Label: ADVANCED LIGHTNING- octinoxate and hydroquinone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 5, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydroquinone 2%

  • Purpose

    Skin Lightener

  • Uses

    • helps fade skin discoloration.
    • helps even pigmentation.
    • use regularly at night.
  • Warnings

    for external use only

    for adult use only

    When using this product

    • keep out of eyes, rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Apply thin layer on affected areas after cleansing.
    • Follow with moisturizer.
    • Wear sunscreen daily.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Butylene Glycol, Cetyl Alcohol, Citric Acid, Coco-Caprylate/Caprate, Cucumis Sativus (Cucumber) Oil, DEA-Cetyl Phosphate, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Ethylhexyl Methoxycinnamate, Glycerin, Hydrogenated Vegetable Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Magnesium Ascorbyl Phosphate, Methylparaben, Morus Bombycis Root Extract, Propylene Glycol, Propylparaben, Rosa Damascena Flower Water, Saxifraga Sarmentosa Extract, Scutellaria Baicalensis Root Extract, Sodium Bisulfite, Sodium PCA, Sodium Sulfite, Stearic Acid, Tocopherol, Tocopheryl Acetate, Vitis Vinifera (Grape) Fruit Extract, Water (Aqua)

  • PRINCIPAL DISPLAY PANEL - 56.7 g Carton

    lightening perfection crème

    SKINCARE
    INTENSIVE

    Net Wt 2 Oz / 56.7 g

    Principal Display Panel - 56.7 g Carton
  • INGREDIENTS AND APPEARANCE
    ADVANCED LIGHTNING 
    octinoxate and hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.02 g  in 1 g
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CUCUMBER (UNII: YY7C30VXJT)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24623-042-2256.7 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/01/2005
    Labeler - CBI Laboratories, Inc (623704368)
    Establishment
    NameAddressID/FEIBusiness Operations
    CBI Laboratories, Inc.623704368MANUFACTURE
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