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Banana Boat Ultra Defense Sheer Protect

Dosage form: lotion
Ingredients: Avobenzone 2.36mL in 236mL, Homosalate 23.6mL in 236mL, Octisalate 11.8mL in 236mL, Octocrylene 1.88mL in 236mL, Oxybenzone 9.44mL in 236mL
Labeler: KIK Custom Products
NDC Code: 61047-812

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.

Banana Boat Ultra Defense Sheer Protect Advanced UVA/UVB Sunscreen SPF UVB30 Aloe Vera -Long Lasting Protection, Sun Tested, Sun Proven

Drug Facts:

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

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

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

BANANA BOAT ULTRA DEFENSE SHEER PROTECT 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61047-812
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone2.36 mL  in 236 mL
Homosalate (Homosalate) Homosalate23.6 mL  in 236 mL
Octisalate (Octisalate) Octisalate11.8 mL  in 236 mL
Octocrylene (Octocrylene) Octocrylene1.88 mL  in 236 mL
Oxybenzone (Oxybenzone) Oxybenzone9.44 mL  in 236 mL
Packaging
#Item CodePackage Description
1NDC:61047-812-73236 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/19/2010
Labeler - KIK Custom Products (243547333)

Revised: 03/2010
 
KIK Custom Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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