FDA.reportPublic FDA data

Laneige Hydro UV Defense

Manufacturer
Amorepacific Corporation
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:05

Label at a glance#

ProductLaneige Hydro UV Defense
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Indications and 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

Dosage and administration

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, especial...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Inactive ingredients

INACTIVE INGREDIENT SECTION


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

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

POSTMARKETING EXPERIENCE SECTION

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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. 1212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43419-768-082025-01-30C16284748780-12cef2736-b64a-d83d-e063-dadaa90ab31fLaneige Hydro UV Defense Broad Spectrum SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43419-768-08Laneige Hydro UV Defense1 in 1 CARTONLOTION12
43419-768-08Laneige Hydro UV Defense50 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43419-768LANEIGE HYDRO UV DEFENSE (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE LOTION) LOTION [AMOREPACIFIC CORPORATION]2Legacy NDC, 2 package rows20230111_c0f624a8-cd8a-cc50-e053-2995a90acb39.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 58 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-76843419-768-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL SALICYLATEWAO5MNK9TUIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
GERANIOLL837108USYIACT
OCTISALATE4X49Y0596WACTIB
PROPANEDIOL5965N8W85TIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
ZINC SULFATE89DS0H96TBIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
ALOE VERA LEAFZY81Z83H0XIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ABELMOSCHUS MOSCHATUS SEEDUN2QZ55I88IACT
POLYISOBUTYLENE (85000 MW)7X53O5S2ZYIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 207T1F30V5YHIACT
LAVENDER OILZBP1YXW0H8IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MANGANESE SULFATEW00LYS4T26IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
CYCLOMETHICONE 50THT5PCI0RIACT
C14-22 ALCOHOLSB1K89384RJIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
CENTELLA ASIATICA FLOWERING TOPJ02K2IV2PBIACT
BROCCOLI SPROUT128UH9LOAEIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f1ee6fef-bdbb-530e-e053-2a95a90a3159c0f624a8-cd8a-cc50-e053-2995a90acb392023-01-10WarningsExact identifier
spl id: f1ee6fef-bdbb-530e-e053-2a95a90a3159
spl set id: c0f624a8-cd8a-cc50-e053-2995a90acb39

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.