Rejuvenating BB

Dosage form: cream
Ingredients: Titanium Dioxide 4.5mL in 50mL, octinoxate 2mL in 50mL
Labeler: Have and Be Co., Ltd.
NDC Code: 49404-103

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 Facts

Active Ingredients

Titanium Dioxde 9%

Octinoxate 4%


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

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REJUVENATING BB 
titanium dioxde, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (titanium dioxide) Titanium Dioxide4.5 mL  in 50 mL
octinoxate (octinoxate) octinoxate2 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
water 
CYCLOMETHICONE 5 
Butylene Glycol 
Dimethicone 
ENZACAMENE 
SILICON DIOXIDE 
Glycerin 
PHENYL TRIMETHICONE 
CYCLOMETHICONE 6 
Sodium Chloride 
Arbutin 
Sorbitan Olivate 
Hexyl Laurate 
HECTORITE  
Propylene Carbonate 
YELLOW WAX 
SORBITAN 
BUTYLENE GLYCOL 
Polyglyceryl-4 Isostearate 
.ALPHA.-TOCOPHEROL ACETATE, DL-  
Calcium Stearate 
QUATERNIUM-18 
Methylparaben 
Butylparaben 
Propylparaben 
Chlorphenesin 
HYALURONATE SODIUM 
CENTELLA ASIATICA 
Panthenol 
Caffeine 
EDETATE DISODIUM  
Mica 
UBIDECARENONE 
Packaging
#Item CodePackage Description
1NDC:49404-103-021 TUBE (TUBE) in 1 CARTON
1NDC:49404-103-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
Labeler - Have and Be Co., Ltd. (690400408)
Registrant - Kodent Inc. (172903218)
Establishment
NameAddressID/FEIOperations
Have and Be Co., Ltd.690400408manufacture

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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