LUXE ART BEAUTE SAS (69879-108-35) COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.8 INTENSE BEIGE, 35ML (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LUXE ART BEAUTE SAS]

LUXE ART BEAUTE SAS (69879-108-35) COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.8 INTENSE BEIGE, 35ML (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LUXE ART BEAUTE SAS]
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NDC 69879-108-35
Set ID 6fb83041-2e0c-4336-8065-10914354db2f
Category HUMAN OTC DRUG LABEL
Packager Luxe Art Beaute SAS
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredients

    Titanium dioxide 5.1%

    Zinc oxide 2.8%

    Purpose

    Sunscreen

  • Uses

    • Help to 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 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 invcreases your 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.-2 p.m.
      •  Wear long-sleeved 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

    water, cyclopentasiloxane, talc, glycerin, cetyl peg/ppg-10/1 dimethicone, imperata (imperata cylindrica) root extract, sodium chloride, benzyl alcohol, triethoxycaprylylsilane, c12-13 alkyl lactate, alumina, sodium dehydroacetate, hydrogen dimethicone, dimethicone/vinyl dimethicone crosspolymer, fragrance, squalane, disteardimonium hectorite, peg-8, aluminum hydroxide, potassium sorbate, dehydroacetic acid, propylene carbonate, carbomer, phenoxyethanol, sodium citrate, citric acid, biotin may contain: ​titanium dioxide, iron oxides

  • Product Label

    l1

    l2

  • INGREDIENTS AND APPEARANCE
    LUXE ART BEAUTE SAS (69879-108-35) COVER-EXPERT SUNSCREEN BROAD SPECTRUM SPF 15 NO.8 INTENSE BEIGE, 35ML 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69879-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE51 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION28 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BIOTIN (UNII: 6SO6U10H04)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69879-108-3535 mL in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/31/2015
    Labeler - Luxe Art Beaute SAS (378611552)

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