NDC | 17630-2006-1 |
Set ID | bcebfcd8-e4f0-482e-abb7-4e7ca3cfa0b9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Accra-Pac, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS:
- DIRECTIONS:
- USAGE ADVICE:
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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, Caprylic/Capric Triglycerides, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Sodium Chloride, Disodium EDTA, Lactoperoxidase, Glucose Oxidase, Aloe Barbadensis, Tocopheryl Acetate, Sodium Citrate, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate.
MADE IN U.S.A.
DISTRIBUTED BY:
ENERGIZER GROUP LTD
SWORD HOUSE, HP13 6DG
HIGH WYCOMBE, UK
www.bananaboat.co.ukManufactured by:
Accra Pac, Inc (dba KIK Custom Products) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANANA BOAT BABY TEAR FREE LOTION SPF 50
homosalate and octinoxate and octisalate and octocrylene and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.1 mL in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 mL in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 mL in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.05 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 mL in 1 mL Inactive Ingredients Ingredient Name Strength BEMOTRIZINOL (UNII: PWZ1720CBH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE DISODIUM (UNII: 7FLD91C86K) GLUCOSE OXIDASE (UNII: 0T8392U5N1) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SODIUM CITRATE (UNII: 1Q73Q2JULR) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2006-1 180 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/23/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE