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Homme Aqua Sun Block SPF50 Plus PA 2Plus

Dosage form: cream
Ingredients: OCTINOXATE 3.26g in 43.5g, OCTISALATE 2.175g in 43.5g, ENSULIZOLE 1.74g in 43.5g, BEMOTRIZINOL 1.305g in 43.5g, AVOBENZONE 1.305g in 43.5g
Labeler: WIZCOZ CORPORATION LTD
NDC Code: 49715-013

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.

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.26 g  in 43.5 g
OCTISALATE (OCTISALATE) OCTISALATE2.175 g  in 43.5 g
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE1.74 g  in 43.5 g
BEMOTRIZINOL (BEMOTRIZINOL) BEMOTRIZINOL1.305 g  in 43.5 g
AVOBENZONE (AVOBENZONE) AVOBENZONE1.305 g  in 43.5 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN 
EDETATE DISODIUM 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
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/FEIOperations
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

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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