ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN- octinoxate, oxybenzone spray

ALOE UP DARK TANNING OIL SPF 4 by

Drug Labeling and Warnings

ALOE UP DARK TANNING OIL SPF 4 by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

OCTINOXATE (2%)

OXYBENZONE (2%)

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

DIRECTIONS:

spray liberally and spread evenly 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 conditions
use in a well-ventilated 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

KEEP OUT OF REACH OF CHILDREN

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

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°F.
Stop use and ask a doctor if rash occurs.

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

Inactive Ingredients

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

Other Information

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

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP DARK TANNING OIL SPF 4  CONTINUOUS SUNSCREEN
octinoxate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CASTOR OIL (UNII: D5340Y2I9G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
MINERAL OIL (UNII: T5L8T28FGP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-216-26	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)