FDA Label for Kinesys

View Indications, Usage & Precautions

Kinesys Product Label

The following document was submitted to the FDA by the labeler of this product Wilc Healthcare 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



Avobenzone 2.5% w/w
Octinoxate 7.5% w/w
Octisalate 5.0% w/w
Octocrylene 7.5% w/w


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 by the sun

Warnings



For external use only


Do Not Use



  • on damaged or broken skin
  • near flame or while smoking


When Using This Product



  • keep out of eyes. Rinse with water to remove.

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.


Directions



  • Hold container 4 to 6 inches from the skin to apply
  • Spray generously 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
    • Do not spray directly onto the face. Spray into hands, and apply to the face.
    • Do not apply in windy condition
    • Use in well-ventilated area
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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


Inactive Ingredients



Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.


Other Information



  • protect the product in this container from extreme temperatures. May stain or damage some fabrics and surfaces.

Questions Or Comments?



Call toll free 1.888.KINeSYS [546.3797] www.kinesysactive.com


Principal Display Panel - 30 Ml Bottle Label



NDC 61481-3006-1

BROAD SPECTRUM SPF 30 UVA+ UVB

OIL FREE CLEAR SPRAY FOR ACTIVE SKIN

KINeSYS®

Performance SUNSCREEN

BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA

80 MINS WATER AND SWEAT RESISTANT

1.0 FL OZ (30 mL)

NDC 61481-3006-4

BROAD SPECTRUM SPF 30 UVA+ UVB

OIL FREE CLEAR SPRAY FOR ACTIVE SKIN

KINeSYS®

Performance SUNSCREEN

BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA

80 MINS WATER AND SWEAT RESISTANT

4.0 FL OZ (120 mL)


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