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

CLEMATIS Morning Dew CC by

Drug Labeling and Warnings

CLEMATIS Morning Dew CC by is a Otc medication manufactured, distributed, or labeled by Coshub Co., Ltd., COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71702-110
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
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.69 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.50 g  in 50 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.50 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71702-110-02	1 in 1 CARTON	08/01/2017
1	NDC: 71702-110-01	50 mL in 1 TUBE; 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	08/01/2017

Labeler - Coshub Co., Ltd. (689846820)

Registrant - Coshub Co., Ltd. (689846820)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(71702-110)