CLEMATIS BASE CUSHION- octinoxate, titanium dioxide, octisalate, 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: Ethylhexyl Methoxycinnamate 7.50%, Titanium Dioxide 6.05%, Ethylhexyl Salicylate 5.00%, Zinc Oxide 1.96%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Glycerin, Niacinamide, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,PEG-10 Dimethicone, Aluminum Hydroxide, Magnesium Sulfate, Stearic Acid, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Polyhydroxystearic Acid , Caprylyl Glycol, Methyl Methacrylate Crosspolymer, Allantoin, Tocopheryl Acetate, Lecithin, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Myristate, Iron Oxides (CI 77491), Caprylhydroxamic Acid, Triethoxycaprylylsilane, Adenosine, Polyglyceryl-3 Polyricinoleate, Disodium EDTA, Aloe Barbadensis Leaf Juice Powder, Biosaccharide Gum-1, Sophora Japonica Fruit Extract, Pancratium Maritimum Extract, 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 BASE CUSHION 
octinoxate, titanium dioxide, octisalate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71702-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.97 g  in 13 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.78 g  in 13 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.65 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.25 g  in 13 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71702-010-021 in 1 CARTON08/01/2017
1NDC:71702-010-0113 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(71702-010)

Revised: 9/2017
Document Id: 135597f2-0b90-45af-9a4a-fee4d371837c
Set id: 686d0611-18e8-4905-a42b-4887127a5091
Version: 1
Effective Time: 20170904
 
Coshub Co., Ltd.