Label: VICHY LABORATOIRES AQUALIA THERMAL UV DEFENSE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 49967-869-01, 49967-869-02
  • Packager: L'Oreal USA Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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

  • Active ingredients

    Avobenzone 3%

    Homosalate 5%

    Octisalate 5%

    Octocrylene 7%

  • 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

  • Keep out of reach of children.

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

  • 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

  • Directions

    For sunscreen use:

    ● apply liberally 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 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, glycerin, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, mannose, stearic acid, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, sodium PCA, myristic acid, palmitic acid, ammonium polyacryloyldimethyl taurate, tocopherol, capryloyl glycine, caprylyl glycol, trisodium ethylenediamine disuccinate, xanthan gum, cetyl alcohol, fragrance

  • Questions or comments?

    Call toll free 1-877-378-4249

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    VICHY LABORATOIRES AQUALIA THERMAL UV DEFENSE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-869
    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) HOMOSALATE50 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MANNOSE, D- (UNII: PHA4727WTP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CERAMIDE NP (UNII: 4370DF050B)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-869-011 in 1 CARTON05/27/2019
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-869-021.5 mL in 1 PACKET; Type 0: Not a Combination Product05/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/27/2019
    Labeler - L'Oreal USA Products Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-869) , pack(49967-869)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(49967-869)