Label: VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT- titanium dioxide lotion

  • NDC Code(s): 49967-650-01
  • Packager: L’Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • Active ingredients

    Titanium dioxide 14.8%

  • 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

    For sunscreen use:

    • shake well before use

    ●  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 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 sunglasses

    ●  children under 6 months of age: Ask a doctor

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • store at 68 – 77° F (20 – 25°C)
  • Inactive ingredients

    water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

  • Questions or comments?

    Call toll free 1-877-378-4249

    Monday - Friday (9 a.m. to 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-650
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE148 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    UNDECANE (UNII: JV0QT00NUE)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    NYLON-12 (UNII: 446U8J075B)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    TRIDECANE (UNII: A3LZF0L939)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-650-011 in 1 CARTON12/01/2019
    145 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2019
    Labeler - L’Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-650) , pack(49967-650)
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