CLEMATIS FLUFFY MATTE CUSHION 21 LIGHT BEIGE- titanium dioxide, octinoxate, zinc oxide powder

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Coshub Co., Ltd.
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 0.98 g in 13 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
71702-020-01, 71702-020-02

CLEMATIS FLUFFY MATTE CUSHION 21 LIGHT 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.

----------

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, Boron Nitride, Lauryl PEG-9

Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Chloride, Iron Oxides (CI

77492), 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

CLEMATIS FLUFFY MATTE CUSHION 21 LIGHT BEIGE

titanium dioxide, octinoxate, zinc oxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7170 2-0 20

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium Dio xide (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

Titanium Dio xide

0 .9 8 g in 13 g

O ctino xa te (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

O c tino xa te

0 .9 1 g in 13 g

Zinc O xide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

0 .12 g in 13 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Coshub Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7170 2-0 20 -0 2

1 in 1 CARTON

0 8 /0 1/20 17

1

NDC:7170 2-0 20 -0 1

13 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 8 /0 1/20 17

Labeler -

Coshub Co., Ltd. (689846820)

Registrant -

Coshub Co., Ltd. (689846820)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EYESOME. Co .,Ltd.

55779 536 0

ma nufa c ture (7170 2-0 20 )

Revised: 9/2017

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