Label: DIVINE DERRIER SKIN BLEACHING CREAM- 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 7, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Hydroquinone 2% Skin lightener

  • PURPOSE

    Uses

    • Lightens skin discoloration sich as freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptions
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Stop use and ask a doctor

    • If rash occurs
  • WARNINGS

    Warnings: for external use only

    When using this product

    • Avoid contact with eyes
    • Limit sun exposure. Protect skin with a Broad-Spectrum sunscreen agent, wear protective clothing to cover bleached skin after treatment to prevent darkening from reoccuring
    • Some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a physician
    • Do not use on children under 12 years of age unless directed by a physician
    • If product consult with a doctor before use
    • If pregnant or breast-feeding
    • Speak with a healthcare professional before use

    Sunburn alert

    • This product contains an alpha-hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards
  • DOSAGE & ADMINISTRATION

    Directions

    Adult apply a small amount

  • INACTIVE INGREDIENT

    Inactive Ingredients Water(Aqua), Isopropyl Palmitate, Caprylic/capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Propanediol, Glycolic Acid, Lactic Acid, Kojic Dipalmitate, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Niacinamide, Allantoin, Ferulic Acid, Butylene Glycol, hydrogenated Lecithin, Sodium Oleate, Oligopeptide-68, Dipotassium Glycrrhizate, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Frangrance.

  • PRINCIPAL DISPLAY PANEL

    Divine Derriere Skin Bleaching Cream

    Hydroquinone 2% Skin Lightener

    50 ml - 1.7fl oz

    label

  • INGREDIENTS AND APPEARANCE
    DIVINE DERRIER SKIN BLEACHING CREAM 
    hydroquinone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    FERULIC ACID (UNII: AVM951ZWST)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    KOJIC DIPALMITATE (UNII: 13N249RWTM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-4004-150 mL in 1 JAR; Type 0: Not a Combination Product01/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/10/2019
    Labeler - Cosmetic Enterprises Ltd (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd017701475manufacture(56152-4004)