EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25 (OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]

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  • EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25 (OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]

EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25 (OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]
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NDC 67015-0001-0
Set ID 5494a677-58e7-423e-b178-93d18f65558f
Category HUMAN OTC DRUG LABEL
Packager Pierre Fabre Dermo-Cosmetique USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    OCTOCRYLENE 4%

    OCTINOXATE 7.5%

    TITANIUM DIOXIDE 4.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions) decreases the risk if skin cancer and early skin aging caused by the sun.
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply 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 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: Ask a doctor


  • Inactive ingredients

    WATER (AQUA) EAU, CYCOMETHICONE, GLYCERIN, ETHYLHEXYL PALMITATE, POTASSIUM CETYL PHOSPHATE, C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, ALUMINA, BHT, BLUE 1 (CI 42090), BUTYLPARABEN, DEXTRAN SULFATE,  DISODIUM EDTA, ETHYLPARABEN, FRAGRANCE (PARFUM), HESPERIDIN METHYL CHALCONE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOBUTYLPARABEN, MAGNESIUM ALUMINUM SILICATE,  METHYLPARABEN, O-CYMEN-5-OL, PHENOXYETHANOL, POLYSORBATE 60, PROPYLPARABEN, RUSCUS ACULEATUS ROOT EXTRACT (RUSCUS ACULEATUS), SQUALANE, STEARIC ACID, TRIBEHENIN, XANTHAN GUM.

  • Other information

    protect this product from excessive heat and direct sunlight.

  • Questions

    1-866-41-AVENE (USA) / 1-877-441-2011 (CAN)

    www.aveneusa.com

  • Principal Display Panel - 40 ml Carton

    EAU THERMALE

    Avene

    Antirougeurs

    DAY

    Redness-relief

    soothing cream

    BROAD SPECTRUM SPF 25

    DIN 02273594

    For sensitive skin

    HYPOALLERGENIQUE•NON COMEDOGENE

    PARIS

    40ml  e/1.35 FL.OZ

    EAU THERMALE Avene Antirougeurs DAY Redness-relief soothing Cream Carton Labe






  • INGREDIENTS AND APPEARANCE
    EAU THERMALE AVENE ANTIROUGEURS DAY REDNESS-RELIEF SOOTHING BROAD SPECTRUM SPF 25 
    octocrylene, octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67015-0001-040 mL in 1 TUBE; Type 0: Not a Combination Product04/29/201306/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/29/201306/30/2022
    Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)
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