Label: BANANA BOAT ACEITE BRONCEADOR SECO TANNING DRY SPF 6- homosalate and octisalate and octocrylene and avobenzone oil
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Contains inactivated NDC Code(s)
NDC Code(s): 17630-2025-1 - Packager: Accra-Pac, Inc.
- 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 March 18, 2010
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- 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.
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INGREDIENTS:
Alcohol Denat., Homosalate, Ethylhexyl Salicylate, Paraffinum Liquidum, Diethylhexyl 2,6-Naphthalate, Octocrylene, Cocos Nucifera, Vitis Vinifera, Butyl Methoxydibenzoylmethane, Caprylyl Glycol, Acrylates/Octylacrylamide Copolymer, Dimethyl Capramide, Parfum, Aloe Barbadensis, Retinyl Palmitate, Tocopherol
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INGREDIENTES:
Alcohol desnaturalizado, homosalato, etilhexil salicilato, parafina líquida, dietilhexil 2,6-naftalato, octocrileno, Cocos nucifera, Vitis vinifera, butil metoxidibenzoilmetano, caprilil glicol, copolímero de octilacrilamida acrilatos, dimetil capramida, perfume, Aloe barbadensis, retinil palmitato, tocoferol
HECHO EN E.U.A. Fabricado y Comercializado por Energizer Personal Care Products. 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. EVEREADY DE CHILE S.A. Avda. Del Valle 869 Of.02. Edificio Vanguardia – Ciudad Empresarial, Santiago de Chile, Tel.: 597-7900. SCHICK & ENERGIZER PERÚ, S.A. Av. Baquíjano y Carrillo (Ex-Jorge Chávez) N° 336, Miraflores. Lima 18 – Perú. 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 Piso 8 Bogotá - Colombia. 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.
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INGREDIENTS AND APPEARANCE
BANANA BOAT ACEITE BRONCEADOR SECO TANNING DRY SPF 6
homosalate and octisalate and octocrylene and avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.04 mL in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.04 mL in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.025 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.01 mL in 1 mL Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALOE VERA LEAF (UNII: ZY81Z83H0X) GRAPE SEED OIL (UNII: 930MLC8XGG) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2025-1 177 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE