BUTTERMILK FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 DELILAH (TITANIUM DIOXIDE) LOTION [DELILAH COSMETICS]

BUTTERMILK FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20 DELILAH (TITANIUM DIOXIDE) LOTION [DELILAH COSMETICS]
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NDC 69000-020-01, 69000-020-02
Set ID 3e542ff1-a37e-45ba-b6c5-1ad0787713f3
Category HUMAN OTC DRUG LABEL
Packager Delilah Cosmetics
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients             Purpose

    Titanium Dioxide  5%        Sunscreen

    Uses

    Helps prevent Sunburn

    If used as directed with other sun protection measures (see Directions), decrease the risk of of skin cancer and early skin aging caused by the sun.

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

    Stop use and ask a doctor if rash occurs.

    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

    Directions

    Apply foundation to a clean face for Broad Spectrum protection. Reapply as needed.

    This is not a primary sunscreen. For further protection by a primary sunscreen follow directions below.

    Apply primary sunscreen liberally 15 minutes before sun exposure

    Reapply: At least 2 hours

    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 15 or higher and other sun protection measures including:

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

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

    Children under 6 months ask doctor.

    Inactive Ingredients: Water/Aqua, Cyclomethicone, Butylene Glycol, Isononyl Isononoate, Behenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, C12-15 Alkyl Benzoate, Disteardimonium Hectorite, Glcyeryl Ethylhexanoate/Stearate/Adipate, Phenoxyethanol, Sucrose Acetyl Isobutyrate, Tocopheryl Acetate, Sodium Chloride, Lauryl PEG-8 Dimethicone, Alumina, Sodium Dehydroacetate, Methicone, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Trisodium Ethylenediamine Dissucinate, Dimethicone, Tropolone, Tripeptide-3, Hexapeptide-3, (May contain (+/-) CI 77891 (Titanium Dioxide), CI 77491 (iron oxides), CI 77492 (Iron Oxides), CI 77499 (Iron Oxides).

  • PRINCIPAL DISPLAY PANEL

    Delilah

    Time Frame Future resist Foundation Broad Spectrum SPF 20   Buttermilk

    Fond de Teint SPF 20 Anti Vieillissement

    Foundation Sunscreen

    1.28 Fl OZ./36 ml

    Secondary

    Primary

  • INGREDIENTS AND APPEARANCE
    BUTTERMILK FUTURE RESIST FOUNDATION BROAD SPECTRUM SPF 20  DELILAH
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69000-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69000-020-021 in 1 CARTON
    1NDC:69000-020-0138 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/13/2014
    Labeler - Delilah Cosmetics (219906475)
    Registrant - Delilah Cosmetics (219906475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gotha Cosmetics SRL378071679manufacture(69000-020)

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