NOTS CRYSTAL CC CUSHION NO 23 titanium dioxide octinoxate octisalate powder

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

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
NoTS Co.,Ltd
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 1.96 g in 14 g
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

NOTS CRYSTAL CC CUSHION NO 23- titanium dioxide, octinoxate, octisalate powder

NoTS 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 Ingredient: Titanium Dioxide 14.0%, Ethylhexyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate

5.0%

INACTIVE INGREDIENT

Inactive Ingredients:

Rosa Centifolia Flower Water, Phenyl Trimethicone, Glycerin, C12-15 Alkyl Benzoate, Lauryl PEG-9

Polydimethylsiloxyethyl Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl

Ethylhexanoate, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Niacinamide, Sorbitan Sesquioleate,

Cyclohexasiloxane, Dimethicone, CI 77492, Silica, Aluminum Stearate, Polyhydroxystearic Acid,

Alumina, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, CI 77499, CI 77491,

Salicornia Herbacea Extract, Phragmites Communis Extract, Lavandula Angustifolia (Lavender) Water,

Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract, Centaurea cyanus flower Extract, Borago

officinalis Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Acetyl Hexapeptide-22,

Caffeoyl Tripeptide-1, sh-Octapeptide-4, sh-Decapeptide-7, sh-Pentapeptide-19, Oligopeptide-28,

Adenosine, Sodium Chloride, Aluminum Hydroxide, Triethoxycaprylylsilane, Caprylhydroxamic Acid ,

1,2-Hexanediol, Butylene Glycol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

Stop use and ask dermatologist or doctor if

signs of redness, skin swelling, itchy spots, irritation or rash and other appear

the above signs appear in the applied area by direct rays of the sun

Do not use over

wounds rashes inflammations other troubled areas.

Do not stay too long in the sun, even while using a sunscreen product.

When using

Avoid the eye area

must close the cap after using

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

DESCRIPTION

Uses: UV-Ray protection

Directions: Squeeze the puff onto the cushion. Using puff pat lightly and evenly over face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOTS CRYSTAL CC CUSHION NO 23

titanium dioxide, octinoxate, octisalate powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 716 -270

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

1.9 6 g in 14 g

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

O c tino xa te

1.0 5 g in 14 g

O ctisa la te (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

O c tisa la te

0 .70 g in 14 g

Inactive Ingredients

Ingredient Name

Stre ng th

RO SA CENTIFO LIA FLO WER O IL (UNII: H32V31VMWY)

Phenyl Trimethico ne (UNII: DR0 K5NOJ4R)

Packag ing

NoTS Co.,Ltd

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 716 -270 -

1 in 1 CARTON

12/0 1/20 16

1

NDC:6 9 716 -270 -

14 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

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

12/0 1/20 16

Labeler -

NoT S Co.,Ltd (689004599)

Registrant -

NoT S Co.,Ltd (689004599)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Natuzen Co .,Ltd.

6 8 8 20 1272

ma nufa c ture (6 9 716 -270 )

Revised: 1/2018

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