Label: CLEMATIS MORNING DEW CC- octinoxate, titanium dioxide, octisalate, homosalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71702-110-01, 71702-110-02 - Packager: Coshub 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 September 5, 2017
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- ACTIVE INGREDIENT
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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
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEMATIS MORNING DEW CC
octinoxate, titanium dioxide, octisalate, homosalate creamProduct 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)
