Banana Boat Kids Tear Free Continuous SPF 50

Dosage form: spray
Ingredients: AVOBENZONE 0.03g in 1g, HOMOSALATE 0.15g in 1g, OCTINOXATE 0.075g in 1g, OCTISALATE 0.05g in 1g, OCTOCRYLENE 0.024g in 1g
Labeler: Accra-Pac, Inc.
NDC Code: 17630-2004

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 Kids Tear Free Continuous Spray SPF 50

Drug Facts

Active Ingredients

Avobenzone 0.03g / 1g

Homosalate 0.15g / 1g

Octinoxate 0.075g / 1g

Octisalate 0.05g / 1g

Octocrylene 0.024g / 1g

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings
  • For external use only
  • Do not spray directly into face
  • Flammable do not use near heat, flame, or while smoking

When using this product
  • avoid spraying in eyes. If contact occurs, rinse thoroughly with water.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

irritation or rash develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply generously and evenly to all areas 15 minutes before sun exposure
  • spray on hands to apply to face
  • use in well-ventilated area
  • reapply at frequent intervals and after swimming or towel drying
  • ask a doctor before use on children under six months of age

Other Information

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

  • May stain some fabrics.

Inactive Ingredients

Isobutane, Water, Isohexadecane, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Glycol, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Propylene Carbonate, Glycerin, Tocopheryl Acetate (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Sodium Citrate, Sodium Chloride, Aloe Barbadensis (Aloe Vera) Leaf Juice, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Disodium EDTA

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

www.bananaboat.com

Dist. by: SUN PHARMACEUTICALS CORP.
P.O. BOX 7869, DELRAY BEACH, FL 33482

PRINCIPAL DISPLAY PANEL

LOTION
UltraMist®
Banana Boat®
Kids
Tear Free
®
Continuous Spray Sunscreen
SPF/UVB 50 Pediatrician Tested

AvoTriplexTM
UVA Protection
3-Way
ProtectionTM
Sun-Tested, Sun-Proven
No Tearing – Alcohol Free

Very Water Resistant

NET WT. 6 OZ. (170 g)

BANANA BOAT KIDS TEAR FREE CONTINUOUS SPF 50 
avobenzone and homosalate and octinoxate and octisalate and octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE0.03 g  in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE0.15 g  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.075 g  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE0.05 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE 
WATER 
CAPRYLYL GLYCOL 
MEDIUM-CHAIN TRIGLYCERIDES 
PROPYLENE CARBONATE 
GLYCERIN 
.ALPHA.-TOCOPHEROL ACETATE, D- 
SODIUM ASCORBYL PHOSPHATE 
VITAMIN A PALMITATE 
SODIUM CITRATE 
ALOE VERA LEAF 
PHENOXYETHANOL 
METHYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
ISOBUTYLPARABEN 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:17630-2004-1170 g in 1 CAN
2NDC:17630-2004-2226 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/22/2009
Labeler - Accra-Pac, Inc. (024213616)
Establishment
NameAddressID/FEIOperations
Accra-Pac, Inc.024213616MANUFACTURE

Revised: 03/2010
 
Accra-Pac, Inc.

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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