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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50021-015
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	2.35 g in 235 g
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1.18 g in 235 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50021-015-01	235 g in 1 TUBE	None
2	NDC:50021-015-02	235 g in 1 TUBE	None
3	NDC:50021-015-03	235 g in 1 TUBE	None
4	NDC:50021-015-04	235 g in 1 TUBE	None
5	NDC:50021-015-05	235 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/18/2012	12/17/2012

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Operations
Empack Spraytech Inc.		252047519	manufacture

Revised: 11/2012 Empack Spraytech Inc.