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Kinesys (KINeSYS Pharmaceuticals Inc.)

Available Formats

Dosage Form Package Information Links
SPRAY 120 mL in 1 BOTTLE, SPRAY (61481-3002-4) Label Information
SPRAY 30 mL in 1 BOTTLE, SPRAY (61481-3002-1) Label Information

Complete Kinesys Information

  • Active Ingredients

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


  • 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

  • Questions or Comments?

    1-888-KINeSYS [546.3797]
    www.kinesysactive.com


  • Warnings

    For external use only

    Do not use
    • on damaged or broken skin

    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.

    Do not use

    near flame or while smoking


  • Directions

    • Hold container 4 to 6 inches away from the skin to apply.
    • apply generaously 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, Octyl Palmitate, Tocopherols, VP/ Hexadecene Copolymer.


  • Other Information

    • protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    NDC 61481-3002-1

    BROAD SPECTRUM SPF 30

    KIDS Alcohol–Free Spray Sunscreen

    KINeSYS®

    Fragrance-Free // Oil-Free

    • Clear Spray
    • Preservative-Free

    BROAD SPECTRUM SPF 30

    WATER RESISTANT (80 MINUTES)

    1.0 FL OZ (30 mL)

    Label

    NDC 61481-3002-4

    BROAD SPECTRUM SPF 30

    KIDS Alcohol–Free Spray Sunscreen

    KINeSYS®

    Fragrance-Free // Oil-Free

    Clear Spray
    Preservative-Free

    BROAD SPECTRUM SPF 30

    WATER RESISTANT (80 MINUTES)

    4.0 FL OZ (120 mL)

    Label 1


  • INGREDIENTS AND APPEARANCE
    KINESYS  BROAD SPECTRUM SPF 30 KIDS ALCOHOL-FREE SUNSCREEN
    octinoxate, octocrylene, octisalate, and avobenzone spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-3002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61481-3002-4 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2017
    2 NDC:61481-3002-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 06/01/2017
    Labeler - Wilc Healthcare Inc (203499140)
    Registrant - Wilc Healthcare Inc (203499140)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmaceutical Research Laboratory Inc 256797309 manufacture(61481-3002)