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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 28, 2019

If you are a consumer or patient please visit this version.

  • 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

    Image of carton

  • INGREDIENTS AND APPEARANCE
    GALAXYBORN SATIN CUSHION NO 21 
    titanium dioxide, octinoxate, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72256-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.70 g  in 15 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.45 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72256-010-021 in 1 CARTON03/01/2019
    1NDC:72256-010-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2019
    Labeler - DWAY CO LTD (694896351)
    Registrant - DWAY CO LTD (694896351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cit Co., Ltd.690081646manufacture(72256-010)