Label: INNISFREE DAILY UV DEFENSE SUNSCREEN- avobenzone, homosalate, and octisalate lotion lotion

  • NDC Code(s): 71220-082-09, 71220-082-10, 71220-082-36, 71220-082-37, view more
    71220-082-40
  • Packager: Innisfree Corporation
  • 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 September 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Avobenzone 2.5%

    Homosalate 7.0%

    Octisalate 4.3%

  • 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 causes by the sun
  • Warnings

    For external use only

    Do not use on damanged 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 product is 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, BUTYLENE GLYCOL, CYCLOPENTASILOXANE, BUTYLOCTYL SALICYLATE, ETHYLHEXYL METHOXYCRYLENE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, CETYL ALCOHOL, ARACHIDYL GLUCOSIDE, PHENOXYETHANOL, PROPANEDIOL, POLYACRYLATE CROSSPOLYMER-6, OCTYLDODECANOL, FRAGRANCE / PARFUM, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, T-BUTYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, CITRUS UNSHIU PEEL EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, ORCHID EXTRACT, CAMELLIA JAPONICA LEAF EXTRACT, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE

  • Other information

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

  • Questions?

    support@us.amorepacific.com

  • Innisfree Daily UV Defense

    innisfree

    Daily

    UV Defense

    Sunscreen

    Broad Spectrum SPF 36

    1.69 Fl. Oz. / 50 mL

    pdp 1

  • Innisfree Daily UV Defense - deluxe sample

    innisfree

    Daily

    UV Defense

    Sunscreen

    Broad Spectrum SPF 36

    0.33 Fl. Oz. / 10 mL

    11

    22

  • Innisfree Daily UV Defense - 100mL Jumbo

    Innisfree

    Daily

    UV Defense

    Sunscreen

    Broad Spectrum SPF 36

    3.38 Fl. Oz. /100 mL

    100mL

  • innisfree Daily UV Defense Sunscreen 50mL - limited edition

    innisfree

    Daily

    UV Defense

    Broad Spectrum SPF 36

    1.69 Fl. Oz. / 50 mL

    limited

  • innisfree Daily UV Defense Sunscreen 1mL - Blister Pack

    innisfree

    Daily UV Defense

    Sunscreen

    Braod Spectrum SPF 36

    0.03 Fl. Oz. / 1 mL

    blister pack

  • INGREDIENTS AND APPEARANCE
    INNISFREE DAILY UV DEFENSE SUNSCREEN 
    avobenzone, homosalate, and octisalate lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71220-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.5 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.15 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PURSLANE (UNII: M6S840WXG5)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TANGERINE PEEL (UNII: JU3D414057)  
    PHANERA VARIEGATA WHOLE (UNII: B11919964F)  
    CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71220-082-091 in 1 BOX03/01/2020
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71220-082-101 in 1 BOX05/01/202212/21/2023
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71220-082-361 in 1 BOX12/01/2021
    310 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:71220-082-371 mL in 1 BLISTER PACK; Type 0: Not a Combination Product12/17/202111/30/2023
    5NDC:71220-082-401 in 1 BOX01/01/2023
    5100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2020
    Labeler - Innisfree Corporation (557822425)
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