Label: LA ROCHE POSAY NEW 50 BODY AND FACE SPF 50 MINERAL ANTHELIOS GENTLE 100 PERCENT MINERAL UV FILTERS SOFT FINISH WITH CELL OX SHIELD- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 49967-091-01, 49967-091-02, 49967-091-03, 49967-091-04, view more
    49967-091-05
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • Drug Facts

    Titanium dioxide 5%

    Zinc Oxide 15%

  • 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 cuased 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:

    • apply generously 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 is this container from excessive heat and direct sun
  • Inactive ingredients

    water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

  • Questions or comments?

    1-888-LRP-LABO 1-888-577-5226

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

  • PRINCIPAL DISPLAY PANEL

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    image description
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY NEW 50 BODY AND FACE SPF 50 MINERAL ANTHELIOS GENTLE 100 PERCENT MINERAL UV FILTERS SOFT FINISH WITH CELL OX SHIELD 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-091-01120 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    2NDC:49967-091-0290 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    3NDC:49967-091-035 mL in 1 PACKET; Type 0: Not a Combination Product12/15/2018
    4NDC:49967-091-045 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    5NDC:49967-091-05150 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/15/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.185931458manufacture(49967-091)
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