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EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 (Pierre Fabre Dermo Cosmetique)

Available Formats

Dosage Form Package Information Links
CREAM 40 mL in 1 TUBE (67015-0002-0) Label Information

Complete EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 Information

  • Active Ingredients

    OCTOCRYLENE 8%

    OCTINOXATE 7.5%

    TITANIUM DIOXIDE 3.2%


  • 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 skin 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



  • Questions or comments?

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

    www.aveneusa.com


  • Inactive Ingredients

    WATER/EAU (AQUA), CYCLOMETHUCONE, GLYCERIN, ETHYLHEXYL PALMITATE, STEARLY ALCOHOL, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE ALUMINA, BENZOIC ACID, BETA.SITOSTEROL, BHT, CAPRYLIC/CAPRIC TRIGYLCERIDE, CHLORPHENESIN, DISODIUM EDTA, GLYCINE SOJA (SOYBEAN) SEED EXTRACT ( GLYCINE sOJA), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYDIMETHYL TAURATE COPOLYMER, PHENOXYETHANOL, PEG-32 PEG-400 PLOXAMER 188, POLYSORBATE 60, SIMETHICONE, SODIUM CHONDROITIN, SULFATE, SORBITAN ISOSTEARATE, SQUALANE, TOCOPHERYL GLUCOSIDE, XANTHAN GUM.


  • Other Information

    Protect this product from excessive heat and direct sun.


  • EAU THERMALE Avene Hydrance Optimale Hydrating Cream BROAD SPECTRUM SPF 25 40ml/1.35 (67015-0002-0)


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  • INGREDIENTS AND APPEARANCE
    EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 
    titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67015-0002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67015-0002-0 40 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/29/2013
    Labeler - Pierre Fabre Dermo Cosmetique (378028104)
    Registrant - Pierre Fabre Dermo Cosmetique (378028104)
    Establishment
    Name Address ID/FEI Business Operations
    Pierre Fabre Dermo Cosmetique 572614688 manufacture(67015-0002)