Label: 3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 - titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active Ingredients

    Titanium Dioxide 12.16%

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  • Purpose

    Sunscreen

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  • 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.

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  • 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.

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  • 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

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  • Other Information

    Protect this product from excessive heat and direct sun

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  • Inactive Ingredients

    Water (Aqua/Eau),Cyclopentasiloxane, Butylene Glycol, Aluminum Starch Octenylsuccinate, Cetyl PEG/PPG-10/1Dimethicone, PEG-10 Dimethicone, Ascorbyl Glucoside, Caprylyl Methicone, Glycereth-26, Neopentyl Glycol Dicaprate, Phenyl Trimethicone, Dimethicone, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol,Sodium Chloride, Disteardimonium Hectorite, Squalane, Achillea Millefolium Extract, Butyrospermum Parkii (Shea Butter), Chamomilla Recutita (Matricaria) Flower Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Humulus Lupulus (Hops) Extract, Malus Domestica Fruit Cell Culture, Melissa Officinalis Leaf Extract, Viscum Album (Mistletoe) Leaf Extract, Olea Europaea (Olive) Fruit Oil, Hydrolyzed Pea Protein, Tocopheryl Acetate, Adenosine, Oligopeptide-68, Rh-Polypeptide-7, Tocopherol, Sodium Hyaluronate, Allantoin, Beta-Glucan, Ceramide 3, Glycerin, Hydrogenated Lecithin, Lecithin, Methicone, Hydroxyethylcellulose, PEG/PPG-20/15 Dimethicone, PEG/PPG-18/18 Dimethicone, Phytosterols, Silica, Sodium Oleate, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Triethoxycaprylylsilane, Urea, Xanthan Gum, Panthenol, Potassium Hydroxide, Dipotassium Glycyrrhizate, Sodium Phosphate, Caprylyl Glycol, Boron Nitride, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol, Disodium EDTA, EDTA, Phenoxyethanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Fragrance May contain:
    Iron Oxides (C.I. 77491) Iron Oxides (C.I. 77492) Iron Oxides (C.I. 77499)

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  • PERFECT BB SPF 40/PA+++

    Infused with 3LAB’s signature bioengineered growth hormone and apple stem cell technology, PERFECT BB SPF 40 is a sheer tinted moisturizer designed to firm and lift the skin, regenerate new skin cells, brighten, moisturize, and protect.


    Directions Apply to cleansed skin.

    BIORIUS sprl,2 rue René Descartes,B-7000 Mons, Belgium Distributed by 3LAB,® Inc., Englewood, NJ 07631, U.S.A. www.3LAB.com / Made in U.S.A.

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  • PRINCIPAL DISPLAY PANEL

    3LAB  PERFECT BB SPF 40  BROAD SPECTRUM  #01 NET WT. 1.5 OZ. 45 mL e

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  • Product Label
  • INGREDIENTS AND APPEARANCE
    3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76159-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 121.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SQUALANE (UNII: GW89575KF9)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    HOPS (UNII: 01G73H6H83)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE (UNII: K72T3FS567)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    UREA (UNII: 8W8T17847W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    ALCOHOL (UNII: 3K9958V90M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76159-001-00 1 in 1 CARTON
    1 45 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/10/2013
    Labeler - 3LAB, Inc (162333277)
    Establishment
    Name Address ID/FEI Business Operations
    Englewood Lab, LLC 172198223 manufacture(76159-001)
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