SUPERPLUS BEBLESH BALM SPF25 PA 2PLUS - titanium dioxide, octinoxate, octisalate, arbutin, zinc oxide, adenosine cream 
WIZCOZ CORPORATION 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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Purpose: Sunscreen

Active Ingredients: Titanium Dioxide 4.81%, Octinoxate 3.00%, Octisalate 2.00%, Arbutin 2.00%, Zinc Oxide 1.95%, Adenosine 0.04%

When using this product: Do not use other than directed

Do Not Use: On wounds, rashes, dermatitis or damaged skin

Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately

Stop Use: Please stop using this product and contact a dermatologist.
                1. If red rash, swelling, itch or irritation occurs
                2. If direct sunlight affects the area as above

Warnings: For external use only.  Do not use other than directed.  Keep the lid back on after using

Storage: Keep in a cool, dry place away from heat and direct sunlight

Direction:  
Step 1: Clean and dry your face
Step 2: Use the basic skincare products
Step 3: Use small amount of it and apply evenly and thoroughly to your face
                

Inactive Ingredients: Aluminum Hydroxide, Aluminum Stearate, BHT, Butylparaben, Methylparaben, Iron Oxide, Phenoxyethanol, Propylparaben

Box Label
SUPERPLUS BEBLESH BALM SPF25 PA 2PLUS 
titanium dioxide, octinoxate, octisalate, arbutin, zinc oxide, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49715-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.92 g  in 40 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.78 g  in 40 g
ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN0.8 g  in 40 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.016 g  in 40 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.2 g  in 40 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.8 g  in 40 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49715-018-4040 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2012
Labeler - WIZCOZ CORPORATION LTD (690397273)
Registrant - WIZCOZ CORPORATION LTD (690397273)
Establishment
NameAddressID/FEIBusiness Operations
WIZCOZ CORPORATION LTD690397273manufacture

Revised: 2/2012
Document Id: 17643708-053c-4aed-a3da-0abbf1d6e06d
Set id: 7eee940a-96c6-4d37-9991-fa84b1b4f02b
Version: 1
Effective Time: 20120201
 
WIZCOZ CORPORATION LTD