Label: TOTAL WHITE BRIGHTENING- hydroquinone, ethylhexyl methoxycinnamate lotion

  • 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 June 7, 2012

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  • Active Ingredients

    Hydroquinone 2%
    Ethylhexyl Methoxycinnamate 3%

  • Purpose

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

  • Uses:

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

  • Warnings:

    For external use only

  • Do Not Use

    To prevent sunburn • On inflamed or broken skin

  • 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

  • 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

  • If pregnant or breast feeding,

    consult a health professional before use.

  • Keep out of reach of children.

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

  • 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.

  • 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)

  • PRINCIPAL DISPLAY PANEL

    Total White
    Brightening Body Lotion
    Lightens Skin
    Natural Bio-vegetal Activation
    With Carrot Oil
    16 FL. OZ e 473 mL
    Distributed by Heaven Scent, Miami FL
    shimonb@yzyinc.com 877-999-3534
    Tottenham, London N17 OQT, UK
    MADE IN USA 

    Total White Brightening Body Lotion diminshes dark spots and skin discolorations caused by acne, aging, sun damage, and pregnancy. This special formula is fortified with Carrot Oil and Vitamins A and E to help restore and maintain skin's essentialmoisture balance leaving your skin feeling beautifully softand smooth. This light, fast absorbing lotion safely fades and evens complexion for younger and healthier looking skin.

    Total White Label
  • INGREDIENTS AND APPEARANCE
    TOTAL WHITE BRIGHTENING  
    hydroquinone, ethylhexyl methoxycinnamate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53218-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate14.19 mg  in 473 mL
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone9.46 mg  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Coco-caprylate/caprate (UNII: 8D9H4QU99H)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Stearate (UNII: 5WX2EGD0DK)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Kojic Acid (UNII: 6K23F1TT52)  
    Carrot Seed Oil (UNII: 595AO13F11)  
    Pentetic Acid (UNII: 7A314HQM0I)  
    Corn Oil (UNII: 8470G57WFM)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    .beta.-carotene (UNII: 01YAE03M7J)  
    Sodium Sulfite (UNII: VTK01UQK3G)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Dmdm Hydantoin (UNII: BYR0546TOW)  
    Polyethylene Glycol 4500 (UNII: TVH7653921)  
    Sugarcane (UNII: 81H2R5AOH3)  
    Orange (UNII: 5EVU04N5QU)  
    Lemon (UNII: 24RS0A988O)  
    Bilberry (UNII: 9P2U39H18W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53218-001-01473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/10/2012
    Labeler - YZY Inc (174375659)
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