3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]

3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]
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NDC 76159-006-00
Set ID 8a42a9d8-b9c6-45fb-8264-15f36e2765f0
Category HUMAN OTC DRUG LABEL
Packager 3LAB, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 3LAB Aqua BB SPF 40 BROAD SPECTRUM #03


  • Active Ingredients

    Titanium Dioxide 7.86%

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

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply
      - After 40 minutes of swimming or sweating
      - Immediately after towel drying
      - At least every 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 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 : Ask a doctor
  • Other Information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Cyclopentasiloxane, Rosa Centifolia Flower Water, Water (Aqua/Eau), Butylene Glycol, Butyloctyl Salicylate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Lactobacillus Fermentum, Dimethicone, Sodium PCA, Glycerin, Alumina, Trisiloxane, Glycereth-26, Sodium Hyaluronate, Adenosine, Dimethicone/PEG-10/15 Crosspolymer, Alteromonas Ferment Extract, Dipotassium Glycyrrhizate, Allantoin, Beta-Glucan, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopheryl Acetate, Carbomer, Methicone, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Hydrolyzed Wheat Protein/PVP Crosspolymer, Polysorbate 20, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Phenoxyethanol, Citrus Aurantium Dulcis Oil, Lavandula Angustifolia (Lavender) Oil
    May contain:
    Titanium Dioxide, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499)

  • 3LAB Aqua BB SPF 40 BROAD SPECTRUM #03 28ml (76159-006-00)

    Bottom LabelAqua BB 3

  • INGREDIENTS AND APPEARANCE
    3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE78.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ADENOSINE (UNII: K72T3FS567)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76159-006-001 in 1 CARTON12/19/2017
    128 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/18/2013
    Labeler - 3LAB, Inc. (162333277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(76159-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(76159-006)

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