Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

  • NDC Code(s): 49967-008-01
  • 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 November 18, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 2.68%

    Homosalate 9.6%

    Octisalate 2.88%

    Octocrylene 5.38%

    Oxybenzone 3.46%

    Close
  • Purpose

    Sunscreen

    Close
  • 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
    Close
  • Warnings

    For external use only

    Close
  • Do not use

    on damaged or broken skin

    Close
  • When using this product

    • keep out of eyes. Rinse with water to remove.
    • keep away from face to avoid breathing it
    Close
  • Stop use and ask a doctor if

    rash occurs

    Close
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    For sunscreen use:

    ●  spray generously and spread evenly by hand 15 minutes before sun exposure

    ● hold container 4 to 6 inches from the skin to apply

    ● do not spray directly into face. Spray on hands then apply to face.

    ● do not apply in windy conditions

    ● use in a well-ventilated area

    ●  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

    Close
  • Other information

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

    Close
  • Inactive ingredients

    water, dimethicone, isopropyl lauroyl sarcosinate, glycerin, styrene/acrylates copolymer, isotridecyl isononanoate, polyurethane-35, caprylyl methicone, octyldodecanol, phenoxyethanol, propylene glycol, caprylyl glycol, sodium stearoyl glutamate, polysorbate 61, glyceryl stearate, PEG-8 laurate, dimethiconol, octyldodecyl xyloside, PEG-12 dimethicone, p-anisic acid, stearyl alcohol, disodium EDTA, tocopherol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

    Close
  • Questions or comments?

    1-888-LRP-LABO  1-888-577-5226

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

    Close
  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES 
    avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-008
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 26.8 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 96 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 28.8 mg  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 53.8 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 34.6 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-008-01 143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2014
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    Name Address ID/FEI Business Operations
    Accra Pac, Inc. 024213616 manufacture(49967-008)
    Establishment
    Name Address ID/FEI Business Operations
    L'Oreal USA, Inc. 960317444 manufacture(49967-008)
    Establishment
    Name Address ID/FEI Business Operations
    L'Oreal USA, Inc. 185931458 manufacture(49967-008)
    Close