Label: KINESYS EARTHKIND SPF 30 SUNSCREEN- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 15, 2011

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  • 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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