Label: LA ROCHE POSAY ANTHELIOS 30 ULTRALIGHT SUNSCREEN- avobenzone homosalate octisalate octocrylene oxybenzone spray

  • NDC Code(s): 49967-085-01
  • 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 February 2, 2012

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  • Active ingredients

    Avobenzone 3%

    Homosalate 12%

    Octisalate 5%

    Octocrylene 7%

    Oxybenzone 6%


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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water or perspiring
    • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin
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  • Warnings

    For external use only

    When using this product

    • keep out of eyes. Rinse with water to remove.
    • keep away from face to avoid breathing it

    Stop use and ask a doctor if

    • rash or irritation develops and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


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  • Directions



    • hold can 4 - 6 inches away from body and apply liberally and evenly before sun exposure
    • for face, do not spray directly on face; spray into hands and apply using fingers
    • reapply as needed or after towel drying,swimming, or perspiring
    • children under 6 months of age: ask a doctor
    • do not apply in windy conditions
    • use in a well-ventilated area
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  • Inactive ingredients

    dimethicone, water, isododecane, isononyl isononanoate, PEG-10 dimethicone, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dicaprylyl carbonate, trisiloxane, dimethicone/PEG-10/15 crosspolyer, sodium chloride, phenoxyethanol, propylene glycol, PEG-8 laurate, disteardimonium hectorite, tocopherol, disodium EDTA, p-anisic acid, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, propylene carbonate

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  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY  ANTHELIOS 30 ULTRALIGHT SUNSCREEN
    avobenzone homosalate octisalate octocrylene oxybenzone spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-085
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 4.29 g  in 143 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 17.16 g  in 143 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 7.17 g  in 143 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10.01 g  in 143 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 8.58 g  in 143 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-085-01 143 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2012
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    Name Address ID/FEI Business Operations
    Assured Packaging 248916165 manufacture
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