BANANA BOAT SPORT PERFORMANCE ACTIVE DRY PROTECT SPF UVB 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Banana Boat Sport Performance Active Dry Protect SPF UVB 50 by

Drug Labeling and Warnings

Banana Boat Sport Performance Active Dry Protect SPF UVB 50 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%
Octocrylene: 1.25%
Oxybenzone:  5%

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, Stearyl Alcohol, Glycerin, Capryly Glycol, Hydrogenated Dimer, Dilnoleyl Dimethyl Carbonate, Copolymer,
Cetyl Alcohol, Triethanolamine, Behenyl Alcohol, Glyceryl Stearate, Glceryl Stearate Citrate, Disodium, Ethylene,
Dicocamide PEG/15 Disulfate, Sodium Lauryl Sarcosinate, Carbomer, Xanthan Gum, Aloe Barbadenis Leaf Juice, Retinyl Palmitate,
Tocophenol, Tocopheryl Acetate, Cetearyl Alcohol, Sodium Lauryl Lactylate, Leithin, BHT, Methyl Dibromo, Glutaronitrile, Methylchloroisothiazolinone,
Methylisothiazolinone, Phenoxyl Ethanol, Dipropylene Glycol, Disodium EDTA.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

PURPOSE

Sunscreen

INDICATIONS & USAGE

Directions:

Apply generously and evenly to all areas 15 minutes before sun exposure.

Re-Apply at frequent intervals and after swimming and towel drying.

Ask a doctor for use on children under 6 months of age.

INGREDIENTS AND APPEARANCE

BANANA BOAT SPORT PERFORMANCE ACTIVE DRY PROTECT SPF UVB 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61047-831
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	53.1 mL  in 354 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	17.7 mL  in 354 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	4.42 mL  in 354 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	17.7 mL  in 354 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	5.31 mL  in 354 mL

Inactive Ingredients
Ingredient Name	Strength
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61047-831-83	354 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2011

Labeler - KIK Custom Products (243547333)