Label: SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 49967-077-01, 49967-077-02, 49967-077-03, 49967-077-04
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active ingredients

    Titanium dioxide 6%

    Zinc oxide 5%

  • 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 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 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

  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-811-1660

    Monday - Friday (9 a.m. - 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    SKINCEUTICALS PHYSICAL FUSION UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    NYLON-12 (UNII: 446U8J075B)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIDECANE (UNII: A3LZF0L939)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-077-011 in 1 CARTON01/01/2011
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-077-024 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2011
    3NDC:49967-077-03125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2011
    4NDC:49967-077-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics LP007317209manufacture(49967-077)
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