LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE PIGMENTCLAR DAILY DARK SPOT CORRECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'ORE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE PIGMENTCLAR DAILY DARK SPOT CORRECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'ORE
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NDC 49967-664-01, 49967-664-02
Set ID 197ea8bf-0d84-42cb-bf29-087ad9587877
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 5%

    Octisalate 5%

    Octocrylene 7%

  • 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, alcohol denat., niacinamide, dimethicone, sucrose tristearate, pentaerythrityl tetraethylhexanoate, polysorbate 61, sodium stearoyl guytamate, phenoxyethanol, phenylethyl resorcinol, propylene glycol, capryloyl salicylic acid, ammonium polyacryloyldimethyl taurate, caprylyl glycol, carbomer, xanthan gum, disodium EDTA, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, ginkgo biloba leaf extract, sodium hydroxide, ferulic acid

  • 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 label

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE PIGMENTCLAR DAILY DARK SPOT CORRECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-664
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-664-011 in 1 CARTON08/01/2014
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-664-021 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
    Dimensional Merchandising Inc.076693183manufacture(49967-664)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-664)

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