TOTAL WHITE BRIGHTENING - octinoxate and hydroquinone lotion 
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 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
TOTAL WHITE BRIGHTENING  
hydroquinone, ethylhexyl methoxycinnamate lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53218-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate14.19 mg  in 473 mL
Hydroquinone (Hydroquinone) Hydroquinone9.46 mg  in 473 mL
Inactive Ingredients
Ingredient NameStrength
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 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)

Revised: 6/2012
Document Id: f7d78925-b307-fd57-1b8c-128808d408c6
Set id: 89d9f2ec-5f73-e299-58b5-0a40d6fdc149
Version: 1
Effective Time: 20120607
 
YZY Inc