VILLAGE11FACTORY HYDRA SUN FLUID- octinoxate, homosalate, octisalate 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: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol, Alcohol,Methyl Methacrylate Crosspolymer,Niacinamide 1,2-Hexanediol,Polymethylsilsesquioxane, Salvia HispanicaSeed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Ethylhexylglycerin,Xanthan Gum, Octyldodecanol, Adenosine, EchiumPlantagineum Seed Oil, Butylene Glycol,Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) SeedOil Unsaponifiables, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, GlycerylStearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, TitaniumDioxide (CI 77891), C12-15 Alkyl Benzoate, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, CinnamomumCassia Bark Extract, Scutellaria Baicalensis Root Extract, Tocopherol,Moringa Pterygosperma Seed Extract, Polyglyceryl-2 Caprate,Aluminum Stearate, Polyhydroxystearic Acid, Alumina,Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol,Stearic Acid, Glyceryl Caprylate, 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 moist uv block sun fluid absorbs into your skin immediately without any stickiness. 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 HYDRA SUN FLUID 
octinoxate, homosalate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72470-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3.00 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72470-020-021 in 1 CARTON07/01/2018
1NDC:72470-020-0150 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(72470-020)

Revised: 8/2018
Document Id: d31b8b0c-7eb4-4af7-9c1f-35878487a574
Set id: 77671c32-f8c1-47be-8ebc-209a51962c3e
Version: 1
Effective Time: 20180807
 
PFD Co.,Ltd.