GALAXYBORN SATIN CUSHION NO 21- 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), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
DWAY CO LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
72256-010-01, 72256-010-02

GALAXYBORN SATIN CUSHION NO 21- titanium dioxide, octinoxate, octisalate powder

DWAY 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 11.38%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl

Salicylate 3.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone,

Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide,

Dicaprylyl Carbonate, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine,

Trimethylsiloxysilicate, Sodium Chloride, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Lauryl PEG-

9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Beeswax, Disteardimonium Hectorite,

Polypropylsilsesquioxane, Isododecane, Dimethicone, Iron Oxides (CI 77491), Dipropylene Glycol,

Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Chlorphenesin, Trihydroxystearin, 1,2-

Hexanediol, Hydroxyacetophenone, Saccharum Officinarum (Sugar Cane) Extract, Sodium Hyaluronate,

Mentha Rotundifolia Leaf Extract, Propylene Carbonate, Iron Oxides (CI 77499), Fragrance(Parfum),

Dimethiconol, Adenosine, Triethoxycaprylylsilane, Disodium EDTA, Brassica Campestris (Rapeseed)

Flower Extract, Narcissus Tazetta Extract, Calendula Officinalis Flower Extract, Freesia Alba Flower

Extract, Taraxacum Officinale (Dandelion) Extract, Helianthus Annuus (Sunflower) Flower Extract,

Oxalis Hedysaroides Extract, Papaver Rhoeas Flower Extract, Glycerin, Tocopherol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

1) It is recommend to stop using the product and talk to dermatologist immediately if you are suffering

such conditions : rash, swell up, itchiness.

2) Do not apply this product on any skin trouble.

3) Caution for storage and handling; always recap after use. Keep this product out of the reach of

children. Avoid extremely high and low temperature and direct sunlight.

4) For the cleanliness in using the product, do not share the puff with someone else and it is

recommended to keep it clean.

DESCRIPTION

Uses:

Helps prevent sunburn.

Directions:

1) Use at the sunscreen step after your basic skin care routine (it works as a sunblock, makeup base, and

foundation) or Make-up before and after can be used.

2) Using the puff applicator, press down on the cushion sponge to get the foundation on the puff.

3) Close the inner lid tightly after each use to preserve freshness. Not closing the lid may cause the

beneficial ingredients to evaporate and make the cushion sponge to shrink.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GALAXYBORN SATIN CUSHION NO 21

titanium dioxide, octinoxate, octisalate powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72256 -0 10

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

1.70 g in 15 g

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

O c tino xa te

1.0 5 g in 15 g

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

O c tisa la te

0 .45 g in 15 g

DWAY CO LTD

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72256 -0 10 -0 2

1 in 1 CARTON

0 3/0 1/20 19

1

NDC:72256 -0 10 -0 1

15 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 3/0 1/20 19

Labeler -

DWAY CO LT D (694896351)

Registrant -

DWAY CO LT D (694896351)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cit Co ., Ltd.

6 9 0 0 8 16 46

ma nufa c ture (72256 -0 10 )

Revised: 3/2019

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