Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN- avobenzone homosalate octisalate octocrylene oxybenzone lotion

  • NDC Code(s): 49967-095-01
  • 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 March 16, 2012

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  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Oxybenzone 6%

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  • Uses

    • helps prevent sunburn
    • if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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  • 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.

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  • 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 of 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

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  • Purpose

    Sunscreen

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  • Other information

    • protect the product in this container from excessive heat and direct sun
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  • Inactive ingredients

    dimethicone, C12-15 alkyl benzoate, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

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  • Questions or comments?

    1-888-LRP-LABO  1-888-577-5226

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

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE  ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN
    avobenzone homosalate octisalate octocrylene oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-095
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 1.2 mL  in 40 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 4 mL  in 40 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 2 mL  in 40 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2 mL  in 40 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 2.4 mL  in 40 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-095-01 1 in 1 CARTON
    1 40 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/05/2012
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    Name Address ID/FEI Business Operations
    L'Oreal USA Products Inc 185931458 manufacture
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