CLEMATIS MORNING DEW CC- octinoxate, titanium dioxide, octisalate, homosalate cream 
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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 3.39%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Butylene Glycol, Cyclopentasiloxane, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Mica (CI 77019), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone, Ethylhexyl Triazone, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Isohexadecane, Polysorbate 80, PEG-2 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Cetyl Phosphate, Biosaccharide Gum-1, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Aluminum Hydroxide, PEG-10 Dimethicone, Stearic Acid, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Allantoin, Adenosine, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Pancratium Maritimum Extract, Glycerin, Alcohol, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Iron Oxides (CI 77492), Iron Oxides (CI 77491),Fragrance

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 MORNING DEW CC 
octinoxate, titanium dioxide, octisalate, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.69 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.50 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.50 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71702-110-021 in 1 CARTON08/01/2017
1NDC:71702-110-0150 mL in 1 TUBE; 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(71702-110)

Revised: 9/2017
Document Id: 9d2c27ed-d394-4764-86fd-a3d2293a68e8
Set id: 655d52ed-976c-4f22-94c4-667a188012b2
Version: 1
Effective Time: 20170905
 
Coshub Co., Ltd.