Label: GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate lotion

  • NDC Code(s): 68577-152-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 24, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone 3%

    Homosalate 6%

    Octisalate 5%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    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 cause by the sun
  • Warnings

    Warnings

    For extenal use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Directions

    • apply generously 15 minutes before sun exposure
    • 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-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients:Water, Butyloctyl Salicylate, Dipropylene Glycol, Methyl Trimethicone,
    Biosaccharide Gum-4, Caprylyl Methicone, Propanediol, Bis-Ethylhexyl
    Hydroxydimethoxy Benzylmalonate, Betaine, Acrylates Copolymer,
    Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone,
    Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Dibutyl
    Lauroyl Glutamide, Dibutyl Ethylhexanoyl Glutamide, Citrus Aurantium
    Dulcis (Orange) Peel Oil, Dipotassium Glycyrrhizate, Carbomer, Tocopheryl
    Acetate, Aminomethyl Propanol, Butylene Glycol, Hippophae Rhamnoides
    Fruit Extract, Disodium EDTA, Pentylene Glycol, Aloe Barbadensis Leaf
    Extract, Silica, Bioflavonoids, Potassium Sorbate, Hydroxyphenyl
    Propamidobenzoic Acid, Brassica Oleracea Italica (Broccoli) Extract,
    Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate.

  • OTHER INFORMATION

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • QUESTIONS or COMMENTS

    Questions or comments?

    visit www.glossier.com or call toll-free
    1-844-OK-GTEAM 1-844-654-8326

  • PRINCIPAL DISPLAY PANEL

    Primary Packaging

    Primary Package

  • PRINCIPAL DISPLAY PANEL

    Secondary Package

    Outer Carton

  • INGREDIENTS AND APPEARANCE
    GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)  
    BETAINE (UNII: 3SCV180C9W)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-152-011 in 1 CARTON06/01/2023
    130 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2023
    Labeler - COSMAX USA, CORPORATION (010990210)
    Registrant - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-152)
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