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

GALAXYBORN SATIN CUSHION NO 21 by

Drug Labeling and Warnings

GALAXYBORN SATIN CUSHION NO 21 by is a Otc medication manufactured, distributed, or labeled by DWAY CO LTD, Cit Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72256-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.70 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.05 g  in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.45 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72256-010-02	1 in 1 CARTON	03/01/2019
1	NDC: 72256-010-01	15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2019

Labeler - DWAY CO LTD (694896351)

Registrant - DWAY CO LTD (694896351)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	manufacture(72256-010)