KINESYS (ZINC OXIDE) CREAM [WILC HEALTHCARE INC]

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KINESYS (ZINC OXIDE) CREAM [WILC HEALTHCARE INC]
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NDC 61481-0036-2
Set ID a32b44c3-eda0-48ea-95fc-250a2c2396ca
Category HUMAN OTC DRUG LABEL
Packager Wilc Healthcare Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredient

    Zinc Oxide 25% 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

    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

    • Apply generously and spread evenly to all exposed skin 20 minutes before sun exposure

    Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    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

    Aloe Barbadensis Lead Extract, Bisabolol, Beeswax, Capric/Caprylic Triglyceride, Coconut Oil, Peppermint Oil, Polyhydroxystearic acid and Isostearic acid, Rosemary Leaf Oil, Sunflower seed oil, Tocopherols.

  • Other Information

    • protect the product in this container from excessive heat and direct sun.
  • Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 61481-0036-2

    KINeSYS Performance SUNSCREEN

    CLEAR ZINC WITH 25% NATURAL ZINC OXIDE

    BROAD SPECTRUM SPF 30

    UVA+UVB

    PEPPERMINT AND ROSEMARY

    80 MINS WATER AND SWEAT RESISTANT

    2 OZ (60 g)

    Label

  • INGREDIENTS AND APPEARANCE
    KINESYS 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61481-0036-260 g in 1 JAR; Type 0: Not a Combination Product09/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/26/2018
    Labeler - Wilc Healthcare Inc (203499140)
    Registrant - Wilc Healthcare Inc (203499140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0036)
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