VILLAGE11FACTORY PINK CALMING SUN BLOCK- zinc oxide cream

VILLAGE11FACTORY PINK CALMING SUN BLOCK by

Drug Labeling and Warnings

VILLAGE11FACTORY PINK CALMING SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by PFD Co.,Ltd., Coson Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Zinc Oxide 12%

INACTIVE INGREDIENT

Inactive ingredients:

Water,Cyclopentasiloxane,Dimethicone,Propanediol,Titanium Dioxide (CI 77891),Phenyl Trimethicone, Calamine, PEG-10Dimethicone, Niacinamide,1,2-Hexanediol, Disteardimonium Hectorite,Magnesium Sulfate,Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrogen Dimethicone, Aluminum Hydroxide, Cetearyl Dimethicone Crosspolymer, Stearic Acid, Sorbitan Sesquioleate, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Ethylhexylglycerin, Octyldodecanol,Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil,Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract,Cardiospermum Halicacabum Flower/ Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Polyglyceryl-2Dipolyhydroxystearate, Cyclomethicone, C12-15 Alkyl Benzoate, Tocopherol, Dimethicone Crosspolymer, Polyglyceryl-2 Caprate,Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, GlycerylCaprylate, Squalane, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

1) In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

2) Do not apply on broken skin or wounded areas.

3) Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight.

4) For external use only

DESCRIPTION

Uses:

Containing the UV suncare secret of Village 11 factory, this calming tone up sun block protects the skin from UV rays and external harm. Also, it helps to prevent sunburn.

Directions:

For the last step of your skin care, apply an appropriate amount onto areas of your skin that is exposed to sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VILLAGE11FACTORY PINK CALMING SUN BLOCK 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72470-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.00 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72470-030-02	1 in 1 CARTON	07/01/2018
1	NDC: 72470-030-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2018

Labeler - PFD Co.,Ltd. (694522499)

Registrant - PFD Co.,Ltd. (694522499)

Establishment
Name	Address	ID/FEI	Business Operations
Coson Co., Ltd._Osan Plant		689847210	manufacture(72470-030)