IT RADIANT CC CUSHION BE10- titanium dioxide, octinoxate, octisalate cream

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), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
F&CO Co., Ltd.
INN (International Name):
TITANIUM DIOXIDE
Composition:
TITANIUM DIOXIDE 1.07 g in 15 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen How to Use: Use enclosed sponge to apply the product for light touch-ups or the entire face evenly.
Authorization status:
OTC monograph not final
Authorization number:
69106-040-01

IT RADIANT CC CUSHION BE10- titanium dioxide, octinoxate, octisalate cream

F&CO 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 7.16%, Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate

3.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, Cyclopentasiloxane, Glycerin, Dimethicone, Cyclohexasiloxane, Pentylene

Glycol, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Mica (CI 77019), Dicaprylyl Carbonate,

Phenyl Tirmethicone, PEG-10 Dimethicone, Triceteareth-4 Phosphate, Glycol Stearate,

Phenoxyethanol, Glyceryl Stearate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica,

Potassium Cetyl Phosphate, Polysorbate 60, PEG-2 Stearate, PEG-100 Stearate, Iron Oxides (CI

77492), Triethoxycaprylylsilane, Aluminum Hydroxide, Carbomer, Iron Oxides (CI 77491), Sodium

Acrylate/Sodium Acryloyldimethicone Taurate Copolymer, Tromethamine, Fragrance(Parfum),

Ethylhexylglycerin, Isohexadecane, Adenosine, Iron Oxides (CI 77499), Polysorbate 80, Disodium

EDTA, Tremella Fuciformis (Mushroom) Extract, Saccharide Isomerate, Imperata Cylindrica Root

Extract, Nelumbo Nucifera Flower Extract, Prunus Serrulata Flower Extract, Nymphaea Alba Flower

Extract, Rosa Hybrid Flower Extract, Iris Versicolor Extract, Lilium Candidum Bulb Extract,

Leontopodium Alpinum Flower/Leaf Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf

Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, PEG-8, Ethyl

Hexanediol, Maltodextrin, Xanthan Gum, Orthosiphon Stamineus Leaf Extract, Sodium Citrate, Citric

Acid, Potassium Sorbate, Phospholipids, Whey Protein, Lactose, Sodium Dehydroacetate

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION:

If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin.

For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat

or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

How to Use

How to Use: Use enclosed sponge to apply the product for light touch-ups or the entire face evenly.

Dosage & Administration

Dosage & Administration:

This moisture recharging CC Cushion is formulated with 55% water base helps complete a flawless,

luminous complexion and ensures color builds into fine, even layers with a refreshing finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT CC CUSHION BE10

titanium dioxide, octinoxate, octisalate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 10 6 -0 40

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

1.0 7 g in 15 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

1.0 5 g in 15 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

0 .45 g in 15 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

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

F&CO Co., Ltd.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 10 6 -0 40 -0 1

15 g in 1 CARTON

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 7/0 1/20 14

Labeler -

F&CO Co., Ltd. (690166186)

Registrant -

F&CO Co., Ltd. (690166186)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

F&CO Co ., Ltd.

6 9 0 16 6 18 6

ma nufa c ture (6 9 10 6 -0 40 )

Revised: 8/2014

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