Label: THEFACESHOP CUSHION CC SPF 50 NATURAL BEIGE OIL-FREE- ensulizole, titanium dioxide 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 December 13, 2021

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

  • ACTIVE INGREDIENTS

    Ensulizole 2.7%

    Titanium Dioxide 5.46%

  • PURPOSE

    SUNSCREEN

  • USES

    • Helps prevent sunbrun
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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 doctor rash or irritation develops and lasts.

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

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply as needed or after towel drying, swimming, or sweating.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    - Limit time in the sun, especially from 10 a.m. to 2 p.m.

    - Wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENTS

    CYCLOPENTASILOXANE, WATER, TRIETHYLHEXANOIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, DIPROPYLENE GLYCOL, TROMETHAMINE, 1,2-HEXANEDIOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ZINC STEARATE, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, STEARIC ACID, SORBITAN SESQUIISOSTEARATE, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, CITRUS UNSHIU PEEL EXTRACT, BUTYLENE GLYCOL, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PHENOXYETHANOL, PALMITIC ACID, BIOSACCHARIDE GUM-1, CALCIUM CARBONATE, SILICA, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA(CI 77019), IRON OXIDES(CI 77491, CI 77492, CI 77499)

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun. Store at 15 - 30 °C
  • QUESTIONS?

    Call 1-888-498-9004

  • PRINCIPAL DISPLAY PANEL

    CC OIL-FREE
    CUSHION

    BROAD SPECTRUM
    SPF 50

    THEFACESHOP
    Net Wt. 0.52 oz | 15g

    V203 NATURAL BEIGE

    THEFACESHOP
    CC OIL-FREE CUSHION

    MOIST COVER | FRESH FIT
    [Broad Spectrum SPF 50]

    Imported by LG H&H USA, INC.
    165 BROADWAY, ONE LIBERTY PLAZA, 25TH FLOOR
    NEW YORK, NY 10006, USA

    Questions: 1-888-498-9004 / MADE IN KOREA

    TFS CC Oil-Free Cushion SPF 50 Natural Beige

  • INGREDIENTS AND APPEARANCE
    THEFACESHOP CUSHION CC SPF 50 NATURAL BEIGE  OIL-FREE
    ensulizole, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72330-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.819 g  in 15 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PALMITOYL PROLINE (UNII: I49727TDYF)  
    TANGERINE PEEL (UNII: JU3D414057)  
    ADENOSINE (UNII: K72T3FS567)  
    MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72330-053-032 in 1 BOX02/04/2021
    115 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 finalpart35202/04/2021
    Labeler - fmg Co.Ltd (690188305)
    Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    fmg Co.Ltd690188305manufacture(72330-053)