Label: SUN KILLING GRAPEFRUIT- glycerin gel

  • Category: HUMAN OTC DRUG LABEL

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 March 14, 2015

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  • ACTIVE INGREDIENT

    glycerine


  • INACTIVE INGREDIENT

    water, alcohol, butylene glycol, betain, carbomer, adenosine, beta glucan, etc


  • PURPOSE

    skin protectant

    skin soothing

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    use as primary pack for moisturizing relief by applying on skin after using ampoule or serum
    gently massage for absorption


  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    SUN KILLING GRAPEFRUIT 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69663-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69663-1001-1270 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/08/2015
    Labeler - SA Cosmetic (689058611)
    Registrant - SA Cosmetic (689058611)
    Establishment
    NameAddressID/FEIBusiness Operations
    SA Cosmetic689058611manufacture(69663-1001)
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