Label: TONYMOLY FACE MIX SKIN MAKEUP BASE 02 MIX LAVENDAR SPF20- titanium dioxide lotion

  • 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 February 1, 2016

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

  • Active Ingredients

    Dimethicone 1.00%, Ethylhexyl Methoxycinnamate 4.00%, Glycerin 2.00%, Titanium Dioxide 9.45%, Zinc Oxide 1.00%

  • Purpose

    Skin Protectant

  • Use

    SPF20 PA++

    4-in-1 makeip base for healthy skin tone and clean and balanced skin.

  • Caution

    For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

  • Keep out of reach of children

    Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

  • Directions

    After using our basic skin care products, apply an appropriate amount evenly to the face and gently pat to have an smooth finish.

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Nelumbo Nucifera Flower Water, Cyclohexasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclomethicone, PEG10 Dimethicone, Dicaprylyl Carbonate, Hexyldecyl Myristoyl Methylaminopropionate, Maltitol, Disteardimonium Hectorite, Ultramarines (CI 77007), Magnesium Sulfate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Cetyl PEG/PPG10/1 Dimethicone, Ceresin, Fragrance(Parfum), Triethoxycaprylylsilane, Methyl Methacrylate Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Disodium EDTA, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydrolyzed Collagen, Ceramide 3, Sodium Hyaluronate, Ascorbic Acid, Butylene Glycol, Polysilicone11, Aspalathus Linearis Extract, Lilium Candidum Flower Extract, Borago Officinalis Extract, Salvia Officinalis (Sage) Leaf Extract, Centaurea Cyanus Flower Extract, Anthemis Nobilis Flower Extract, Trimethylsiloxysilicate, Copernicia Cerifera (Carnauba) Wax

  • Principal Display Panel

    product

  • INGREDIENTS AND APPEARANCE
    TONYMOLY FACE MIX SKIN MAKEUP BASE 02 MIX LAVENDAR SPF20 
    other skin care preparations lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-138
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.6 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.835 g  in 30 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.3 g  in 30 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.3 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
    BORAGO OFFICINALIS WHOLE (UNII: 69R58A6YLI)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WATER (UNII: 059QF0KO0R)  
    NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A)  
    MALTITOL (UNII: D65DG142WK)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-138-011 in 1 CARTON01/19/2016
    130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/14/2016
    Labeler - Tonymoly Co., Ltd. (688216798)
    Registrant - Tonymoly Co., Ltd. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax689049693manufacture(59078-138)