ALOE UP BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, and octocrylene 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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Purpose

Sunscreen

SPL UNCLASSIFIED SECTION

• helps prevent sunburn
• if used as directed with other sun protection measures (see DIrections), decreases the risk of skin cancer and early skin aging 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 120ºF

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 by hand 15 minutes before sun exposure.
• hold container 4 to 6 inches from the skin to apply
• do not spray 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
• Sun Protection Measures. Spending time in the sun increases your chance 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 protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve skirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	83 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	22.83 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0094-4	177 mL in 1 CAN; Type 0: Not a Combination Product	07/27/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/27/2015

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc		101946028	manufacture(13630-0094) , analysis(13630-0094)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	pack(13630-0094) , label(13630-0094)