VILLAGE11FACTORY WATERPROOF CICA SUN- octinoxate, homosalate, octisalate lotion

Village11Factory Waterproof Cica Sun by

Drug Labeling and Warnings

Village11Factory Waterproof Cica Sun 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 INGREDIENTS

Ethylhexyl Methoxycinnamate 6.0%
Homosalate 5.0%
Ethylhexyl Salicylate 4.0%

INACTIVE INGREDIENTS

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Propanediol, 1,2-Hexanediol, Dimethicone Crosspolymer, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Pentylene Glycol, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Triethanolamine, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Octyldodecanol, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Tocopherol, Anthemis Nobilis Flower Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Persea Gratissima (Avocado) Fruit Extract, Xanthan Gum, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, t-Butyl Alcohol, C12-15 Alkyl Benzoate, Titanium Dioxide (CI 77891), Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Oleth-10, Isodeceth-6, Simethicone, Dimethicone

PURPOSE

Sunscreen

WARNINGS

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Do not apply on broken skin or wounded areas.
Keep out of reach of children
Store away from direct sunlight.

DESCRIPTION

Uses:

■ Helps prevent sun burn. Waterproof Sun Lotion that moisturizes the skin and prevents sun burn even when in contact with sweat, water, and sebum.

Directions:

■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
■ Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VILLAGE11FACTORY WATERPROOF CICA SUN 
octinoxate, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72470-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	6.0 g  in 80 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	4.0 g  in 80 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	3.2 g  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propanediol (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72470-040-02	1 in 1 CARTON	11/20/2020
1	NDC: 72470-040-01	80 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	11/20/2020

Labeler - PFD Co.,Ltd. (694522499)

Registrant - PFD Co.,Ltd. (694522499)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(72470-040)