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 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 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
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 protection 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 Extract, Cocos Nucifera (Coconut) Oil,Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), 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.
Store at 20ºC to 25ºC (68ºC to 77ºF)

Questions or comments?

Call toll free 1-800-950-2563

SPF 50 C/S Sunscreen Aloe Vera

Principle Display Label

ALOE UP SPF 50 C/S SUNSCREEN WITH ALOE VERA
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0225
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	127.05 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.35 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.29 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.41 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
MINERAL OIL (UNII: T5L8T28FGP)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0225-4	183 mL in 1 CAN; Type 0: Not a Combination Product	05/22/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/22/2019

Labeler - Prime Packaging Inc (805987059)

Registrant - Prime Packaging Inc (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc		101946028	manufacture(13630-0225) , analysis(13630-0225)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging Inc		805987059	label(13630-0225) , pack(13630-0225)

Aloe Up SPF 50 C/S Sunscreen Aloe Vera