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Name:Bbcream
Manufacturer:E-house Korea Holdings International
Category:Over-the-counter (OTC) Marketed Drugs


BBCREAM  - titanium dioxide and octinoxate cream 
E-House Korea Holdings International

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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Directions: Apply on a clean, toned face

Active Ingredients: Titanium Dioxide 10.14%, Ethyhexyl Methoxycinnamate 4.5%

Uses: Apply prior to sun exposure.  Re-Apply as required

Purpose: Sunscreen

Inactive Ingredients: Water, Cyclopentasiloxane, Dimethicone, Talc, Arbutin, Dimethyl Sulfone, Aloe Barbedensis Leaf Juice, Silica

Caution: Do not apply to broken skin.  Avoid using on pimples and irritated skin.  Discontinue use if sun irritation develops or increases.
             If irritation persists, consult a health care practitioner.  Avoid contact with eyes

KEEP OUT OF REACH OF CHILDREN

Store in a cool dry place

Do not use other than directed.  For external use only

Sun alert warning: Sun may cause sunburn, premature aging of the skin and skin cancer.  Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects

Box Label

BBCREAM 
titanium dioxide, ethylhexyl methoxycinnamate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50387-300
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.04 mL  in 30 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.35 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
DIMETHICONE  
TALC  
CYCLOMETHICONE 5  
SQUALENE  
ARBUTIN  
POLYSORBATE 60  
LICORICE  
HYALURONATE SODIUM  
ALOE VERA LEAF  
SILICON DIOXIDE  
WHEAT  
ALUMINUM HYDROXIDE  
STEARIC ACID  
APRICOT  
EDETATE DISODIUM  
ADENOSINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50387-300-30 30 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/20/2011

Labeler - E-House Korea Holdings International (688527548)
Registrant - E-House Korea Holdings International (688527548)
Establishment
Name Address ID/FEI Operations
E-House Korea Holdings International 688527548 relabel
Establishment
Name Address ID/FEI Operations
Enbioscience Co Ltd 687650226 manufacture

Revised: 04/2011 E-House Korea Holdings International



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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