SUNZONE FAMILY SPF 30 BROAD SPECTRUM- octinoxate and avobenzone 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 sunscreen SPF 30

Active Ingredients

Octinoxate 2.0%

Avobenzone 0.75%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

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

Stop Use and ask a doctor if irritation or rash 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 envenly 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Use in a well-ventilated area

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 broad spectrum SPF of 15 or higher and other sun

prtection measures including:

  • Limit time in the sun, especially from 10 am - 2 pm
  • Wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 Months: ASK A DOCTOR

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis Leaft Extract, Aminomethyl Propanol, Ammonium Acryloldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzonate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (Safflower) Oleosomes, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate (Vitamin E), Water

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

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

Can Label

SUNZONE FAMILY SPF 30  BROAD SPECTRUM
octinoxate and avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-235
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.70 g  in 235 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.76 g  in 235 g
Inactive Ingredients
Ingredient Name Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50021-235-01 235 g in 1 TUBE
2 NDC:50021-235-02 235 g in 1 TUBE
3 NDC:50021-235-03 235 g in 1 TUBE
4 NDC:50021-235-04 235 g in 1 TUBE
5 NDC:50021-235-05 235 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/12/2012
Labeler - Empack Spraytech Inc (252047519)
Registrant - Empack Spraytech Inc (252047519)
Establishment
Name Address ID/FEI Business Operations
Empack Spraytech Inc 252047519 manufacture(50021-235)

Revised: 11/2012
Document Id: 84b3de68-9b88-46d9-9234-a13925f2ec56
Set id: 4595c749-d9b8-4b39-ac9a-9d873ffee93f
Version: 2
Effective Time: 20121112
 
Empack Spraytech Inc