VILLAGE11FACTORY PINK CALMING SUN BLOCK- zinc oxide cream 
PFD Co.,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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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

Image of carton

VILLAGE11FACTORY PINK CALMING SUN BLOCK 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72470-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.00 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72470-030-021 in 1 CARTON07/01/2018
1NDC:72470-030-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2018
Labeler - PFD Co.,Ltd. (694522499)
Registrant - PFD Co.,Ltd. (694522499)
Establishment
NameAddressID/FEIBusiness Operations
Coson Co., Ltd._Osan Plant689847210manufacture(72470-030)

Revised: 8/2018
Document Id: 8dedd6ac-229e-4ac0-83a9-55b4f9b950a4
Set id: ffa11510-a1f1-4a8f-b751-4f4d90f39b7b
Version: 1
Effective Time: 20180807
 
PFD Co.,Ltd.