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Name:Banana Boat Ultramist Baby Tear Free Continuous Spf 50
Manufacturer:Accra-pac, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Banana Boat UltraMist Baby Tear Free Continuous Spray SPF 50

BANANA BOAT ULTRAMIST BABY TEAR FREE CONTINUOUS SPF 50 - avobenzone, homosalate, octinoxate, octisalate and octocrylene spray 
Accra-Pac, Inc.

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 UltraMist Baby 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

  • shake well before use
  • 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

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

PRINCIPAL DISPLAY PANEL

Lotion
UltraMist®
Banana Boat®
Baby
Tear Free®
Continuous Spray Sunscreen
SPF/UVB 50
AvoTriplexTM
UVA Protection
3-Way Protection
Sun-TestedTM, Sun-ProvenTM
No Tearing – Alcohol Free
Very Water Resistant
NET WT. 6 OZ. (170 g)

PRINCIPAL DISPLAY PANEL
Banana Boat UltraMist Baby Tear Free Continuous Spray SPF 50


BANANA BOAT ULTRAMIST BABY TEAR FREE CONTINUOUS SPF 50 
avobenzone and homosalate and octinoxate and octisalate and octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 0.03 g  in 1 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.15 g  in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 g  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 0.05 g  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.024 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
ISOBUTANE  
WATER  
CAPRYLYL GLYCOL  
MEDIUM-CHAIN TRIGLYCERIDES  
PROPYLENE CARBONATE  
GLYCERIN  
.ALPHA.-TOCOPHEROL ACETATE, D-  
SODIUM ASCORBYL PHOSPHATE  
VITAMIN A PALMITATE  
SODIUM CITRATE  
SODIUM CHLORIDE  
ALOE VERA LEAF  
PHENOXYETHANOL  
METHYLPARABEN  
BUTYLPARABEN  
ETHYLPARABEN  
PROPYLPARABEN  
ISOBUTYLPARABEN  
EDETATE DISODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17630-2003-1 170 g in 1 CAN None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 10/22/2009

Labeler - Accra-Pac, Inc. (024213616)
Establishment
Name Address ID/FEI Operations
Accra-Pac, Inc. 024213616 MANUFACTURE

Revised: 03/2010 Accra-Pac, Inc.



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


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