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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

Image

SUNZONE KIDS SPF 45  BROAD SPECTRUM
octocrylene, octisalate, homosalate, avobenzone and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-151
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 150 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.5 g  in 150 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15.0 g  in 150 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 150 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE7.5 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-151-01150 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/2012
Labeler - Empack Spraytech Inc (252047519)
Registrant - Empack Spraytech Inc (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc252047519manufacture(50021-151)

Revised: 12/2012
Document Id: 84c7e96a-ba3d-4eaa-bce0-eb882e5bf6c7
Set id: 4ebf1586-d6fd-449e-bd88-ca175ef0bf52
Version: 2
Effective Time: 20121217
 
Empack Spraytech Inc