIMELLITATE", "unii": "FY36J270ES", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIISOSTEARYL MALATE", "unii": "QBS8A3XZGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED POLYBUTENE (1300 MW)", "unii": "7D1YQ9Y5EZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH DENSITY POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALMOND OIL", "unii": "66YXD4DKO9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C20-40 ACID", "unii": "CKJ5537111", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANGIFERA INDICA SEED BUTTER", "unii": "4OXD9M35X2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PENTAERYTHRITYL TETRAISOSTEARATE", "unii": "9D7IK5483F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE CARBONATE", "unii": "8D08K3S51E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER", "unii": "NQ0RNU9701", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA DIMETHYL SILYLATE", "unii": "EU2PSP0G0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)", "unii": "J2S07SB0YL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PENTYLENE GLYCOL", "unii": "50C1307PZG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"51945-4": "ACTIVE INGREDIENTS : OCTINOXATE (7.3%), AVOBENZONE (2.9%) WARNINGS : Provides moderate protection against sunburn. Stop and ask a doctor if rash or irritation develops and lasts.", "55105-1": "Provides moderate protection against sunburn.", "55106-9": "OCTINOXATE (7.3%), AVOBENZONE (2.9%)"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:55:23.780206 · Updated: 2026-03-14T22:52:57.217022
