BANANA BOAT ULTRA DEFENSE BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Banana Boat Ultra Defense Broad Spectrum by

Drug Labeling and Warnings

Banana Boat Ultra Defense Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by KIK Custom Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts:

Avobenzone:     1.5%
Homosalate:       15%
Octisalate:            5%
Octicrylene:        1.25%
Oxybenzone:    6%

Purpose:  Sunscreen

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT, DO NOT GET INTO EYES IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
STOP USE AND ASK DOCTOR IS IRRITATION OR RASH DEVELOPS.  KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

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

Questions or Comments:  Call 1-800-SAFESUN Mon-Fri.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BANANA BOAT ULTRA DEFENSE BROAD SPECTRUM 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61047-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	2.36 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: 61047-811-72	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	03/23/2010

Labeler - KIK Custom Products (243547333)