BANANA BOAT SPORT PERFORMANCE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [KIK CUSTOM PRODUCTS]

BANANA BOAT SPORT PERFORMANCE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [KIK CUSTOM PRODUCTS]
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NDC	61047-820-81
Set ID	9c96ce31-4ace-46a7-a3e8-f9f956d5995e
Category	HUMAN OTC DRUG LABEL
Packager	KIK Custom Products
Generic Name
Product Class
Product Number
Application Number	PART348

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ACTIVE INGREDIENT

Drug Facts:

Avobenzone:     1%
Homosalate:       10%
Octisalate:            5%
Octicrylene:        0.8%
Oxybenzone:      4%

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 IF 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 SPORT PERFORMANCE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61047-820
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.59 mL in 59 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	5.9 mL in 59 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.95 mL in 59 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.47 mL in 59 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.36 mL in 236 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61047-820-81	59 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/25/2010

Labeler - KIK Custom Products (243547333)

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