SUNZONE SPF-60 BROAD SPECTRUM- avobenzone and octinoxate lotion 
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.

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Drug Facts for SunZone Sunscreen SPF 60

Active Ingredients

Avobenzone......3%

Octinoxate........4%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

When using the product do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if irritaion occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Posion Control Center right away

Directions
  • Apply liberally and spread evenly 15 minutes before sun exposure
  • Reapply after 80 minutes of swimmin or sweating
  • immediately after swimming, towel drying
  • At least every 2 hours

SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin damage. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including;

  • Limit time in the sun, especially from 10 a.m-2p.m
  • Wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: ASK A DOCTOR

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (safflower) Oleosomes, dl-alpha Tocopheryl acetate, Ethylhexylglycerin, fragrance, glycerin, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Phenyl Trimethicone, Water

Information

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Question 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

Labels

SUNZONE SPF-60  BROAD SPECTRUM
avobenzone and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9.36 g  in 234 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE7.02 g  in 234 g
Inactive Ingredients
Ingredient NameStrength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GLYCERIN (UNII: PDC6A3C0OX)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-234-01234 g in 1 TUBE
2NDC:50021-234-02234 g in 1 TUBE
3NDC:50021-234-03234 g in 1 TUBE
4NDC:50021-234-04234 g in 1 TUBE
5NDC:50021-234-05234 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/13/2012
Labeler - Empack Spraytech Inc. (252047519)
Registrant - Empack Spraytech Inc. (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc.252047519manufacture(50021-234)

Revised: 11/2012
Document Id: 89797ab4-0766-4f9b-b313-e59b02004923
Set id: 9ee30b14-f196-4ec6-b307-92d731539fc1
Version: 3
Effective Time: 20121113
 
Empack Spraytech Inc.