Label: GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 9, 2017

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 6%

    Octisalate 5%

  • 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 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 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 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

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

  • Questions or Comments?

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

  • Principal Display Panel

    71425-010-30

  • INGREDIENTS AND APPEARANCE
    GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 
    glossier invisible shield daily sunscreen broad spectrum spf 35 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71425-010
    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) HOMOSALATE6 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    BRASSICA OLERACEA VAR. BOTRYTIS WHOLE (UNII: 87M72T7VW1)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71425-010-301 in 1 CARTON05/09/2017
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/09/2017
    Labeler - Glossier Inc. (078541007)
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