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

  • NDC Code(s): 49967-929-01, 49967-929-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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

  • Active ingredients

    Titanium dioxide 9%

    Zinc oxide 4%

  • 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 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

  • Inactive ingredients

    dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 laureth, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyul glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

  • 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 MATTE UV DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-929
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TALC (UNII: 7SEV7J4R1U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    2-OLEAMIDO-1,3,4-OCTADECATRIYL PROLINATE (UNII: 690VHX6497)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-929-011 in 1 CARTON03/01/2015
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-929-021 in 1 CARTON03/01/2015
    24 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2015
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics LP007317209manufacture(49967-929)