KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]

KINESYS EARTHKIND SPF 30 SUNSCREEN (ZINC OXIDE) OINTMENT [KINESYS PHARMACEUTICAL INC.]
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NDC 61481-0037-3
Set ID 9b41d15a-b0c3-4e97-9c43-6a445b88fe94
Category HUMAN OTC DRUG LABEL
Packager KINeSYS Pharmaceutical Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • WARNINGS

    WARNINGS: For External Use only. Avoid Eyes. Keep out of reach of children. Discontinue use if signs of irritation appear. Do not use on infants less than six months of age.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Zinc Oxide 25.0%

  • PRINCIPAL DISPLAY PANEL

    Package Label label1.jpg

  • INGREDIENTS AND APPEARANCE
    KINESYS EARTHKIND SPF 30 SUNSCREEN 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61481-0037-390 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2011
    Labeler - KINeSYS Pharmaceutical Inc. (033044178)

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