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

Laneige Hydro UV Defense by

Drug Labeling and Warnings

Laneige Hydro UV Defense by is a Otc medication manufactured, distributed, or labeled by Amorepacific Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

LANEIGE HYDRO UV DEFENSE 
avobenzone, homosalate, octisalate, and octocrylene lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-768
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-768-08	1 in 1 CARTON	12/31/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/31/2021

Labeler - Amorepacific Corporation (631035289)