Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion

  • NDC Code(s): 49967-020-01, 49967-020-02, 49967-020-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 21, 2017

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

  • Active ingredient

    Titanium dioxide 11%

  • 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 generously 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 meausures 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, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethcone, iron oxides, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringlidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, disodium stearoyl glutamate, PEG-9

  • Questions or comments?

    1-888-577-5226   1-888-LRP LABO

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    UNDECANE (UNII: JV0QT00NUE)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    NYLON-12 (UNII: 446U8J075B)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIDECANE (UNII: A3LZF0L939)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    TALC (UNII: 7SEV7J4R1U)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-020-011 in 1 CARTON01/30/2017
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49967-020-021 in 1 CARTON01/30/2017
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:49967-020-031 in 1 CARTON01/30/2017
    3125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/30/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-020) , analysis(49967-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interspray364829903pack(49967-020)