SUNZONE SPF 50 Broad Spectrum

Dosage form: aerosol, spray
Ingredients: HOMOSALATE 18g in 180g, OCTOCRYLENE 3.6g in 180g, OCTISALATE 9g in 180g, OXYBENZONE 9g in 180g, AVOBENZONE 3.6g in 180g
Labeler: Empack Spraytech Inc.
NDC Code: 50021-182

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.

Drug Facts for Sunscreen SPF 50

Active IngredientsOctocrylene        5.0%

Octisalate           2.0%

Oxybenzone       1.5%

Avobenzone       3.0%

Homosalate        10%

Purpose

Sunscreen

Uses
  • Helps prevent sunburns
  • If used as directed with other sun protection measures ( See directions),  decreases the risk of skin cancer and early aging caused by the sun.

Warning
  •  Flammable.Do not use near heat, flame or while smoking.
  •  Do not use on damaged or 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 1200 F

  •  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 the container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. spray on hands 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 your 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

Dosage & Administration

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

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)

Other Information

    * Provides broad-spectrum UVA/UVB Protection
    * Ultra light sheer mist, and a non-greasy finish
    * Applies easily to hard to reach areas
    * Oil-free
    * PABA free
    * Paraben Free


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

Question Or Comments

Call toll free 1-866-923-2665

Website: www.sunzone.com


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SUNZONE SPF 50  BROAD SPECTRUM
octocrylene, octisalate, oxybenzone, avobenzone and homosalate. aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-182
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE18 g  in 180 g
OCTOCRYLENE (OCTOCRYLENE ) OCTOCRYLENE 3.6 g  in 180 g
OCTISALATE (OCTISALATE) OCTISALATE9 g  in 180 g
OXYBENZONE (OXYBENZONE) OXYBENZONE9 g  in 180 g
AVOBENZONE (AVOBENZONE) AVOBENZONE3.6 g  in 180 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ALOE VERA LEAF 
LEVOMENOL 
CAMELLIA JAPONICA LEAF 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:50021-182-03180 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/18/2011
Labeler - Empack Spraytech Inc. (252047519)
Registrant - Empack Spraytech Inc. (252047519)
Establishment
NameAddressID/FEIOperations
Empack Spraytech Inc.252047519manufacture

Revised: 11/2011
 
Empack Spraytech Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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