NDC | 17630-2023-1 |
Set ID | dac912da-1543-420e-b137-16f31557e435 |
Category | HUMAN OTC DRUG LABEL |
Packager | Accra-Pac, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- INSTRUCCIONES:
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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. Contiene oxibenzona.
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INGREDIENTS:
Aqua, Octocrylene, Benzophenone-3 (oxibenzona), Butyl Methoxydibenzoylmethane, Ethylhexyl Benzoate, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Butyloctyl Salicylate, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica, Aloe barbadensi, Polymethyl Methacrylate, Phenethyl Benzoate, Polymethylsilsesquioxane, Diisopropyl Adipate, VP/Eicosene Copolymer, Coco-Glucoside, Caprylyl Glycol, Glycerin, Dimethicone, Paraffin, Acrylates/ C12-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Xanthan Gum, Triethanolamine, Phenoxyethanol, Propylparaben, Methylparaben, Parfum
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INGREDIENTES:
Agua, Octocrileno, Benzofenona-3 (oxibenzona), Butil metoxidibenzoilmetano, Etilhexil benzoate, Alcohol cetearílico, Dicetil fosfato, Cetet-10 fosfato, Salicilato de butiloctil, Palmitato de retinilo, Ácido ascórbico, Acetato de tocoferilo, PEG-8 dimeticona, Propoxihidroxipropil tiosulfato sódico de sílice, Octildodecanol, Sílice, Aloe barbadensis, Polimetil met acrilato, Benzoato de fenil etilo, Polimetilsilsesquioxano, Diisopropil adipato, Copolímero VP/eicosene, Coco-glucósido, Caprilil glycol, Glicerina, Dimeticona, Parafina, Crospolímero de acrilatos/C12-30 alquil acrilato, Ácido etilendiaminotetraacético disódico (EDTA), Goma xantana, Trietanolamina, Fenoxietanol, Propilparabeno, Metilparabeno, Perfume
Distributed by:
ENERGIZER ARGENTINA,
S.A.Tucumán 540, Piso 22 "A"
C.A.B.A. Legajo No. 2705 Producto
Cosmético. Aprobado según
Resolución 155/98 Tel. At. al Cons.
(011) 4742 - 8193. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANANA BOAT ULTRA DEFENSE SPF 30 FOR LATAM
homosalate and octinoxate and octisalate and octocrylene and oxybenzone and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.0878 mL in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.05 mL in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 mL in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.025 mL in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.05 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 mL in 1 mL Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) PARAFFIN (UNII: I9O0E3H2ZE) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) TROLAMINE (UNII: 9O3K93S3TK) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2023-1 177 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/09/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE