Label: SUNSCREEN- zinc oxide sunscreen 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 July 15, 2020

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  • 50g Suntegrity Sunstick SPF30

    50G Suntegrity Sunstick SPF30

  • 50g Suntegrity Sunstick Drug Label SPF30

    50g Suntegrity Sunstick Drug Label SPF30

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-174-2750 g in 1 TUBE; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/31/2018
    Labeler - Private Label Select Ltd CO (005415463)
    Registrant - Private Label Select Ltd CO (005415463)
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