Label: CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CR- ensulizole, octisalate emulsion

  • NDC Code(s): 61957-2404-0, 61957-2404-1
  • Packager: Parfums Christian Dior
  • 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 June 1, 2021

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

  • Drug Facts

  • Active ingredients

    Ensulizole 2.70 %
    Octisalate 4.50 %

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • 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 a doctor if

    rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    • AQUA (WATER) • DIMETHICONE • METHYL TRIMETHICONE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • PHENYL TRIMETHICONE • SYNTHETIC FLUOROPHLOGOPITE • GLYCERIN • PENTYLENE GLYCOL • SILICA • BUTYLENE GLYCOL• SORBITAN SESQUIOLEATE • TROMETHAMINE • ACRYLATES/DIMETHICONE COPOLYMER • MICA • DIMETHICONOL • PARFUM (FRAGRANCE) • SODIUM MYRISTOYL GLUTAMAT • GLYCERYL UNDECYL DIMETHICONE • CHLORPHENESIN • CAPRYLYL GLYCOL• SODIUM CHLORIDE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • POLYSORBATE 80 • HYDROGEN DIMETHICONE • ALUMINUM HYDROXIDE • ADENOSINE• SODIUM ACETYLATED HYALURONATE • XYLITOL • TOCOPHEROL • SODIUM SURFACTIN • AFRAMOMUM ANGUSTIFOLIUM SEED EXTRACT • PALMARIA PALMATA EXTRACT • SODIUM BENZOATE • HYDROLYZED SOY PROTEIN • PAEONIA LACTIFLORA ROOT EXTRACT • TREHALOSE • POTASSIUM SORBATE • LILIUM CANDIDUM BULB EXTRACT • JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT.
    [MAY CONTAIN:CI 77491,CI 77492,CI 77499 (IRON OXIDES) • CI 77891 (TITANIUM DIOXIDE) • CI 77947 (ZINC OXIDE)]. N °15310/Z

  • Package Labeling:61957-2404-0

    Inner Package5Outer Package5Label5

  • Package Labeling:61957-2404-1

    TESTER4

  • INGREDIENTS AND APPEARANCE
    CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CR 
    ensulizole, octisalate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61957-2404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE27 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ADENOSINE (UNII: K72T3FS567)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    AFRAMOMUM ANGUSTIFOLIUM SEED (UNII: OSF83Q896J)  
    PALMARIA PALMATA (UNII: 7832HOY4ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    TREHALOSE (UNII: B8WCK70T7I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61957-2404-030 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
    2NDC:61957-2404-120 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2021
    Labeler - Parfums Christian Dior (275252245)