SUNZONE FAMILY SPF 60 BROAD SPECTRUM- octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray

SUNZONE FAMILY SPF 60 by

Drug Labeling and Warnings

SUNZONE FAMILY SPF 60 by is a Otc medication manufactured, distributed, or labeled by Empack Spraytech Inc., Empack Spraytech Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate .......5.0%

Octocrylene...... 5.0%

Octisalate..........5.0%

Oxybenzone..... 6.0%

Avobenzone......3.0%

Homosalate.......12.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused be the sun

Warnings

For external use only

Flammable; Do not use near heat, flame, or while smoking

Do not use on damaged of broken skin

When using this product keep away from face to avoid breathing it

Do not puncture or incinerate. Contents under pressure.

Do not store at temperatures above 120 0F

Stop use and ask a doctor if rash occurs

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away

• Spray liberally and spread evenly by hand 15 minutes before sun exposure
• Reapply
• • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Hold container 4 to 6 inches from the skin to apply
• Do not spray directly into face. Spray on hand then apply to face
• Do not apply in windy conditions
• Use in a well-ventilated area

• Sun protection measures. Spending time in the sun increase the risk of skin cancer and early skin again. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including 
• • Limit time in the sun, especially from 10 a.m - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor
  

Spray liberally and spread evenly by hand 15 minutes before sun exposure.

Other Information

• Protect this product from excessive heat and direct sun
• May stain some fabrics and surfaces

Inactive Ingredients

Acrylates Copolymer,  Alcohol Denat.,  Aloe Barbadensis Leaf Extract,  Bisabolol,

Bis-Hydroxyethoxypropyl Dimethicone, Camellia Oleifera (Japanese Green Tea) Leaf Extract,

Ethylhexylglycerin, Ethylhexyl Methoxycrylene, Fragrance, Phenoxyethanol, Tocopherol Acetate (Vitamin E)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNZONE FAMILY SPF 60  BROAD SPECTRUM
octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50021-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.75 g  in 155 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.75 g  in 155 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.75 g  in 155 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	9.30 g  in 155 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4.65 g  in 155 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	18.60 g  in 155 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEVOMENOL (UNII: 24WE03BX2T)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST) (UNII: YP714N2H05)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50021-062-01	155 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/16/2012

Labeler - Empack Spraytech Inc. (252047519)

Registrant - Empack Spraytech Inc. (252047519)

Establishment
Name	Address	ID/FEI	Business Operations
Empack Spraytech Inc		252047519	manufacture(50021-062)