ALOE UP DARK TANNING OIL SPF 4- octinoxate and oxybenzone spray

Aloe Up by

Drug Labeling and Warnings

Aloe Up 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

Octinoxate 2 %, and Oxybenzone 2 %

PURPOSE

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 120 oF

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 by hand 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 condiions
• use in well-ventillated area
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil, Retinyl Palmitate, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate

Other information

• protect this product from excesive heat and direct sun
• avoid spraying on fabrics - could cause discoloration

QUESTIONS

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Aloe Up
DARK

TANNING

OIL

SPF

4

CONTINUOUS SPRAY

SUNSCREEN

MOISTURE

RICH FORMULA

WATER RESISTANT

(80 MINUTES)

VITAMIN A, C & E

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

ALOE UP  DARK TANNING OIL SPF 4
octinoxate and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	16.6 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	16.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CASTOR OIL (UNII: D5340Y2I9G)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0041-4	177 mL in 1 CAN; Type 0: Not a Combination Product	01/05/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/05/2009

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0041) , analysis(13630-0041)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0041) , pack(13630-0041)