BANANA BOAT PROTECTIVE DRY SPF 15- avobenzone and octocrylene and oxybenzone oil

Banana Boat Protective Dry SPF 15 by

Drug Labeling and Warnings

Banana Boat Protective Dry 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

Octocrylene  0.05mL / 1mL

Oxybenzone 0.03mL / 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

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.

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

SD Alcohol 40, Mineral Oil, C12-15 Alkyl Lactate, Trimethylolpropane Tricaprylate/ Tricaprate, Ethylhexyl Benzoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Cetearyl Ethylhexanoate, Dicaprylyl Carbonate, Acrylates/ Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A), Aloe Barbadensis Leaf Extract, Fragrance

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

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

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
protective
TANNING
DRY OIL
Continuous Spray Sunscreen
SPF/UVB 15
AvoTriplexTM
High UVA
3-Way ProtectionTM
Sun-Tested, Sun-ProvenTM
Fast & Even Coverage
Coconut & Grape Seed Oils
Very Water Resistant
6 FL. OZ. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT PROTECTIVE DRY SPF 15 
avobenzone and octocrylene and oxybenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2017
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.05 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17630-2017-1	177 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/17/2008

Labeler - Accra-Pac, Inc. (024213616)

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