Your browser does not support JavaScript! SUNZONE FAMILY SPF 30 BROAD SPECTRUM (OCTINOXATE AND AVOBENZONE) LOTION [EMPACK SPRAYTECH INC]
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SUNZONE FAMILY SPF 30 BROAD SPECTRUM (octinoxate and avobenzone) lotion
[Empack Spraytech Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50021-235
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE4.70 g  in 235 g
AVOBENZONE (AVOBENZONE) AVOBENZONE1.76 g  in 235 g
Inactive Ingredients
Ingredient NameStrength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
PHENYL TRIMETHICONE 
WATER 
ALOE VERA LEAF 
CAMELLIA OLEIFERA LEAF 
GLYCERIN 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
AMINOMETHYLPROPANOL 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-235-01235 g in 1 TUBE
2NDC:50021-235-02235 g in 1 TUBE
3NDC:50021-235-03235 g in 1 TUBE
4NDC:50021-235-04235 g in 1 TUBE
5NDC:50021-235-05235 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/12/2012
Labeler - Empack Spraytech Inc (252047519)
Registrant - Empack Spraytech Inc (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc252047519manufacture(50021-235)

Revised: 11/2012
 
Empack Spraytech Inc

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