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Name:Age-x Platinum Bb
Manufacturer:Have And Be Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

AGE-X PLATINUM BB  - titanium dioxide and octinoxate cream 
Have and Be Co., Ltd.

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

Titanium Dioxde 5.6%

Octinoxate 7%


Stop use and ask a doctor if

    * rash or irritation develops and lasts

Keep out of reach of children

    * if swallowed get medical help or contact a poison control center right away.

When using this product

    * keep out of eyes. Rinse with water to remove

Purpose

Sunscreen

image of AGE BB labelEnter section text here


AGE-X PLATINUM BB 
titanium dioxide, octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-104
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
titanium dioxide (Titanium Dioxide) titanium dioxide 1.680 mL  in 30 mL
octinoxate (octinoxate) octinoxate 2.1 mL  in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Dipropylene Glycol  
CYCLOMETHICONE 5  
DIMETHICONE  
Hexyl Laurate  
AMILOXATE  
Arbutin  
MAGNESIUM SULFATE, UNSPECIFIED  
Sorbitan Sesquioleate  
Talc  
BEMOTRIZINOL  
YELLOW WAX  
LOWBUSH BLUEBERRY  
IRON  
Phenoxyethanol  
HECTORITE  
Methylparaben  
Panthenol  
GREEN TEA LEAF  
Glycerin  
MEDIUM-CHAIN TRIGLYCERIDES  
HYDROGENATED SOYBEAN LECITHIN  
Cholesterol  
FRUIT  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
PROPYLPARABEN  
ETHYLPARABEN  
ADENOSINE  
LEVOMENOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49404-104-02 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (49404-104-01)
1 NDC:49404-104-01 30 mL in 1 TUBE This package is contained within the CARTON (49404-104-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2010

Labeler - Have and Be Co., Ltd. (690400408)
Registrant - Kodent Inc. (172903218)
Establishment
Name Address ID/FEI Operations
Have and Be Co., Ltd. 690400408 manufacture

Revised: 11/2010 Have and Be Co., Ltd.



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


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