LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODU

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODU
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NDC 49967-392-01, 49967-392-02
Set ID d7bf3928-85b8-4e5f-a04a-d520130a3340
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 2.24%

    Homosalate 8%

    Octisalate 2.4%

    Octocrylene 4.48%

    Oxybenzone 2.88%

  • 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:

    ● 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 in this container from excessive heat and direct sun

  • Inactive ingredients

    water, alcohol denat., dimethicone, cyclopentasiloxane, acrylates/dimethicone copolymer, phenoxyethanol, propylene glycol, capryly glycol, sodium polyacrylate, silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, tocopherol, methyl lactate, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

  • Questions or comments?

    1-888-LRP-LAB0 1-888-577-5226

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

  • PRINCIPAL DISPLAY PANEL

    image of a tube

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 30 COOLING WATER BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-392
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE22.4 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE24 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.8 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE28.8 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-392-01150 mL in 1 TUBE
    2NDC:49967-392-025 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, INC.185931458manufacture(49967-392)

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