{"active_ingredient":["Ingredientes activos OCTINOXATE 3% TITANIUM DIOXIDE 6.24% ZINC OXIDE 4.90%"],"do_not_use":["No usar en piel dañada o lastimada."],"dosage_and_administration":["Instrucciones Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol. Reaplicar por lo menos cada dos horas. Use un protector solar resistente al agua si usted nada o suda. Niños menores a 6 meses de edad: Consulte al médico"],"effective_time":"20260724","id":"575fb2c3-e333-8a3b-e063-6394a90a9fd9","inactive_ingredient":["Ingredientes inactivos MICA, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, MAGNESIUM STEARATE, TRIMETHYLSILOXYSILICATE, ISOSTEARYL NEOPENTANOATE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, GLYCERIN, ALUMINA, TOCOPHERYL ACETATE, FRAGRANCE, CAPRYLYL GLYCOL, CERAMIDE NP, CHLORPHENESIN, SILICA, NIACINAMIDE, LINALOOL, HYDROXYCITRONELLAL, TERPINEOL, CITRONELLOL, GERANIOL, LIMONENE, ALPHA-ISOMETHYL IONONE. Puede Contener: TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE."],"indications_and_usage":["Uso Ayuda a prevenir quemaduras solares"],"keep_out_of_reach_of_children":["Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente"],"openfda":{"application_number":["M020"],"brand_name":["ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 180-F","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 200-C","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 220-C","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 270-C","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 310-C","ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 420-C"],"generic_name":["OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE"],"is_original_packager":[true],"manufacturer_name":["BEL STAR S.A."],"package_ndc":["14141-592-01","14141-595-01","14141-594-01","14141-596-01","14141-598-01","14141-593-01","14141-597-01"],"product_ndc":["14141-592","14141-595","14141-594","14141-596","14141-598","14141-593","14141-597"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["575fb2c3-e333-8a3b-e063-6394a90a9fd9"],"spl_set_id":["575fb2c3-e332-8a3b-e063-6394a90a9fd9"],"substance_name":["OCTINOXATE","TITANIUM DIOXIDE","ZINC OXIDE"],"unii":["SOI2LOH54Z","4Y5P7MUD51","15FIX9V2JP"]},"other_safety_information":["Otra información Proteja el producto del calor excesivo y del sol directo."],"package_label_principal_display_panel":["110-C 110-C 110c","180-F 180-F 180f","200-C 200-C 200c","220-C 220-C 220c","270-C 270-C 270c","310-C 310-C 310c","420-C 420-C 420c"],"purpose":["Propósito Protector solar"],"set_id":"575fb2c3-e332-8a3b-e063-6394a90a9fd9","spl_product_data_elements":["ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA POLYMETHYLSILSESQUIOXANE (2 MICRONS) HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER DIMETHICONE MAGNESIUM STEARATE TRIMETHYLSILOXYSILICATE (M/Q 0.66) ISOSTEARYL NEOPENTANOATE HYDROGEN DIMETHICONE (13 CST) PHENOXYETHANOL GLYCERIN ALUMINA ALPHA-TOCOPHEROL ACETATE CAPRYLYL GLYCOL CERAMIDE NP CHLORPHENESIN SILICA NIACINAMIDE LINALOOL, (+)- HYDROXYCITRONELLAL TERPINEOL CITRONELLOL GERANIOL LIMONENE, (+)- ALPHA-ISOMETHYL IONONE TRIETHOXYCAPRYLYLSILANE CI 77491 CI 77492 CI 77499 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 220-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE DIMETHICONE PHENOXYETHANOL ALUMINA ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) CI 77492 TRIETHOXYCAPRYLYLSILANE ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 200-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE DIMETHICONE PHENOXYETHANOL ALUMINA ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) CI 77492 TRIETHOXYCAPRYLYLSILANE ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 270-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE DIMETHICONE PHENOXYETHANOL ALUMINA ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) CI 77492 TRIETHOXYCAPRYLYLSILANE ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 420-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE DIMETHICONE PHENOXYETHANOL ALUMINA HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN CI 77492 TRIETHOXYCAPRYLYLSILANE ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 180-F OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE PHENOXYETHANOL ALUMINA ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) DIMETHICONE TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) CI 77492 TRIETHOXYCAPRYLYLSILANE ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 310-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE MICA ISOSTEARYL NEOPENTANOATE NIACINAMIDE DIMETHICONE PHENOXYETHANOL ALUMINA ALPHA-ISOMETHYL IONONE CI 77499 CAPRYLYL GLYCOL LINALOOL, (+)- SILICA HYDROXYCITRONELLAL TERPINEOL CHLORPHENESIN HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER GLYCERIN POLYMETHYLSILSESQUIOXANE (2 MICRONS) TRIMETHYLSILOXYSILICATE (M/Q 0.66) ALPHA-TOCOPHEROL ACETATE CERAMIDE NP LIMONENE, (+)- CI 77491 MAGNESIUM STEARATE GERANIOL CITRONELLOL HYDROGEN DIMETHICONE (13 CST) CI 77492 TRIETHOXYCAPRYLYLSILANE"],"spl_unclassified_section":["Información del medicamento .Información del medicamento"],"stop_use":["Detenga su uso y consulte al doctor si sucede enrojecimiento."],"version":"1","warnings":["Advertencias Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que unicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma. Sólo para uso externo. No usar en piel dañada o lastimada. Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar. Detenga su uso y consulte al doctor si sucede enrojecimiento. Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente"],"when_using":["Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar."]}