Banana Boat Ultra Defense Sheer Protect Spf 50 (Avobenzone And Octocrylene And Oxybenzone) Spray [Accra-Pac, Inc.] -

BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50 (AVOBENZONE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]
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NDC	17630-2033-1, 17630-2033-2
Set ID	a84fa20b-3e1d-45de-8f6d-858738319cb2
Category	HUMAN OTC DRUG LABEL
Packager	Accra-Pac, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Avobenzone 0.03mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.05mL / 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, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl, Thiosulfate Silica, Octyldodecanol, Silica, Fragrance.
Questions or Comments?

Call 1-800 SafeSun, Mon-Fri

MADE IN U.S.A.
Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484
© 2009 Sun Pharmaceuticals, LLC
PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
Ultra
DefenseTM
Sheer Protect
Continuous Spray Sunscreen
SPF/UVB 50 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. (177 mL)

INGREDIENTS AND APPEARANCE

BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50
avobenzone and octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17630-2033
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.10 mL in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.05 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description
Packaging
1	NDC:17630-2033-1	177 mL in 1 CAN
2	NDC:17630-2033-2	236 mL in 1 CAN

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	09/15/2009

Labeler - Accra-Pac, Inc. (024213616)

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

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Medic

BANANA BOAT ULTRA DEFENSE SHEER PROTECT SPF 50 (AVOBENZONE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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