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Name:Banana Boat Sport Performance Active Dry Protect Spf Uvb 50
Manufacturer:Kik Custom Products
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat Sport Performance Active Dry Protect Advanced UVA/UVB Sunscreen SPF 50 -Long Lasting Protection, Sun Tested, Sun Proven

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

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.

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Banana Boat Sport Performance Active Dry Protect Advanced UVA/UVB Sunscreen SPF 50 -Long Lasting Protection, Sun Tested, Sun Proven

Drug Facts:

Avobenzone:1.5%
Homosalate: 15%
Octisalate:  5%
Octocrylene: 1.25%
Oxybenzone:  5%


Purpose:  Sunscreen

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.

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

Image of Tube Label - Back

Image of Tube Label - Front

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

Sunscreen


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.


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 53.1 mL  in 354 mL
Octisalate (Octisalate) Octisalate 17.7 mL  in 354 mL
Octocrylene (Octocrylene) Octocrylene 4.42 mL  in 354 mL
Oxybenzone (Oxybenzone) Oxybenzone 17.7 mL  in 354 mL
Avobenzone (Avobenzone) Avobenzone 5.31 mL  in 354 mL
Inactive Ingredients
Ingredient Name Strength
Phenoxyethanol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61047-831-83 354 mL in 1 BOTTLE None

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)

Revised: 05/2011 KIK Custom Products



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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