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  5. Label Information: Sunzone Family Spf 60 Broad Spectrum

FDA Label for Sunzone Family Spf 60 Broad Spectrum

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WARNINGS AND PRECAUTIONS
    6. OTC - STOP USE
    7. KEEP OUT OF REACH OF CHILDREN.
    8. INDICATIONS & USAGE
    9. DOSAGE & ADMINISTRATION
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS

Sunzone Family Spf 60 Broad Spectrum Product Label

The following document was submitted to the FDA by the labeler of this product Empack Spraytech Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Warnings And Precautions



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


Otc - Stop Use



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


Indications & Usage



  • 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

Dosage & Administration



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)


* Please review the disclaimer below.