Active Ingredients

Avobenzone 1%

Octocrylene 0.85%

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

Aloe Barbadensis Leaf Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Retinyl Palmitate, Ricinus Communis (Castor) Seed Oil, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

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

Questions or Comments?

Call toll free 1-800-950-2563

Aloe Up Dark Tanning Oil SPF 4 Sunscreen Mist

Principal Display Label

ALOE UP DARK TANNING OIL SPF 4
avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0152
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	8.02 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.817 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
VINYL ACETATE (UNII: L9MK238N77)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)

Product Characteristics
Color	yellow (Colorless to light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0152-4	177 mL in 1 CAN; Type 0: Not a Combination Product	04/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/02/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0152) , analysis(13630-0152)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0152) , pack(13630-0152)