Label: AVENE SOLAIRE UV MINERAL SUNSCREEN SPF 50 PLUS- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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

  • Drug Facts

  • Purpose

    Sunscreen

  • Active Ingredient

    Zinc Oxide 12%

  • 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 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 dry.

    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 of skin cancer and early skin gaining. 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 to 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

    AVÈNE THERMAL SPRING WATER, C12-15 ALKYL BENZOATE,
    CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS,
    TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4
    DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NYLON-12,
    NIACINAMIDE, METHYLPROPANEDIOL, COCO-CAPRYLATE, SILICA,
    SODIUM CHLORIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,
    CAPRYLYL GLYCOL, BISABOLOL, ALLANTOIN, ORYZA SATIVA (RICE)
    BRAN EXTRACT, LECITHIN, PHENYLPROPANOL, HELIANTHUS
    ANNUUS (SUNFLOWER) EXTRACT, TOCOPHEROL, ROSMARINUS
    OFFICINALIS (ROSEMARY) LEAF EXTRACT, TETRASODIUM
    GLUTAMATE DIACETATE, ISOSTEARIC ACID, 1,2-HEXANEDIOL,
    SODIUM HYDROXIDE

  • Questions or comments?

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

  • Principal Display Panel - 50 mL Carton

    EAU THERMALE

    Avene

    SPF 50+

    Broad Spectrum

    Solaire UV

    Mineral Multi-Defense

    Sunscreen Fluid

    Fragrance-Free

    Oil-Free

    40-Minute Water Resistance

    Sheer, Non-Whitening

    For Sensitive Skin

    50 ml/1.7 FL. OZ.

    Avene Multi Defense Sunscreen Fluid Carton 50ml

  • INGREDIENTS AND APPEARANCE
    AVENE SOLAIRE UV MINERAL SUNSCREEN  SPF 50 PLUS
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-724
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    JOJOBA OIL (UNII: 724GKU717M)  
    METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
    NYLON-12 (UNII: 446U8J075B)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-724-011 in 1 CARTON05/17/2021
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/17/202111/06/2025
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)