BANANA BOAT ULTRA DEFENSE SPF 85- avobenzone and homosalate and octocrylene and oxybenzone spray

Banana Boat Ultra Defense SPF 85 by

Drug Labeling and Warnings

Banana Boat Ultra Defense SPF 85 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 0.15mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.06mL / 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-B, Cyclopentasiloxane, Cyclohexasiloxane, C12-C15 Alkyl Lactate, Trimethylolpropane Tricaprylate/Tricaprate, Dicaprylyl Carbonate, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (Vitamin A), Tocopherol, Fragrance.

Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484

PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
Ultra
DefenseTM
Sheer Protect
Continuous Spray Sunscreen
SPF/UVB 85
with Aloe Vera
AvoTriplexTM
High UVA
Long-Lasting Protection
Sun-Tested, Sun-ProvenTM
Lightweight & Rub-Free
Skin Cancer Foundation Recommended
Very Water Resistant
6 FL. OZ. (177mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT ULTRA DEFENSE SPF 85 
avobenzone and homosalate and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17630-2015
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	0.15 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.10 mL  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
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: 17630-2015-1	177 mL in 1 CAN
2	NDC: 17630-2015-2	236 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2009

Labeler - Accra-Pac, Inc. (024213616)

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