Label: BE AWESOME TODAY ALL THAT 20S BRILLIANT MASK- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 24, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Iron Powder, Carthamus Tinctorius (Safflower) Seed Oil, Caprylic/Capric Triglyceride, Vitis Vinifera (Grape) Seed Oil, Phenyl Trimethicone, Octyldodecanol, PEG-10 Dimethicone, Glyceryl Stearate, Bentonite, Oenothera Biennis (Evening Primrose) Oil, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, C30-45 Alkyldimethylsilyl Polypropylsilsesquioxane, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Olivate, Sorbitan Olivate, Sea Silt, Argania Spinosa Kernel Oil, Polyglyceryl-3 Polyricinoleate, Dibutyl Lauroyl Glutamide, Beeswax, Cyclomethicone, Dibutyl Ethylhexanoyl Glutamide, Pueraria Lobata Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Lactiflora Bark/Sap Extract, Poncirus Trifoliata Fruit Extract, Cnidium Officinale Root Extract, Kaolin, Chamomilla Recutita (Matricaria) Oil, Tocopheryl Acetate, Poly C10-30 Alkyl Acrylate, Titanium Dioxide, Cymbopogon Schoenanthus Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Oil, Sodium Hyaluronate, Phenoxyethanol, Echium Plantagineum Seed Oil, BHT, Adenosine, Helianthus Annuus (Sunflower) Seed Oil, Aluminum Hydroxide, Stearic Acid, Cardiospermum Halicacabum Flower/Leaf/Vine Extract

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. If you have the following symptoms while using this cosmetic product, you should stop using it. Please consult a dermatologist since using it continuously can worsen the symptoms. (1) While using it, you have symptoms like red spots, swelling, itching, irritation etc. (2) You have similar symptoms caused by direct sunlight on the applied area. 2. Do not use on areas with skin problems such as the wound, eczema and dermatitis. 3. Storage and Handling Precautions (1) Be sure to put the lid back on after use. (2) Keep this product out of the reach of infants and children. (3) Do not store this product in places with high/low temperatures and direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this product out of the reach of infants and children.

  • INDICATIONS & USAGE

    Indications & usage: 1. After face wash, put on some of the mask contents on the spatula. 2. Apply the mask evenly on the face except for the parts around the eyes and mouth. 3. Once finishing applying, wait for 10 minutes until the product is completely absorbed on the face. 4. Put on the plastic cover on the head of magnetic cleaner. 5. Slowly remove the mask by moving the magnetic cleaner on the face with 0.5 cm distance. (Remove the mud remains by changing the cover if necessary.) 6. After the mask is completely removed, touch the face with the hands to absorb the essence.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: It helps improve skin wrinkles. Take proper amount of the present product and spread evenly on the skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BE AWESOME TODAY ALL THAT 20S BRILLIANT MASK 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71060-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71060-010-021 in 1 CARTON10/10/2016
    1NDC:71060-010-0150 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/10/2016
    Labeler - ONA (689851847)
    Registrant - ONA (689851847)
    Establishment
    NameAddressID/FEIBusiness Operations
    ONA689851847manufacture(71060-010)