Label: SUNSCREEN- sunscreen lotion 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 May 7, 2018

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  • PRINCIPAL DISPLAY PANEL

    EMS SPF30 Sunscreen

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    sunscreen lotion ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-165-2084 g in 1 TUBE; Type 0: Not a Combination Product05/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/07/2018
    Labeler - Private Label Select Ltd CO (005415463)
    Registrant - Private Label Select Ltd CO (005415463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Private Label Select Ltd CO005415463manufacture(62932-165)