Label: AVENE SOLAIRE UV TINTED 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.

View All Sections
  • Drug Facts

  • Active ingredient

    Zinc Oxide 12%

  • 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 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 40 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 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

    WATER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS, TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NIACINAMIDE, NYLON-12, METHYLPROPANEDIOL, COCO-CAPRYLATE, IRON OXIDES, SILICA, AVENE THERMAL SPRING WATER, 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, HYDROGENATED LECITHIN,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+

    UVA/UVB

    Broad Spectrum SPF 50+

    Solaire UV

    Mineral Multi-Defense

    Tinted Sunscreen Fluid

    Fragrance-Free • Oil-Free

    Water Resistant (40-Minute)

    Sheer, Natural Finish

    Sensitive Skin

    50 ml/1.7 FL. OZ.

    Pierre Fabre

    Dermo-Cosmetique

    Laboratoires Dermatologiques Avène
    45, place Abel-Gance
    92100 Boulogne - Paris - France
    Les Cauquillous - 81500 Lavaur - France
    Distributed by:
    Pierre Fabre USA Inc
    Parsippany, NJ 07054

    label

  • INGREDIENTS AND APPEARANCE
    AVENE SOLAIRE UV TINTED MINERAL SUNSCREEN  SPF 50 PLUS
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-725
    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
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
    NYLON-12 (UNII: 446U8J075B)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-725-011 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!