Label: EVERGLAM BB NATURAL BEIGE- titanium dioxide, octinoxate, and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 28, 2017

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  • 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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