EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]

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  • EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]

EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO-COSMETIQUE USA, INC.]
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NDC 67015-0033-0
Set ID 03417efd-941d-4ed7-9c9a-4b6183141ae7
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

    OCTINOXATE 7.5%

    OCTOCRYLENE 8%

    TITANIUM DIOXIDE 3.2%

  • Purpose

    • Hydrance Optimale SPF 25 helps prevent sunburn.
    • If used as directed with other sunscreen protection measures [see Directions], decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 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.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months: Ask a doctor.
    • Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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.

  • Inactive Ingredients

    WATER/EAU (AQUA), GLYCERIN, ETHYLHEXYL PALMITATE, CYCLOPENTASILOXANE, STEARLY ALCOHOL, POTASSIUM CETYL PHOSPHATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE. ALUMINA, BENZOIC ACID, BETA-SITOSTEROL, BHT, CAPRYLIC/CAPRIC TRIGYLCERIDE, CHLORPHENESIN, DISODIUM EDTA, GLYCINE SOJA (SOYBEAN) SEED EXTRACT ( GLYCINE SOJA SEED EXTRACT), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYDIMETHYL TAURATE COPOLYMER, PEG-32, PEG-400, PHENOXYETHANOL, 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.

  • Questions or comments?

    1-866-412-8363 (USA)

    www.aveneusa.com /

    1-877-41-2011 (CAN)

    www.eau-thermal-avene.ca

  • EAU THERMALE Avene Hydrance Optimale Hydrating Cream BROAD SPECTRUM SPF 25 40ml Carton Label

    EAU THERMALE Avene Hydrance Optimale Hydrating Cream BROAD SPECTRUM SPF 25 40ml Carton Label

  • INGREDIENTS AND APPEARANCE
    EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 
    octinoxate, octocrylene, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    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)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67015-0033-01 in 1 CARTON07/16/201804/30/2022
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/16/201804/30/2022
    Labeler - Pierre Fabre Dermo-Cosmetique USA, Inc. (117196928)
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