EVERGLAM BB NATURAL BEIGE (TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE) CREAM [GLAMCOS L.L.C.]

EVERGLAM BB NATURAL BEIGE (TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE) CREAM [GLAMCOS L.L.C.]
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NDC 71667-200-01
Set ID 9c60a62e-02d5-4d5c-abf9-f6912c93f11d
Category HUMAN OTC DRUG LABEL
Packager Glamcos L.L.C.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 7.920%Sunscreen
    Octinoxate 2.99%Sunscreen
    Zinc Oxide 1.900%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases 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.

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if a rash occurs.

    Keep out 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
    • If swimming or sweating, use a water resistant sunscreen
    • Children under 6 months: Consult a doctor
    • Sun Protection Measures:
      Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      -
      Limit time spent in the sun, especially from 10 a.m. - 2p.m.
      -
      Wear protective cloths, hats & sunglasses
  • Other information

    • Keep this product away from direct sunlight and excessive heat
    • You may report a serious adverse event from use of this product to: GlamCos LLC, 708 Third Ave, 6th Floor, New York, NY 10017
  • Inactive ingredients

    Water, Cyclopentasiloxane, Glycerin, TALC, Dipropylene Glycol, PEG-10 Dimethicone, Hexyl Laurate, Dimethicone, Disteardimonium Hectorite, Betaine, Isoeicosane, Iron Oxides(CI 77492), Magnesium Sulfate, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides(CI 77499), Iron Oxides(CI 77491), Acrylates/Dimethicone Copolymer, Phenoxyethanol, Methicone, Palmitic Acid, Ethylhexylglycerin, Portulaca Oleracea Extract, Tocopheryl Acetate, Fragrance, Aluminum Hydroxide, Aluminum Stearate, Butylated Hydroxytoluene, Sagassum Fulvellum Extract, Butylene Glycol, 1,2-Hexanediol

  • Questions & Comments?

    Call 800-922-8459

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

    EverGlam
    Advanced Skincare

    BB
    BEAUTY BALM
    FOR FLAWLESS COVERAGE

    NATURAL BEIGE

    ADVANCED MULTI- ACTION
    SKINCARE + MAKEUP

    • Concealing Skin Imperfections
    • Moisturizing with Oil Control
    • Rejuvenating and Anti-Wrinkle
    • Sunscreen

    Broad Spectrum
    SPF 30

    50 mL / 1.7 fl. oz.

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    EVERGLAM BB NATURAL BEIGE 
    titanium dioxide, octinoxate, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71667-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE79.2 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate29.9 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Talc (UNII: 7SEV7J4R1U)  
    Dipropylene Glycol (UNII: E107L85C40)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Betaine (UNII: 3SCV180C9W)  
    Isoeicosane (UNII: AR294KAG3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methicone (20 Cst) (UNII: 6777U11MKT)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    PURSLANE (UNII: M6S840WXG5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    ALUMINUM MONOSTEARATE (UNII: P9BC99461E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Sargassum Fulvellum (UNII: 245PL7LPSU)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71667-200-011 in 1 BOX09/15/2017
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/15/2017
    Labeler - Glamcos L.L.C. (080544953)

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