Label: SOLEIL TOUJOURS PERPETUAL RADIANCE BROAD SPECTRUM SPF 20- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 58443-0185-2
  • Packager: Prime Enterprises, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 17, 2020

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

  • Active ingredients

    Titanium Dioxide 1.8 % and Zinc Oxide 4.2 %

  • 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
  • Inactive Ingredients

    Acrylates Copolymer, Algin, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Hydroxide, Argania Spinosa Kernel Oil, Ascorbyl Palmitate, Beeswax, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Ceramide 2, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Glyceryl Undecylenate, Guanylcystamine HBr, Hexyl Laurate, Hydrated Silica, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isopropyl Myristate, Laureth-7, Mica, Palmitoyl Hexapeptide-12, PEG-10 Phytosterol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Porphyra Umbilicalis Extract, Propylene Carbonate, Punica Granatum Extract, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium Metabisulfite, Squalane, Stearalkonium Hectorite, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate, Tribehenin, Vitis Vinifera (Grape) Seed Extract, Vitis Vinifera (Grape) Seed Oil, Water  

  • 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

    • SHAKE WELL.
    • Apply liberally 15 minutes before sun exposure
    • Reapply:
    • after 80 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.
  • Questions or comments

    Call toll free 1-877-320-2381

  • PRINCIPAL DISPLAY PANEL - 18mL  Tube with Applicator

    PRINCIPAL DISPLAY PANEL - 18 mL Tube with Applicator

    SOLEIL

    Toujours®

    with

    Dr. Noëlle Sherber

    PERPETUAL

    RADIANCE™

    BROAD SPECTRUM

    SPF 20

    COMPLEXION

    PERFECTING FLUID

    UNIVERSAL TINT

    MINERAL BASED

    SUNSCREEN

    WATER RESISTANT

    (80 MINUTES)

    18 mL e 0.6 FL OZ

  • INGREDIENTS AND APPEARANCE
    SOLEIL TOUJOURS  PERPETUAL RADIANCE BROAD SPECTRUM SPF 20
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0185
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17.6 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION41.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    CARAMEL (UNII: T9D99G2B1R)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOUNDECYLENATE (UNII: IK8A76Q5G8)  
    GUANYLCYSTAMINE HYDROBROMIDE (UNII: PF69H864I0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISODODECANE (UNII: A8289P68Y2)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MICA (UNII: V8A1AW0880)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SQUALANE (UNII: GW89575KF9)  
    ORGOTEIN (UNII: PKE82W49V1)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0185-218 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product07/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/16/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0185) , pack(58443-0185) , manufacture(58443-0185) , analysis(58443-0185)