Label: ESMIA AIR CUSHION LIGHT BEIGE 21- titanium dioxide, octinoxate, zinc oxide 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 October 19, 2018

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

  • Active Ingredients 

    Active ingredients: Titanium Dioxide 9.98%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water,Cyclopentasiloxane, Glycerin,Phenyl Trimethicone,Butylene Glycol Dicaprylate/Dicaprate
    Butylene Glycol,PEG-10 Dimethicone,Caprylyl Methicone,Pentylene Glycol,Niacinamide,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,Ethylhexyl Palmitate
    Trimethylsiloxysilicate,Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate,Boron Nitride,Diphenyl Dimethicone,
    Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer,Phytosteryl Isostearyl Dimer Dilinoleate,Biosaccharide Gum-1,Decyl Glucoside
    Aluminum Hydroxide,Phenoxyethanol,Methyl Methacrylate Crosspolymer,Disteardimonium Hectorite,Triethoxycaprylylsilane,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
    Tocopheryl Acetate,Silica Dimethyl Silylate,Ethylhexylglycerin,Allantoin,HDI/Trimethylol Hexyllactone Crosspolymer,Dimethicone/Vinyl Dimethicone Crosspolymer,Adenosine
    Disodium EDTA,Propylene Glycol,Xanthan Gum,Pseudoalteromonas Ferment Extract,Aloe Barbadensis Leaf Juice Powder,Silica,Hydrolyzed Extensin,Althaea Rosea Flower Extract
    Aloe Barbadensis Leaf Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Argania Spinosa Kernel Oil,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499)
    Fragrance,Leontopodium Alpinum Extract,Citric Acid,Sodium Benzoate ,Potassium Sorbate

  • Purpose

    Purpose: Sunscreen

  • Warnings

    Warnings:

    FOR EXTERNAL USE ONLY

    - Do not use on damaged or broken skin

    - When using this product, Keep out of eyes. Rinse with water to remove.

    - Stop use and ask a doctor if rash occurs.

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

  • DESCRIPTION

    Uses:

    Helps prevent sunburn

    Directions:

    Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

    Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ESMIA AIR CUSHION LIGHT BEIGE 21 
    titanium dioxide, octinoxate, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72600-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.49 g  in 15 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.80 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72600-190-021 in 1 CARTON09/01/2018
    1NDC:72600-190-0115 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 finalpart35209/01/2018
    Labeler - Bs Cosmetics Co.,ltd. (694791429)
    Registrant - Bs Cosmetics Co.,ltd. (694791429)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(72600-190)