Label: AVAIL FACIAL SUNSCREEN SPF 25- homosalate, octocrylene, octisalate, avobenzone lotion

  • NDC Code(s): 76293-055-01, 76293-055-02
  • Packager: Emeis Cosmetics Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 12, 2020

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

  • Drug Facts

  • Active ingredients

    Avobenzone 3%

    Homosalate 9%

    Octisalate 4%

    Octocrylene 7%

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months: Ask a doctor.

    Reapply

    • At least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.

    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 value 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.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
    • You may report a serious adverse reaction to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.
  • Inactive ingredients

    Water (Aqua), Coco-Caprylate, Tribehenin PEG-20 Esters, Glycerin, Silica, Squalane, Phenoxyethanol, Ethylhexylglycerin, Benzyl Alcohol, Tocopheryl Acetate, Tocopherol, Glycine Soja (Soybean) Oil, Panthenol, Lavandula Angustifolia (Lavender) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Sodium Dehydroacetate, Cedrus Atlantica (Cedarwood) Bark Oil, Sodium Hydroxide, Cellulose Gum, Sodium Carrageenan, Camellia Sinensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Sea Salt (Maris sal), Lactic Acid, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Linalool, Limonene, Geraniol.

  • Company information

    Aesop, 25 Smith Street, Fitzroy 3065, Australia.

    +61 3 9412 8900

    aesop@aesop.com

    Aesop USA Inc, 48 West 25th St, New York, NY, 10010

  • Product Packaging - 50.8g

    Aēsop

    Avail Facial Lotion with Sunscreen SPF 25

    Green Tea · Panthenol · Tocopherol

    Broad-spectrum SPF 25 sunscreen lotion for daily use.

    Massage generously into uncovered skin fifteen minutes prior to sun exposure. Reapply every two hours. Use water-resistant sunscreen if swimming or sweating.

    www.aesop.com

    Net wt. 50.8g/1.79Oz.

    avail face

  • INGREDIENTS AND APPEARANCE
    AVAIL FACIAL SUNSCREEN SPF 25 
    homosalate, octocrylene, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76293-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID, L- (UNII: F9S9FFU82N)  
    SEA SALT (UNII: 87GE52P74G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    GERANIOL (UNII: L837108USY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CARROT (UNII: L56Z1JK48B)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    WATER (UNII: 059QF0KO0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Product Characteristics
    Colorwhite (Off-white to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76293-055-011 in 1 CARTON01/01/2019
    150.8 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:76293-055-021 in 1 CARTON01/01/2019
    25 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2019
    Labeler - Emeis Cosmetics Pty Ltd (754271146)