NDC 72256-010 Galaxyborn Satin Cushion No 21

Titanium Dioxide, Octinoxate, Octisalate

NDC Product Code 72256-010

NDC 72256-010-02

Package Description: 1 CONTAINER in 1 CARTON > 15 g in 1 CONTAINER (72256-010-01)

NDC Product Information

Galaxyborn Satin Cushion No 21 with NDC 72256-010 is a a human over the counter drug product labeled by Dway Co Ltd. The generic name of Galaxyborn Satin Cushion No 21 is titanium dioxide, octinoxate, octisalate. The product's dosage form is powder and is administered via topical form.

Labeler Name: Dway Co Ltd

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Galaxyborn Satin Cushion No 21 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TITANIUM DIOXIDE 1.7 g/15g
  • OCTINOXATE 1.05 g/15g
  • OCTISALATE .45 g/15g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dway Co Ltd
Labeler Code: 72256
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Galaxyborn Satin Cushion No 21 Product Label Images

Galaxyborn Satin Cushion No 21 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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: Sunscreen


Warnings:For external use only1) 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.


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.

* Please review the disclaimer below.