SUNZONE KIDS SPF 45 BROAD SPECTRUM- octocrylene, octisalate, homosalate, avobenzone and oxybenzone aerosol, spray

SunZone Kids SPF 45 by

Drug Labeling and Warnings

SunZone Kids SPF 45 by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone....2.0%

Homosalate.....10%

Octisalate........5.0%

Octocrylene.....2.0%

Oxybenzone....5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

if used as directed with other sun protection measures (see direction), decrease the risk of skin cancer and early skin aging by the sun

Warnings

For external use only

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

Do not use on damaged or broken skin

When using this product keep away from face to avoid breathing it.

Do not punture or incinerate. Contents under pressure

Do not store at temperatures above 120 F

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 Posion Control Center right away

Directions

Inactive Ingredients

Acrylates Copolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Bisabolol,

Bis-Hydroxyethoxypropyl Dimethicone, Camellia Oleifera (Japanese Green Tea) Leaf Extract,

Ethylhexylglycerin, Diethylhexyl 2,6-Naphthalate, Fragrance, Phenoxyethanol, Tocopherol Acetate (Vitamin E)

Other Information

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Questions or Comments

call toll free 1-866-923-2665

Empack Spraytech Inc.

98 Walker Drive, Brampton, Ontario

L6T 4H6

www.sunzone.ca

Made in Canada

Please Recycle

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNZONE KIDS SPF 45  BROAD SPECTRUM
octocrylene, octisalate, homosalate, avobenzone and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.0 g  in 150 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.5 g  in 150 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15.0 g  in 150 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 150 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	7.5 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-151-01	150 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/19/2012

Labeler - Empack Spraytech Inc (252047519)

Registrant - Empack Spraytech Inc (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc		252047519	manufacture(50021-151)