Label: LANEIGE HYDRO UV DEFENSE- avobenzone, homosalate, octisalate, and octocrylene lotion lotion

  • NDC Code(s): 43419-768-08
  • Packager: Amorepacific 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 January 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Inactive ingredients


    WATER / AQUA / EAU, PROPANEDIOL, BUTYLOCTYL SALICYLATE, GLYCERIN, DIMETHICONE, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, TRISILOXANE, VP/EICOSENE COPOLYMER, CYCLOPENTASILOXANE, TRIMETHYLSILOXYSILICATE, C14-22 ALCOHOLS, 1,2-HEXANEDIOL, GLYCERYLSTEARATE, PEG-100 STEARATE, PHENYL TRIMETHICONE, CETYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, CAPRYLYL METHICONE, POLYACRYLATE-13, FRAGRANCE / PARFUM, POLYISOBUTENE, C12-20 ALKYL GLUCOSIDE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYSORBATE 20, SORBITAN ISOSTEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, BUTYLPHENYL METHYLPROPIONAL, HYDROXYCITRONELLAL, LIMONENE, BENZYL SALICYLATE, ALPHA-ISOMETHYL IONONE, GERANIOL, CITRONELLOL, BUTYLENE GLYCOL, GLUCOSE, ALOE BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, CENTELLA ASIATICA FLOWER/LEAF/STEM EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, HIBISCUS ABELMOSCHUS EXTRACT, MAGNESIUM SULFATE, CALCIUM CHLORIDE, TOCOPHEROL, XANTHAN GUM, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, MANGANESE SULFATE, CHENOPODIUM QUINOA SEED EXTRACT, ZINC SULFATE, ASCORBYL GLUCOSIDE

  • ACTIVE INGREDIENTS

    Avobenzone 2.5%
    Homosalate 9%
    Octisalate 4.5%
    Octocrylene 9%

  • 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.
  • OTHER INFORMATION

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

  • Questions?

    support@us.amorepacific.com

  • PRINCIPAL DISPLAY PANEL

    Laneige

    Hydro UV Defense

    Sunscreen

    Broad Spectrum

    SPF 50+

    Hypoallergenic Tested

    Dermatologist Tested

    No White Cast

    50 ml / 1.6 fl. oz. 12

  • INGREDIENTS AND APPEARANCE
    LANEIGE HYDRO UV DEFENSE 
    avobenzone, homosalate, octisalate, and octocrylene lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-768
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    GERANIOL (UNII: L837108USY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)  
    POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MANGANESE SULFATE (UNII: W00LYS4T26)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CENTELLA ASIATICA FLOWERING TOP (UNII: J02K2IV2PB)  
    BROCCOLI SPROUT (UNII: 128UH9LOAE)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-768-081 in 1 CARTON12/31/2021
    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 not finalpart35212/31/2021
    Labeler - Amorepacific Corporation (631035289)
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