SUNZONE SPF 15 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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Active Ingredient

Avobenzone........0.50%

Octinoxate..........1.0%

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 irritaion or rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Posion Contro 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 Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Carthamus Tinctorius (safflower) Oleosomes, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Tocopheryl acetate(Vitamin E), Water

Information

Protect this product formexcessive heat and direct sun

May stain some fabrics or surfaces

Question and 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

SunZone Sunscreen Lotion

SPF 15 Broad Spectrum UVA/UVB Protection

Water Resistant (80 Minutes)

Ligh, Non-greasy

Patented Oleosome Technology derived from Plant Seeds

8fl oz(237mL)

image description


SUNZONE SPF 15  BROAD SPECTRUM
octinoxate and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.35 g  in 235 g
AVOBENZONE (AVOBENZONE) AVOBENZONE1.18 g  in 235 g
Inactive Ingredients
Ingredient NameStrength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
PHENYL TRIMETHICONE 
C12-15 ALKYL BENZOATE 
WATER 
ALOE VERA LEAF 
CAMELLIA OLEIFERA LEAF 
GLYCERIN 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50021-015-01235 g in 1 TUBENone
2NDC:50021-015-02235 g in 1 TUBENone
3NDC:50021-015-03235 g in 1 TUBENone
4NDC:50021-015-04235 g in 1 TUBENone
5NDC:50021-015-05235 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/18/201212/17/2012

Labeler - Empack Spraytech Inc. (252047519)
Registrant - Empack Spraytech Inc. (252047519)
Establishment
NameAddressID/FEIOperations
Empack Spraytech Inc.252047519manufacture

Revised: 11/2012 Empack Spraytech Inc.