CLEMATIS FLUFFY MATTE CUSHION 25 SOFT BEIGE- titanium dioxide, octinoxate, zinc oxide powder 
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: Titanium Dioxide 7.60%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dimethicone, PEG-10 Dimethicone, Cetyl Ethylhexanoate, Cyclohexasiloxane, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Diisostearyl Malate, Niacinamide, Polypropylsilsesquioxane, Iron Oxides (CI 77492), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Glycerin, Boron Nitride, Sodium Chloride, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Disteardimonium Hectorite, Iron Oxides (CI 77491), Decyl Glucoside , Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77499), Polysilicone-11 ,Glyceryl Acrylate/Acrylic Acid Copolymer, Ethylhexylglycerin, Adenosine, Propylene Glycol, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Allantoin, Fragrance

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only. Avoid contact with eyes. 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: Gently press the pull on the air cushion and pat it onto your skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLEMATIS FLUFFY MATTE CUSHION 25 SOFT BEIGE 
titanium dioxide, octinoxate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.98 g  in 13 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.91 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.12 g  in 13 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71702-040-021 in 1 CARTON08/01/2017
1NDC:71702-040-0113 g 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
EYESOME. Co.,Ltd.557795360manufacture(71702-040)

Revised: 9/2017
Document Id: e5ab19c9-1ea3-42df-9926-73f17eebd5fe
Set id: 9bed3bf1-2f88-4856-baf8-4afe9882f3ea
Version: 1
Effective Time: 20170905
 
Coshub Co., Ltd.