KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]

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  • KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]

KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [WILC HEALTHCARE INC]
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NDC 61481-3001-1, 61481-3001-4
Set ID e0949325-7de1-4da4-82b6-8004916412a0
Category HUMAN OTC DRUG LABEL
Packager Wilc Healthcare Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • 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 (1.888.546.3797)
    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 from 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 conditions
    • 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 extreme temperatures. May stain or damage some fabrics and surfaces.
  • PRINCIPAL DISPLAY PANEL 

    120ML BOTTLE LABEL

    BROAD SPECTRUM SPF 30 UVA + UVB

    OIL FREE

    CLEAR SPRAY

    FOR ACTIVE SKIN

    KINeSYS

    Performance SUNSCREEN

    BROAD SPECTRUM SPF30

    FRAGRANCE FREE

    80 MINS WATER & SWEAT RESISTANT

    4FL OZ(120ml)

    NDC 61481-3001-4

    Label

  • INGREDIENTS AND APPEARANCE
    KINESYS BROAD SPECTRUM SPF 30 ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE 
    octinoxate, octocrylene, octisalate, and avobenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61481-3001-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2017
    2NDC:61481-3001-4120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2017
    3NDC:61481-3001-95 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Labeler - Wilc Healthcare Inc (203499140)
    Registrant - Wilc Healthcare Inc (203499140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmaceutical Research Laboratory Inc256797309manufacture(61481-3001)
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