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Banana Boat Ultra Mist Kids FPS 60 LATAM

Dosage form: spray
Ingredients: HOMOSALATE 0.10mL in 1mL, OCTINOXATE 0.075mL in 1mL, OCTISALATE 0.05mL in 1mL, OCTOCRYLENE 0.05mL in 1mL, AVOBENZONE 0.03mL in 1mL
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2045

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.

Banana Boat Ultra Mist Kids FPS 60 LATAM

Drug Facts

Active Ingredients

Homosalate 0.10mL / 1mL

Octinoxate 0.075mL / 1mL

Octisalate 0.05mL / 1mL

Octocrylene 0.05mL / 1mL

Avobenzone 0.03mL / 1mL

INSTRUCCIONES:

Aplíque generosamente o libremente media hora antes de la exposición al sol y como sea necesario. Para mantener la protección, repita cada dos horas al transpirar, bañarse, o secarse. Es necesario reiterar la aplicación para mantener la efectividad del producto.

PRECAUCIONES:

Para uso externo. Puede causar irritación a los ojos. Suspenda su empleo si se presentan signos de irritación o salpullido. No exponer lactantes y niños menores a radiación solar. Para niños menores de seis (6) meses consulte al médico. La exposición excesiva al sol es un peligro importante para la salud. Inflamable. No pulverizar cerca de llama. No perforar ni incinerar. No exponer al sol ni a temperaturas superiores a 50° C. Proteger los ojos durante la aplicación. Mantener fuera del alcance de los niños.

INGREDIENTS:

Aqua, Isohexadecane, Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Octocrylene, Cetyl PEG/PPG-10/1 Dimethicone, Butyl Methoxydibenzoylmethane, Bis-ethylhexyloxyphenol Methoxyphenyl Triazine, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylyl Glycol, Glucose, Sodium Chloride, Glycerin, Sodium Citrate, Disodium EDTA, Caprylic/Capric Triglycerides, Stearlkonium Hectorite, Propylene Carbonate, Lactoperoxidase, Glucose Oxidase, Aloe Barbadensis, Tocopheryl Acetate, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate

INGREDIENTES:

Agua, isohexadecano, homosalato, metoxicinamato de etilo, salicilato de etilo, octocrileno, cetil PEG/PPG-10/1 dimeticona, butil metoxidibenzoilmetano, bis-etilhexiloxifenol metoxifenil triazina, PEG-8, copolímero de MA/olefin C30-38/maleato de isopropilo, caprilil glicol, glucosa, cloruro de sodio, glicerina, citrato de sodio, ácido etilendiaminotetraacético disódico (EDTA), triglicerido caprilico / cáprico, hectorita de estearalconio, carbonato de propileno, lactoperoxidasa, glucose oxidasa, Aloe barbadensis, acetato de tocoferilo, palmitato de retinilo, tocoferol, ascorbil fosfato de sodio

HECHO EN E.U.A.

Importado y distribuido por: EVEREADY DE MÉXICO, S.A. de C.V. Jaime Balmes No. 11, Torre A, Piso 3, Col. Los Morales Polanco, C.P. 11510 México, D.F., R.F.C. EME-861014-J90. Tels. Atención al Consumidor: De Provincia al 01 800 7039900. En el D.F. al 91382057. SCHICK & ENERGIZER PERÚ, S.A. Av. Baquíjano y Carrillo (Ex-Jorge Chávez) N° 336, Miraflores. Lima 18 – Perú. Telif. 2429600. RUC: 20506285586. EVEREADY ECUADOR, C.A. Avda. Interoceánica Km. 4-1/2 (Vía Cumbaya-Miravalle) P.O. Box 17-17-1764, Quito-Ecuador, Telf. (593-2) 2899450. EVEREADY DE COLOMBIA, S.A. Transv. 18 No. 96 – 41 P i s o 8 B o g o t á - C o l omb i a . ENERGIZER ARGENTINA, S.A. Tucumán 540, Piso 22 "A" C.A.B.A. L e g a j o N o . 2 7 0 5 P r o d u c t o Cosmé t i co. Aprobado s e gún Resolución 155/98 Tel. At. al Cons. (011) 4742 - 8193.

Manufactured by: Accra Pac, Inc (dba KIK Custom Products)

PRINCIPAL DISPLAY PANEL

Ultra
MistTM
BANANA
BOATTM
Kids
Sin Lágrimas
Protector Solar con Fotoprotección
Avanzada UVA y UVB
FPS 60
AvoTriplexTM
Alta protección UVA
Probado en el sol
y laboratorio
Aplicación Rápida y Uniforme
Hipoalergénico
Resitente al agua
Sin Fragancia
Contenido neto 175 ml

BANANA BOAT ULTRA MIST KIDS FPS 60 LATAM
homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17630-2045
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (HOMOSALATE)	HOMOSALATE	0.10 mL in 1 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.075 mL in 1 mL
OCTISALATE (OCTISALATE)	OCTISALATE	0.05 mL in 1 mL
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	0.05 mL in 1 mL
AVOBENZONE (AVOBENZONE)	AVOBENZONE	0.03 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BEMOTRIZINOL
CAPRYLYL GLYCOL
SODIUM CHLORIDE
GLYCERIN
SODIUM CITRATE
EDETATE DISODIUM
MEDIUM-CHAIN TRIGLYCERIDES
PROPYLENE CARBONATE
GLUCOSE OXIDASE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE, D-
VITAMIN A PALMITATE
SODIUM ASCORBYL PHOSPHATE
POLYETHYLENE GLYCOL 400

Packaging
#	Item Code	Package Description
1	NDC:17630-2045-1	175 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	03/09/2010

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Operations
Accra-Pac, Inc.		024213616	MANUFACTURE

Revised: 04/2010

Document Id: 289b4459-15ba-45f6-b571-51559b4b2d2e

Set id: 3aa6550e-d1ed-4064-bf58-e694705669a8

Version: 2

Effective Time: 20100424

Accra-Pac, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Banana Boat Ultra Mist Kids FPS 60 LATAM

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