Label: INNISFREE MATTE PRIMING UV SHIELD SUNSCREEN- octisalate, titanium dioxide, and octocrylene lotion lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Octisalate 4.0%

    Titanium Dioxide 3.5%

    Octocrylene 2.5%

  • 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
    • 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 / AQUA / EAU, DIMETHICONE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PROPYLHEPTYL CAPRYLATE, CETYL PEG/PPG-10/1 DIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPANEDIOL, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SYNTHETIC FLUORPHLOGOPITE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, 1,2-HEXANEDIOL, MAGNESIUM SULFATE, POLYHYDROXYSTEARIC ACID, METHYL METHACRYLATE CROSSPOLYMER, ALUMINA, FRAGRANCE / PARFUM, STEARIC ACID, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, SOLIDAGO VIRGAUREA (GOLDENROD) EXTRACT, EUGENIA CARYOPHYLLUS (CLOVE) BUD EXTRACT, ETHYLHEXYLGLYCERIN, DICAPRYLYL CARBONATE, MICA, SILICA, TOCOPHEROL, IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE

  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun
  • Questions?

    support@us.amorepacific.com

  • PRINCIPAL DISPLAY PANEL

    Innisfree

    Gentle Care

    for Sensitive Skin

    Sunscreen

    Braod Spectrum SPF 29

    40 mL / 1.35 Fl. Oz.

    1

    2

  • INGREDIENTS AND APPEARANCE
    INNISFREE MATTE PRIMING UV SHIELD SUNSCREEN 
    octisalate, titanium dioxide, and octocrylene lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71220-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.25 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SOLIDAGO VIRGAUREA WHOLE (UNII: F45YHM06JE)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CLOVE (UNII: K48IKT5321)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71220-083-091 in 1 CARTON06/15/202005/04/2025
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/15/202005/04/2025
    Labeler - Innisfree Corporation (557822425)
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