Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 49967-907-01, 49967-907-02
  • 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 January 26, 2017

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

  • 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

    - 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 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, propylene glycol, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, PEG-9

  • Questions or comments?

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

    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 MINERAL ULTRA LIGHT SUNSCREEN
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-907
    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 (MW 500000) (UNII: 5Z4DPO246A)  
    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)  
    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)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLYETHYLENE GLYCOL 450 (UNII: 5IRA46LB71)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-907-011 in 1 CARTON07/01/2011
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49967-907-021 in 1 CARTON07/01/2011
    23 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2011
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-907) , analysis(49967-907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interspray364829903pack(49967-907)