Label: GLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MIN aerosol, spray

  • Category: HUMAN OTC DRUG LABEL

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 13, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Avobenzone 2.1%
    Homosalate 10.50%
    Octisalate 3.50%
    Octocrylene 7.00%

  • 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
    Flammable: Contents under pressure. Do not puncture or incinerate.
    Do not store at temperature above 120°F. Use only as directed. Intentional
    misuse by deliberately con-centrating and inhaling the contents can be
    harmful or fatal. Keep out of reach of children.
    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 docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 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
    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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Alcohol Denat., Isobutane, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Caprylyl Methicone, Parfum/Fragrance, Acrylates/Octylacrylamide Copolymer, Mica, Dibutyl Adipate, Tocopheryl Acetate, Ascorbyl Palmitate, Mauritia Flexuosa Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Mimosa Tenuiflora Bark Extract, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).

  • Other Information

    • protect the product in this container from excessive
    heat and direct sun

  • Questions or Comments?

    visit Glossier.com, email us at gTEAM@glossier.com,
    or call toll-free 1-844-654-8326

  • Principal Display Panel

    71425-030-06

  • INGREDIENTS AND APPEARANCE
    GLOSSIER SUN GLAZE GLEAMING SUNSCREEN OIL BROAD SPECTRUM SPF 30 WATER RESISTANT 40 MIN 
    glossier sun glaze gleaming sunscreen oil broad spectrum spf 30 water resistant 40 min aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71425-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    MICA (UNII: V8A1AW0880)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71425-030-061 in 1 PACKAGE01/01/2019
    1167 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2019
    Labeler - Glossier Inc. (078541007)