HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS- octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone cream

Homme Aqua Sun Block SPF50 Plus PA 2Plus by

Drug Labeling and Warnings

Homme Aqua Sun Block SPF50 Plus PA 2Plus by is a Otc medication manufactured, distributed, or labeled by WIZCOZ CORPORATION LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose: Sunscreen

ACTIVE INGREDIENT

Active Ingredients: Octinoxate 7.50%, Octisalate 5.00%, Ensulizole 4.00%, Bemotrizinol 3.00%, Avobenzone 3.00%

WHEN USING

When using this product: Do not use other than directed

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

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

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

STORAGE AND HANDLING

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

DESCRIPTION

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 INGREDIENT

Inactive Ingredients: Chlorphenesin, Edetate Disodium, Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS 
octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49715-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.26 g  in 43.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.175 g  in 43.5 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.74 g  in 43.5 g
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH)	BEMOTRIZINOL	1.305 g  in 43.5 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.305 g  in 43.5 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49715-013-43	43.5 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2011

Labeler - WIZCOZ CORPORATION LTD (690397273)

Registrant - WIZCOZ CORPORATION LTD (690397273)

Establishment
Name	Address	ID/FEI	Business Operations
WIZCOZ CORPORATION LTD		690397273	manufacture