Label: LA ROCHE POSAY FACE BODY ANTHELIOS SPF 60 MELT IN MILK FAST ABSORBING, VELVETY FINISH FOR ALL SKIN TYPES WITH CELL-OC SHIELD XL- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 49967-355-01, 49967-355-02, 49967-355-03, 49967-355-04, view more
    49967-355-05, 49967-355-06
  • 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 December 29, 2022

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

View All Sections
  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 7%

  • 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
  • Warning

    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, sytrene/acrylates copolymer, dimethicone, polymethlysilsesquioxane, butylocytyl salicylate, glycerin, alcohol denat., poly C10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, inulin lauryl carbamate, disodium EDTA, p-anisic acid, caprylic/capric triglyceride, xanthan gum, cassia alata leaf extract, maltodextrin

  • Questions or comments?

    1-888-LRP LABO 1-888-577-5226

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY FACE BODY ANTHELIOS SPF 60 MELT IN MILK FAST ABSORBING, VELVETY FINISH FOR ALL SKIN TYPES WITH CELL-OC SHIELD XL 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-355
    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) HOMOSALATE100 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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TRISILANE (UNII: 1T3A75Z4ZL)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-355-011 in 1 CARTON12/15/2018
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-355-022 mL in 1 PACKET; Type 0: Not a Combination Product04/01/2019
    3NDC:49967-355-031 in 1 CARTON12/15/2018
    350 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:49967-355-041 in 1 CARTON04/01/2019
    4150 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:49967-355-0515 mL in 1 TUBE; Type 0: Not a Combination Product12/15/2018
    6NDC:49967-355-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/15/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA, INC.185931458manufacture(49967-355) , pack(49967-355)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!