LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50

Manufacturer
AMOREPACIFIC CORPORATION
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:10

Label at a glance#

ProductLANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50
Active ingredientHOMOSALATE, AVOBENZONE, OCTOCRYLENE, OCTISALATE
Label structure9 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. Children under 6 months of age: Ask a doctor. 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 rick 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 meas...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - PURPOSE SECTION

Avobenzone 2.5%

Homosalate 7%

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.

Children under 6 months of age: Ask a doctor.

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 rick 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

TROUBLESHOOTING

support@us.amorepacific.com

LANEIGE HYDRO UV DEFENSE EX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LANEIGE

HYDRO UV DEFENSE EX

SUNSCREEN

BROAD SPECTRUM SPF 50+

50 mL / 1.6 fl. oz. pdppdp

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43419-791-08LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 5050 mL in 1 TUBECREAM502
43419-791-08LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 501 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43419-791LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) CREAM [AMOREPACIFIC CORPORATION]2Current NDC, 2 package rows20241010_0e746836-ed84-7b33-e063-6294a90aeff3.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-79143419-791-08

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

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
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0e746836-ed84-7b33-e063-6294a90aeff32024-10-08WarningsExact identifier
ndc (package): 43419-791-08
ndc (product): 43419-791
ndc11 (package): 43419079108
spl id: 23f95123-0659-d024-e063-6294a90a9875
spl set id: 0e746836-ed84-7b33-e063-6294a90aeff3

Reported adverse events (FAERS/openFDA)#

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