Label: TOTAL WHITE BRIGHTENING - octinoxate and hydroquinone cream 

  • NDC Code(s): 53218-002-02, 53218-002-03, 53218-002-04
  • Packager: YZY Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • Active Ingredients

    Hydroquinone 2%
    Ethylhexyl Methoxycinnamate 3%

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  • Purpose

    Hydroquinone 2% ............................... Skin Lightener
    Ethylhexyl Methoxycinnamate 3% ..... Sunscreen

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  • Uses:

    Gradually fades skin discolorations in dark areas, age spots, freckles, liver spots and dark areas that can occur while using oral contraceptives

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  • Warnings:

    For external use only

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  • Do Not Use

    To prevent sunburn • On inflamed or broken skin

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  • When using this product

    • Mild irritation may occur
    • Avoid contact with eyes. If contact occurs rinse with water.
    • Avoid unnecessary sun exposure and use a sunscreen or protective clothing

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  • Stop use and consult a doctor if

    • A gradual blue-black darkening of the skin ocurs
    • Irritation becomes severe 
    • No improvement is seen after 3 months

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  • If pregnant or breast feeding,

    consult a health professional before use.

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  • Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a poison control center immediately.

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  • Directions

    • If skin is sensitive, test on a small area inside the elbow overnight before use.
    • adults and children 12 years and older apply as a thin layer to affected area twice daily or as directed by a doctor. 
    • Children under 12 years of age ask a doctor before use.

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  • Inactive ingredients

    Water (Aqua), Coco-Caprylate/Caprate, Stearic Acid, PEG-8, Cetyl Alcohol, Stearyl Stearate, Glyceryl Stearate, PEG-100, Propylene Glycol, Kojic Acid, Daucus Carota Sative (Carrot) Seed Oil, Vaccinium Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Pentetic Acid, Zea Mays (Corn) Oil, Xanthan Gum, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Beta-Carotene, Sodium Sulfite, Sodium Metabisulfite, Tetrasodium EDTA, Methylparaben, Propylparaben, DMDM Hydantoin, Fragrance (Parfum)

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  • PRINCIPAL DISPLAY PANEL

    Total White
    Brightening Body Cream
    Lightens Skin
    Natural Bio-vegetal Activation
    With Carrot Oil
    8 OZ e 227 g Distributed by Heaven Scent, Miami FL
    shimonb@yzyinc.com 877-999-3534
    Tottenham, London N17 OQT, UK
    MADE IN USA

    Total White 8 oz. Cream Label

    Total White
    Brightening Body Cream

    Total White 8 oz. Cream Drug Facts

    Total White Brightening Cream diminishes the appearance of dark spots and skin discolorations caused by acne, aging, sun damage and pregnancey.  This rich cream is formulated with Carrot Oil and Vitamins A and E; it effectivly moisturizes and nourishes your skin, while it protects from future damage.  It safely brightens and evens dark spots for younger, healthier, more radiant looking skin.

    Total White 16 oz. Cream Label

    Total White Brightening Body Cream diminishes the appearance of dark spots and skin discolorations caused by acne, aging, sun damage, and pregnancy.  This rich cream is formulated with Carrot Oil and Vitamins A and E, it effectively moisturizes and nourishes your skin, while it protects against future damage.  It safely brightens and evens dark spots for younger, healthier more radiant looking skin.

    Total White 1.75 oz Box

    Total White Brightening Body Cream With carrot oil Lightens SkinNatural Bio-Vegetal Activator  

    Total White 1,75 oz Creme Label
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  • INGREDIENTS AND APPEARANCE
    TOTAL WHITE BRIGHTENING  
    hydroquinone, ethylhexyl methoxycinnamate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53218-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (Octinoxate) Octinoxate 3 g  in 100 g
    Hydroquinone (Hydroquinone) Hydroquinone 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Coco-caprylate/caprate  
    Stearic Acid  
    Polyethylene Glycol 400  
    Cetyl Alcohol  
    Stearyl Stearate  
    Glyceryl Monostearate  
    Propylene Glycol  
    Kojic Acid  
    Carrot Seed Oil  
    Pentetic Acid  
    Corn Oil  
    Xanthan Gum  
    .alpha.-tocopherol Acetate  
    Vitamin A Palmitate  
    .beta.-carotene  
    Sodium Sulfite  
    Sodium Metabisulfite  
    Edetate Sodium  
    Methylparaben  
    Propylparaben  
    Dmdm Hydantoin  
    Polyethylene Glycol 4500  
    Sugarcane  
    Orange  
    Lemon  
    Bilberry  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53218-002-02 227 g in 1 JAR
    2 NDC:53218-002-03 454 g in 1 JAR
    3 NDC:53218-002-04 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/10/2012
    Labeler - YZY Inc (174375659)
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