LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC (OCTINOXATE, OCTISALATE, OCTOCRYLENE AND TITANIUM DIOXIDE) CREAM [L'OREAL

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC (OCTINOXATE, OCTISALATE, OCTOCRYLENE AND TITANIUM DIOXIDE) CREAM [L'OREAL
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NDC 49967-422-01, 49967-422-02
Set ID 39e94e53-c34f-46f4-bcf9-e4d5f7a61380
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients


    Octinoxate 3%

    Octisalate 3.5%

    Octocrylene 4.5%

    Titanium dioxide 6.2%

  • 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:

    ● apply generously 15 minutes before sun exposure

    ● reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    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, glycerin, butyrospermum parkii (shea) butter, diisopropyl sebacate, C30-45 alkyl dimethicone, dimethicone, butylene glycol, sucrose tristearate, ammonium polyacryloyldimethyl taurate, methylsilanol/silicate crosspolymer, polysorbate 61, fragrance, tocopheryl acetate, sodium stearoyl glutamate, phenoxyethanol, PEG-12 dimethicone, ethylhexylglycerin, tambourissa trichophylla leaf extract, dimethiconol, xanthan gum, caprylyl glycol, disodium EDTA; may contain: mica, iron oxides, titanium dioxide

  • 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 ROSALIAC DAILY COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC 
    octinoxate, octisalate, octocrylene and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-422
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE62 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
    POLYSORBATE 61 (UNII: X9E1MY2JQG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-422-011 in 1 CARTON08/01/2014
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-422-021 in 1 CARTON08/01/2014
    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 finalpart35208/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-422)

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