Label: AMBI FADE NORMAL SKIN- hydroquinone and octinoxate cream

  • NDC Code(s): 0187-5479-02, 0187-5479-30, 0187-5479-99
  • Packager: Valeant Pharmaceuticals North America LLC
  • 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 February 3, 2014

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

  • Active Ingredients

    Hydroquinone (2%)

    Octinoxate (2%)

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  • Purpose

    Skin Bleaching Agent

    Sunscreen

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  • Uses

    For the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or pigment that may occur in pregnancy or from the use of oral contraceptives.
    Contains a sunscreen to help prevent darkening from reoccurring.
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  • Warnings

    For external use only.

    When using this product

    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.
    This product is not for use in the prevention of sunburn.

    Keep out of reach of children

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

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  • Directions

    Adults: Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
    Children under 12 years of age: do not use unless directed by a doctor.
    Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.
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  • Other Information

    Store at room temperature.

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  • Inactive Ingredients

    Water, Glycerin, Isopropyl Myristate, Stearic Acid, Cyclopentasiloxane, Cetyl Alcohol, Betaine, Hydroxyethyl Urea, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Sodium Metabisulfite, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Fragrance, Tocopheryl Acetate, Methylparaben, Disodium EDTA, Lactic Acid, Propylparaben, Ethylparaben, PEG-16 Soy Sterol, Sodium Ascorbyl Phosphate, Butylene Glycol, Glycine Soja (Soybean) Protein

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  • Questions/Comments?

    1-800-321-4576

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  • Package/Label Principal Display Panel

    AMBI®

    SKINCARE

    Fade Cream

    Fades dark spots for even, natural skin tone

    With Vitamin E and Alpha Hydroxy Acid

    NORMAL SKIN

    NET WT. 2 OZ. (56g)

    56g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    AMBI FADE  NORMAL SKIN
    hydroquinone and octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-5479
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 20 mg  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Betaine (UNII: 3SCV180C9W)  
    Hydroxyethyl Urea (UNII: MBQ7DDQ7AR)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Ethylparaben (UNII: 14255EXE39)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Soybean (UNII: L7HT8F1ZOD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0187-5479-02 1 in 1 CARTON
    1 56 g in 1 TUBE
    2 NDC:0187-5479-99 1 in 1 CARTON
    2 56 g in 1 TUBE
    3 NDC:0187-5479-30 24 in 1 CARTON
    3 3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part358A 02/04/2014
    Labeler - Valeant Pharmaceuticals North America LLC (042230623)
    Establishment
    Name Address ID/FEI Business Operations
    Accupac, Inc. 071609663 MANUFACTURE(0187-5479)
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