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%

    Close
  • Purpose

    Sunscreen

    Close
  • 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.

    Close
  • 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.

    Close
  • 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

    Close
  • Other Information

    Protect this product from excessive heat and direct sun

    Close
  • 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)

    Close
  • 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.

    Close
  • PRINCIPAL DISPLAY PANEL

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

    Close
  • Product Label
  • INGREDIENTS AND APPEARANCE
    3LAB PERFECT BB SPF 40 BROAD SPECTRUM 01 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76159-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 121.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE 5  
    BUTYLENE GLYCOL  
    ALUMINUM STARCH OCTENYLSUCCINATE  
    ASCORBYL GLUCOSIDE  
    CAPRYLYL TRISILOXANE  
    GLYCERETH-26  
    NEOPENTYL GLYCOL DICAPRATE  
    PHENYL TRIMETHICONE  
    DIMETHICONE  
    ALUMINUM OXIDE  
    DIPROPYLENE GLYCOL  
    SODIUM CHLORIDE  
    SQUALANE  
    ACHILLEA MILLEFOLIUM  
    SHEA BUTTER  
    CHAMOMILE  
    FENNEL SEED  
    HOPS  
    MELISSA OFFICINALIS LEAF  
    VISCUM ALBUM FRUITING TOP  
    OLIVE OIL  
    .ALPHA.-TOCOPHEROL ACETATE  
    ADENOSINE  
    TOCOPHEROL  
    HYALURONATE SODIUM  
    ALLANTOIN  
    CERAMIDE 3  
    GLYCERIN  
    PEG/PPG-20/15 DIMETHICONE  
    PEG/PPG-18/18 DIMETHICONE  
    SILICON DIOXIDE  
    SODIUM OLEATE  
    SODIUM PYRROLIDONE CARBOXYLATE  
    TRIETHOXYCAPRYLYLSILANE  
    UREA  
    XANTHAN GUM  
    PANTHENOL  
    POTASSIUM HYDROXIDE  
    GLYCYRRHIZINATE DIPOTASSIUM  
    SODIUM PHOSPHATE  
    CAPRYLYL GLYCOL  
    BORON NITRIDE  
    ALCOHOL  
    EDETATE DISODIUM  
    EDETIC ACID  
    PHENOXYETHANOL  
    ORANGE OIL  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    FERROSOFERRIC OXIDE  
    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)
    Close