Label: ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 CLARO (BEIGE)- octinoxate and zinc oxide lotion
ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 MEDIO (BROWN)- octinoxate and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-996-01, 13537-996-02, 13537-997-01, 13537-997-02 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 16, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Usos
- Ayuda a prevenir quemaduras solares.
- Si se usa según las indicaciones con otras medidas de protección (ver Instrucciones), disminuye el riesgo de cancer en la piel y el envejecimiento prematuro causados por el sol.
- Advertencias
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Instrucciones
- Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
- Use un protector solar resistente al agua si usted nada o suda.
- Re- aplicar por lo menos cada dos horas.
- Niños menores a 6 meses de edad: Consulte al médico
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Medidas de protección solar. Pasar tiempo en el sol incrementa su riesgo de cancer en la piel y envejecimiento prematuro. Para disminuir este riesgo, regularmente use un protector solar con un valor de Amplio Espectro FPS de 15 o mas alto y otras medidas de protección incluyendo:
- Limitar el tiempo en el sol, especialmente de 10 a.m - 2 p.m.
- Vestir camisas de manga larga, pantalones, sombreros y gafas de sol.
- Otra información
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Ingredientes inactivos
WATER, DIMETHICONE, PEG-10 DIMETHICONE, PROPYLENE GLYCOL, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, PEG/PPG-18/18 DIMETHICONE, SILICA, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, SODIUM CHLORIDE, CAPRYLYL GLYCOL, CHLORPHENESIN, DISTEARDIMONIUM HECTORITE, PHENETHYL ALCOHOL, PPG-2 METHYL ETHER, SODIUM HYALURONATE, METHYLISOTHIAZOLINONE.
MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO (BEIGE)
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO (BROWN)
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INGREDIENTS AND APPEARANCE
ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 CLARO (BEIGE)
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-996 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.084 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N) HYALURONATE SODIUM (UNII: YSE9PPT4TH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-996-02 1 in 1 BOX 08/23/2016 1 NDC:13537-996-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/23/2016 ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 MEDIO (BROWN)
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-997 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.084 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N) HYALURONATE SODIUM (UNII: YSE9PPT4TH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-997-02 1 in 1 BOX 08/23/2016 1 NDC:13537-997-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/23/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-996, 13537-997)
