Label: ESIKA PERFECTBLOCK MULTIPROTECTOR SOLAR DE AMPLIO ESPECTRO PARA ROSTRO Y CUERPO FPS 50PLUS- avobenzone, homosalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-988-01 - 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 July 14, 2016
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- 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.
- Reaplicar:
- Después de 40 minutos de nadar o sudar.
- Inmediatamente después de secarse con toalla
- Al menos cada 2 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 cáncer 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 más 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, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CITRIC ACID, OXOTHIAZOLIDINE, BUTYLPHENYL METHYLPROPIONAL, HEXYL CINNAMAL, CITRONELLOL, ALPHA-ISOMETHYL IONONE, GERANIOL.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 80 ml Bottle Label
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INGREDIENTS AND APPEARANCE
ESIKA PERFECTBLOCK MULTIPROTECTOR SOLAR DE AMPLIO ESPECTRO PARA ROSTRO Y CUERPO FPS 50PLUS
avobenzone, homosalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-988 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.1 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.08 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) PHENETHYL BENZOATE (UNII: 0C143929GK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL PALMITATE (UNII: 5ZA2S6B08X) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OXOTHIAZOLIDINE (UNII: M6U1ZG59XD) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-988-01 80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/13/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/13/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-988)
