Label: MEDICATED FADE CREME WITH SUNSCREEN- hydroquinone and octinoxate cream

  • 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 October 26, 2015

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  • PRINCIPAL DISPLAY PANEL

    FadeCreme

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Hydroquinone U.S.P. 2%

  • Purpose

    Skin Lightener

  • Active Ingredient

    Octinoxate 2.5%

  • Purpose

    Sunscreen

  • Uses:

    • Lightens dark discolorations on the skin such as age spots, dark patches or freckles that may occur from medication, pregnancy or exposure to the elements.
    • Contains a sunscreen to help prevent darkening from reoccurring.
  • Warnings

    For External use only. Avoid contact with eyes. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

  • Do Not use on

    children under 12 years of age unless directed by a doctor.

  • Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a doctor before use.

  • Questions or Comments?

    1-800-423-0306 or sales@bluefieldInc.com

  • Directions

    • Spread a thin layer into patches on face, hands, arms or body..
    • Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident.
    • Not for use on children under 12 except on doctor's intructions.
  • Inactive Ingredients

    Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).

  • INGREDIENTS AND APPEARANCE
    MEDICATED FADE CREME WITH SUNSCREEN 
    hydroquinone and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16708-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16708-002-011 in 1 BOX
    1113.5 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A10/26/2015
    Labeler - Bluefield Associates, Inc. (626594667)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bluefield Associates, Inc.626594667manufacture(16708-002)
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