HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS - octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone 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: Octinoxate 7.50%, Octisalate 5.00%, Ensulizole 4.00%, Bemotrizinol 3.00%, Avobenzone 3.00%

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: Chlorphenesin, Edetate Disodium, Methylparaben, Propylparaben

Box Label
HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS 
octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49715-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.26 g  in 43.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.175 g  in 43.5 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.74 g  in 43.5 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.305 g  in 43.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.305 g  in 43.5 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49715-013-4343.5 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/01/2011
Labeler - WIZCOZ CORPORATION LTD (690397273)
Registrant - WIZCOZ CORPORATION LTD (690397273)
Establishment
NameAddressID/FEIBusiness Operations
WIZCOZ CORPORATION LTD690397273manufacture

Revised: 12/2011
Document Id: 9177a2ba-206e-4c0a-b5b0-3a164508f7e3
Set id: 5625e12e-3e3b-4268-a21a-c2800753f7e8
Version: 1
Effective Time: 20111201
 
WIZCOZ CORPORATION LTD