Label: SUNSCREEN cream

  • NDC Code(s): 84025-034-01
  • Packager: Guangzhou Yanxi Biotechnology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • DOSAGE & ADMINISTRATION

    Apply to the face or body.

  • INACTIVE INGREDIENT

    aqua

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    For external use only.

  • PURPOSE

    helps prevent sunburn

  • INDICATIONS & USAGE

    Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating, Immediately after towel drying, At least every 2 hours.

  • PRINCIPAL DISPLAY PANEL

    84025-034

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84025-034
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 mg  in 50 mL
    SQUALANE (UNII: GW89575KF9) (SQUALANE - UNII:GW89575KF9) SQUALANE5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84025-034-0160 mL in 1 TUBE; Type 0: Not a Combination Product04/29/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/29/2024
    Labeler - Guangzhou Yanxi Biotechnology Co., Ltd (632583102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yanxi Biotechnology Co., Ltd632583102manufacture(84025-034)
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