Label: DR FROG TOCOVITA ENERGY- 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 April 13, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    WATER,BUTYLENE GLYCOL,GLYCERIN,HYDROGENATED POLYDECENE,CETEARYL ALCOHOL,1,2-HEXANEDIOL,MACADAMIA INTEGRIFOLIA SEED OIL,GLYCERYL STEARATE,ETHLY ASCORBYL ETHER,CETEARETH-12,DIETHYLHEXYL CARBONATE,PROPYLHEPTYL CAPRYLATE,OXIDIZED CORN OIL,PHYTOSTERYL/DECYLTETRADECYL MYRISTOYL METHYL BETA-ALANINATE,CETEARYL OLIVATE,BEESWAX,SORBITAN OLIVATE,PEG-100 STEARATE,GLYCERYL CAPRYLATE,POLYACRYLATE-13,SUCROSE POLYSTEARATE,FRAGRANCE,TOCOPHERYL ACETATE,ARGININE,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,NIACINAMIDE,POLYISOBUTENE,SQUALANE,GLYCERETH-26,XANTHAN GUM,HYDROGENATED POLYISOBUTENE,BETAINE,(-)-ALPHA-BISABOLOL,HYDROLYZED LUPINE PROTEIN,BIOSACCHARIDE GUM-1,ETHOXYDIGLYCOL,ULMUS DAVIDIANA ROOT EXTRACT,BIFIDA FERMENT LYSATE,LACTOBACILLUS/BAMBUSA VULGARIS SHOOT EXTRACT/GLYCYRRHIZA GLABRA ROOT EXTRACT/LUFFA CYLINDRICA FRUIT EXTRACT/MORUS ALBA ROOT EXTRACT/PUERARIA LOBATA ROOT EXTRACT FERMENT FILTRATE ,CENTELLA ASIATICA EXTRACT,SODIUM HYALURONATE,HIPPOPHAE RHAMNOIDES FRUIT EXTRACT,ALCOHOL,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,SODIUM COCOYL ALANINATE,ETHYLHEXYL PALMITATE,DIOSPYROS KAKI LEAF EXTRACT,POLYSORBATE 20,ZIYU GLYCOSIDE I,SORBITAN ISOSTEARATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,RAFFINOSE,MORUS ALBA ROOT EXTRACT,DISODIUM EDTA,DIPOTASSIUM GLYCYRRHIZATE,HYDROLYZED HYALURONIC ACID,VITIS VINIFERA (GRAPE) CALLUS CULTURE EXTRACT,POLYSORBATE 60,HIPPOPHAE RHAMNOIDES EXTRACT,ASCORBYL TOCOPHERYL ACETATE,GARDENIA FLORIDA FRUIT EXTRACT,GLYCERYL POLYACRYLATE,HYDROGENATED LECITHIN,SUCROSE PALMITATE,DEXTRIN,CYCLOMETHICONE,HYDROLYZED JOJOBA ESTERS,POLYSORBATE 80,SILICA DIMETHYL SILYLATE,BACILLUS/SOYBEAN FERMENT EXTRACT,TOTAROL,PAEONIA SUFFRUTICOSA ROOT EXTRACT,CAPRYLYL GLYCOL,PALMITOYL TRIPEPTIDE-1,BRASSICA CAMPESTRIS (RAPESEED) STEROLS,PEG-5 RAPESEED STEROL,ASCOPHYLLUM NODOSUM EXTRACT,CRINUM ASIATICUM EXTRACT,PALMITOYL TETRAPEPTIDE-7,PHYTOSPHINGOSINE ASCORBATE,CETETH-3,CETETH-5,CHOLESTEROL,GLYCINE,GLUTAMINE,ASPARAGINE,TROPOLONE

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1) Please stop using the product if the following symptoms occur or appear when the skin is exposed to direct sunlight: red blotches, swelling, itchiness or other irritations while using product. Then, consult a dermatologist or a specialist.

    2) Please do not apply the product on wound or any of skin irritation, such as eczema or dermatitis.

    3) Precaution during storage/handling. a) Keep the product closed after using b) Keep out of reach of children c) Avoid storing in high and low temperature and areas exposed to direct sunlight

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    [Anti-wrinkle, Brightening]

    Total care firming cream with 7 patented ingredients that provides rich nutrition to skin.

    1. Maximize the absorption of active ingredients Enriched cream texture provides rich nutrition and helps absorb active ingredients into skin.

    2. Provides resilient energy to skin Seven patented ingredients including Tocovita-C maximize clean and resilient energy in skin. 3. Relieve skin stress Totarol ingredients from totarol tree, which lives for over a thousand years, relieve stress and provide vitality to skin

  • Directions

    Directions:

    Apply an appropriate amount and spread all over the face, accordingly following the skin texture softly in the morning∙evening cream steps.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR FROG TOCOVITA ENERGY 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22201-1020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22201-1020-21 in 1 CARTON03/01/2018
    1NDC:22201-1020-150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Labeler - Charmzone Co Ltd (689049765)
    Registrant - Charmzone Co Ltd (689049765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charmzone Co., Ltd._Wonju Factory688238394manufacture(22201-1020)