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

----------

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, Diethylhexyl 2,6- Naphthalate, Fragrance, Phenoxyethanol, Tocopherol Acetate (Vitamin E)

Label

SUNZONE SUNSCREEN SPORT SPF 60  BROAD SPECTRUM
octinoxate, octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.75 g  in 155 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.75 g  in 155 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.75 g  in 155 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE9.30 g  in 155 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4.65 g  in 155 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE18.60 g  in 155 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50021-305-01155 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2013
Labeler - Empack Spraytech Inc. (252047519)
Registrant - Empack Spraytech Inc. (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc252047519manufacture(50021-305)

Revised: 1/2013
Document Id: f08b93f6-e2dd-4457-b043-afb802ddcdc6
Set id: a86278c9-da5a-40f9-bb0b-ec8ea39e8df4
Version: 1
Effective Time: 20130102
 
Empack Spraytech Inc.