BANANA BOAT SPORT PERFORMANCE SPF 15- avobenzone and homosalate and octinoxate and octisalate and octocrylene and oxybenzone spray

Banana Boat Sport Performance SPF 15 by

Drug Labeling and Warnings

Banana Boat Sport Performance SPF 15 by is a Otc medication manufactured, distributed, or labeled by Accra-Pac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 0.03mL / 1mL

Homosalate 0.05mL / 1mL

Octinoxate 0.05mL / 1mL

Octisalate 0.05mL / 1mL

Octocrylene 0.025mL / 1mL

Oxybenzone 0.02mL / 1mL

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

While 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.

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 way.

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

SD Alcohol 40-B, C12-15 Alkyl Benzoate, Acrylates/ Octylacrylamide, Copolymer, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Dimethyl Capramide, Fragrance

Questions or comments?

Call 1-800-SafeSun, Mon-Fri

Distributed by:
Sun Pharmaceuticals, LLC, Shelton, CT 06484
www.bananaboat.com

Manufactured by:
Accra Pac, Inc. (dba KIK Custom Products)

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
Banana
Boat®
SPORT
PerformanceTM
Active Dry ProtectTM
Continuous Spray Sunscreen
SPF/UVB 15
AvoTriplexTM
High UVA
Long-Lasting Protection
Sun-Tested, Sun-ProvenTM
Invisible, Rub-Free
Non-Greasy
Very Water/Sweat Resistant
6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT SPORT PERFORMANCE SPF 15 
avobenzone and homosalate and octinoxate and octisalate and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.05 mL  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 mL  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.025 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2005-1	177 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/02/2006

Labeler - Accra-Pac, Inc. (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra-Pac, Inc.		024213616	MANUFACTURE