Label: COMPLEXION PERFECTION BB- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 December 14, 2022

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  • Active Ingredients

    Titanium Dioxide 5.0%

    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.
  • For external use only

    Do not use

    on damaged or broken skin

    Stop use and ask a doctor if

    rash occurs

    When using this product

    keep out of eyes. Rinse with water to remove

    keep out of reach of children

    If swallowed, get medical help or contact a poison Control Center right away.

  • Inactive Ingredients

    Alumina, Borago Officinalis Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteareth-20, Catearyl Alcohol, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hydrogenated Vegetable Oil, Hydroxypropyl Cyclodextrin, Iron Oxide CI-77492, Iron Oxide CI-77499, Iron Oxide CI-77491, Kojic Dipalmitate, Niacinamide, Olea Europaea (Olive) Fruit Oil, Palmitoyl Tripeptide-38, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-2 Caprate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hyaluronate, Sorbic Acid, Squalane, Stearic Acid, Sucrose Stearate, Titanium Dioxide CI-77891, Tocopheryl Acetate, Urea, Water, Xanthan Gum.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • reapply : 
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months : Ask a doctor
    • 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 value 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-sleeved shirts, pants, hats, and sunglass
    • children under 6 months: Ask a doctor.    
  • Other Information

    • protect this product from excessive heat and direct sun
    • may stain some fabrics.
  • Questions or comments?

    Scan the QR Code below,

    visit www.halecosmeceuticals.com,

    or call toll-free 800-951-7005.

  • Package Labeling

    Label 002

  • INGREDIENTS AND APPEARANCE
    COMPLEXION PERFECTION BB 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71987-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    KOJIC DIPALMITATE (UNII: 13N249RWTM)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBIC ACID (UNII: X045WJ989B)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71987-002-0030 mL in 1 TUBE; Type 0: Not a Combination Product01/09/201812/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/09/201812/31/2024
    Labeler - Hale Comeceuticals (168405822)