TOTAL WHITE BRIGHTENING - hydroquinone, ethylhexyl methoxycinnamate cream 
YZY Inc

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.

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Drug Facts

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 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
TOTAL WHITE BRIGHTENING  
hydroquinone, ethylhexyl methoxycinnamate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53218-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3 g  in 100 g
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone2 g  in 100 g
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:53218-002-02227 g in 1 JAR
2NDC:53218-002-03454 g in 1 JAR
3NDC:53218-002-0450 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/10/2012
Labeler - YZY Inc (174375659)

Revised: 6/2012
Document Id: a1adbdb7-d742-222d-dd33-1d274a198ec1
Set id: 52912284-80b3-c079-d02c-ea62cf164c3e
Version: 1
Effective Time: 20120607
 
YZY Inc