EAU THERMALE AVENE MINERAL SUNSCREEN FLUID SPF 50 PLUS (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]

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  • EAU THERMALE AVENE MINERAL SUNSCREEN FLUID SPF 50 PLUS (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]

EAU THERMALE AVENE MINERAL SUNSCREEN FLUID SPF 50 PLUS (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [PIERRE FABRE USA INC.]
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NDC 67015-0864-1
Set ID 87eb6adc-c3d1-d7df-e053-2a95a90aa747
Category HUMAN OTC DRUG LABEL
Packager Pierre Fabre USA Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 11.42%

    Zinc Oxide 14.6%

  • 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


    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse eyes 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

    • Shake well before use
    • Apply liberally 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 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-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    WATER, COCO-CAPRYLATE/CAPRATE, ISOCETYL STEAROYL STEARATE, ISOPROPYL PALMITATE, ISODECYL NEOPENTANOATE, ISODODECANE, ISOHEXADECANE, PTFE, TRIETHYLHEXANOIN, DICAPRYLYL ETHER, PEG-30 DIPOLYHYDROXYSTEARATE, ALUMINA, STEARIC ACID, CAPRYLYL GLYCOL, PEG-45/DODECYL GLYCOL COPOLYMER, SILICA, BENZOIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, DISODIUM EDTA, DISTEARDIMONIUM HECTORITE, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, POLYAMIDE-3, SODIUM CHLORIDE, TOCOPHEROL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE.

  • Questions or comments?

     visit www.aveneusa.com or call toll-free 1-866-41-AVENE (28363)

  • Principal Display Panel - 40 mL Carton

    EAU THERMALE

    Avene

    VERY HIGH PROTECTION

    Broad spectrum SPF 50+

    Water resistant (80 minutes)

    Chemical filter-free

    Antioxidant

    SPF 50+ UVB/UVA

    Mineral

    Sunscreen Fluid

    FRAGRANCE-FREE

    For sensitive skin, intolerant skin

    PARIS

    1.35 FL. OZ. (40 mL)

    Avene Mineral Sunscreen Fluid SPF 50 Plus

  • INGREDIENTS AND APPEARANCE
    EAU THERMALE AVENE MINERAL SUNSCREEN FLUID SPF 50 PLUS 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-0864
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE114 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE146 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEG-45/DODECYL GLYCOL COPOLYMER (UNII: 9H0V8CHB0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ISODODECANE (UNII: A8289P68Y2)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67015-0864-11 in 1 CARTON05/02/2019
    140 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/02/201903/31/2022
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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