SUNZONE FAMILY SPF 15 BROAD SPECTRUM- octinoxate and avobenzone lotion

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Drug Labeling and Warnings

Array by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

SunZone Family 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)

INGREDIENTS AND APPEARANCE

SUNZONE FAMILY SPF 15  BROAD SPECTRUM
octinoxate and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.35 g  in 235 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.18 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)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-016-01	235 g in 1 TUBE
2	NDC: 50021-016-01	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	11/14/2012

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc.		252047519	manufacture(50021-016)