THE VENETIAN THE PALAZZO BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octisalate, avobenzone, octocrylene spray

The Venetian The Palazzo by

Drug Labeling and Warnings

The Venetian The Palazzo by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120º F.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame or while smoking

Directions

• Spray liberally and spread evenly 15 minutes before sun exposure
• Hold container 4 to 6 inches from the skin to apply
• Do not spray directly into face. Spray on hands then apply to face.
• Do not apply in windy conditions
• Use in well-ventilated area
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours.
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protecion measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Diethylhexyl 2,6-Naphthalate, Mineral Oil, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• Protect this product from excessive heat and direct sun
• Avoid spraying on fabrics - could cause discoloration
• Store at 20° to 25°C (68° to 77°F)

Questions or Comments?

Call toll free 1-800-950-2563 or visit www.aloeup.com

Aloe up Sport Performace Sunscreen Broad spectrum SPF 50

INGREDIENTS AND APPEARANCE

THE VENETIAN THE PALAZZO  BROAD SPECTRUM SPF 50 SUNSCREEN
homosalate, octisalate, avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.07 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.17 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.95 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	125.85 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
MINERAL OIL (UNII: T5L8T28FGP)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0256-4	177 mL in 1 CAN; Type 0: Not a Combination Product	08/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	08/28/2015

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	manufacture(13630-0256) , label(13630-0256) , pack(13630-0256) , analysis(13630-0256)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	label(13630-0256) , pack(13630-0256)