Label: BANANA BOAT ULTRA DEFENSE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61047-819-80 - Packager: KIK Custom Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 25, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS
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INACTIVE INGREDIENT
Water, Cetearyl Alcohol, Glycerin, Capryly Glycol, Hydrogenated Dimer Dilnoleyl/Dimethyl Carbonate,
Copolymer, Cetyl Alcohol, Triethanolamine, Behenyl Acohol, Glyceryl Stearate, Glyceryl Stearate, Citrate,
Disodium Ethylene, Dicocamide PEG-15 Disulfate, Sodium Lauroyl Sarcosinate, Carbomer, Xanthan Gum,
Aloe Barbadensis Leaf Juice, Retinyl Palmitate (Vitamin A), Tocopherol, Tocopheryl Acetate (Vitamin E),
Cetearyl Alchol, Sodium Lauroyl, Lactylate, Lecithin, BHT, Methyl Dibromo Glutaronitrile, Methyl Chloisothiazolinone.
Methyl Isothiazolinone, Phenoxy Ethanol, Dipropylene Glycol, Disodium EDTA - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BANANA BOAT ULTRA DEFENSE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61047-819 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3.54 mL in 236 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 35.4 mL in 236 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 11.8 mL in 236 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.95 mL in 236 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 14.16 mL in 236 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61047-819-80 236 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/25/2010 Labeler - KIK Custom Products (243547333)