SUNZONE BABY SPF 30 SUNSCREEN BROAD SPECTRUM- octinoxate and avobenzone lotion

SunZone Baby SPF 30 Sunscreen by

Drug Labeling and Warnings

SunZone Baby SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNZONE BABY SPF 30 SUNSCREEN  BROAD SPECTRUM
octinoxate and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-237
Route of Administration	TOPICAL

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: 50021-237-01	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	11/12/2012

Labeler - Empack Spraytech Inc (252047519)

Registrant - Empack Spraytech Inc (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc		252047519	manufacture(50021-237)