Label: VILLAGE11FACTORY HYDRA SUN FLUID- octinoxate, homosalate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72470-020-01, 72470-020-02 - Packager: PFD Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 7, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
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INGREDIENTS AND APPEARANCE
VILLAGE11FACTORY HYDRA SUN FLUID
octinoxate, homosalate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72470-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 3.50 g in 50 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 3.00 g in 50 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.25 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72470-020-02 1 in 1 CARTON 07/01/2018 1 NDC:72470-020-01 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(72470-020)
