Label: CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER- avobenzone, octinoxate, octisalate, octocrylene cream

  • NDC Code(s): 70186-700-01
  • Packager: Charlotte Tilbury Beauty Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 15, 2022

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

  • DRUG FACTS Active ingredients

    Avobenzone 3.00%

    Octinoxate 6.79%

    Octisalate 4.50%

    Octocrylene 2.00%

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

  • Directions

    • apply liberally and evenly 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if 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 value of 15 or higher and other sun protection measures including:

    - limit time in the sun, especially from 10 am - 2pm

    - wear long-sleeved shirts, pants, hats, and sunglasses

  • Inactive ingredients

    Water, Butylene Glycol, Diethylhexyl Succinate, Glycerin, Dextrin Palmitate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, PEG-60 Glyceryl Isostearate, Marrubium Vulgare Extract, Titanium Dioxide (CI 77891), Polyglyceryl-2 Triisostearate, Talc, Hydroxypropyl Methylcellulose Stearoxy Ether, Polysorbate 60, Sorbitan Isostearate, Agar, Tocopherol, Xanthan Gum, Iron Oxides (CI 77492), Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Sodium Hyaluronate, Iron Oxides (CI 77491), Khaya Senegalensis Bark Extract, Maltodextrin, Citric Acid, BHT, Ascorbyl Glucoside, Camellia Oleifera Seed Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oil, Sodium Hydroxide, Iron Oxides (CI 77499), Plumeria Alba Flower Extract, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Solanum Tuberosum (Potato) Pulp Extract, Ascorbyl Dipalmitate.

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    Charlotte Tilbury

    BROAD SPECTRUM

    SPF 50

    SUNSCREEN

    INVISIBLE UV

    FLAWLESS

    PRIMER

    30 mL

    Outer Label - 30 mL CartonInner Label - 30 mL Carton

  • INGREDIENTS AND APPEARANCE
    CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER 
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70186-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.038 g  in 30 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.918 g  in 30 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.377 g  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.612 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    AGAR (UNII: 89T13OHQ2B)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE 2910 0.45% STEAROXY ETHER (UNII: HG3GR8HU7X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    ASCORBYL DIPALMITATE (UNII: 624RX3IESR)  
    HOREHOUND (UNII: K08036XEJV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)  
    PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTATO PULP (UNII: 844I2DX0IS)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    WATER (UNII: 059QF0KO0R)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    KHAYA SENEGALENSIS BARK (UNII: 1S7EDA839L)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70186-700-011 in 1 CARTON05/19/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/19/2022
    Labeler - Charlotte Tilbury Beauty Ltd. (218353520)