CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE- octinoxate, homosalate, octisalate gel 
Coshub 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 7.00%, Homosalate 6.00%, Ethylhexyl Salicylate 4.50%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Alcohol, Niacinamide, Polymethyl Methacrylate, Polymethylsilsesquioxane, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Phenoxyethanol, Fragrance, Fructooligosaccharides, Saccharide Hydrolysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Propanediol, Pullulan, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sambucus Nigra Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Magnolia Liliflora Flower Extract, Plumeria Rubra Flower Extract, Lilium Tigrinum Extract, Glyceryl Stearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, Titanium Dioxide (CI77891), C12-15 Alkyl Benzoate, Tocopherol, Polyglyceryl-2 Caprate, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol, Stearic Acid, Glyceryl Caprylate, Squalane

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

DESCRIPTION

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE 
octinoxate, homosalate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-060
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:71702-060-021 in 1 CARTON08/01/2017
1NDC:71702-060-0150 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 finalpart35208/01/2017
Labeler - Coshub Co., Ltd. (689846820)
Registrant - Coshub Co., Ltd. (689846820)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(71702-060)

Revised: 9/2017
Document Id: 8f3094f9-6b4a-4a21-8515-4de704d60a1c
Set id: 78b4a13f-5414-4186-8792-58ea0da39bc7
Version: 1
Effective Time: 20170905
 
Coshub Co., Ltd.