SUNZONE BABY SUNSCREEN SPF-60 BROAD SPECTRUM- avobenzone and octinoxate lotion

SunZone Baby Sunscreen SPF-60 by

Drug Labeling and Warnings

SunZone Baby Sunscreen SPF-60 by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone......3%

Octinoxate........4%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

When using the product do not get into eyes. If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if irritaion 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 evenly 15 minutes before sun exposure
• Reapply after 80 minutes of swimmin or sweating
• immediately after swimming, towel drying
• At least every 2 hours

SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin damage. To decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including;

• Limit time in the sun, especially from 10 a.m-2p.m
• 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, dl-alpha Tocopheryl acetate, Ethylhexylglycerin, fragrance, glycerin, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Phenyl Trimethicone, Water

Information

Protect this product from excessive heat and direct sun

May stain some fabrics or surfaces

Question or 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

INGREDIENTS AND APPEARANCE

SUNZONE BABY SUNSCREEN SPF-60  BROAD SPECTRUM
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	9.36 g  in 234 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	7.02 g  in 234 g

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
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: 50021-241-01	234 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/13/2012

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc.		252047519	manufacture(50021-241)