Label: DR. YOUNG 2P PEARL BRIGHTENING BALM SPF35 PA- allantoin cream

  • 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 September 25, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    allantoin
  • INACTIVE INGREDIENT

    water, cyclopentasiloxane, cyclohexasiloxane, titanium dioxide, ethylhexyl methoxycinnamate, glycerin, dipropylene glycol, hexyl laurate, butylene glycol dicaprylate / dicaprate, cytyl peg/ppg-10/1 dimethicone, bentonite, chrysanthellum indicum extract, magnesium sulfate, zinc oxide, pearl powder, magnolia liliflora flower extract, lilium candidum flower extract, convallaria majalis bulb/root extract, shea butter, magnolia kobus bark extract, ghujopsis dolabrata branch extract, camellia sinensis leaf extract, grapefruit fruit extract, centella asiatica extract, althaea rosea flower extract, aloe barbadensis leaf extract, silica, triethoxycaprylsilane, ci 77492, ci 77491, ci 44299, ultramarines, sorbitan siostearate, tocopheryl acetate, ascorbyl glucoside, lilium candidum flower extract, ceramide 3, disodium edta, methylparaben, propylparaben, fragrance
  • PURPOSE

    UVB, UVA protection
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    After basic skin care routine, apply evenly to your face
  • WARNINGS

    When using this product
    - keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DR. YOUNG 2P PEARL BRIGHTENING BALM SPF35 PA 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-1101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CHRYSANTHELLUM INDICUM FLOWER OIL (UNII: HJ299SUZ05)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH)  
    CONVALLARIA MAJALIS BULB (UNII: 261W7X975U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MAGNOLIA KOBUS BARK (UNII: 54LVP49595)  
    THUJOPSIS DOLABRATA WHOLE (UNII: Q190548W6J)  
    BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)  
    PUMMELO (UNII: ET1TN5W71X)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43948-1101-130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/27/2012
    Labeler - The Doctors Cosmetics Co., Ltd (687479378)
    Registrant - The Doctors Cosmetics Co., Ltd (687479378)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Doctors Cosmetics Co., Ltd687479378manufacture(43948-1101)