LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50- octocrylene, homosalate, octisalate, avobenzone cream

LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by COSVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.5%

Homosalate 7%

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.

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

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

Inactive ingredients

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?

support@us.amorepacific.com

LANEIGE HYDRO UV DEFENSE EX

LANEIGE

HYDRO UV DEFENSE EX

SUNSCREEN

BROAD SPECTRUM SPF 50+

50 mL / 1.6 fl. oz.

INGREDIENTS AND APPEARANCE

LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 
octocrylene, homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71373-791
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
ABELMOSCHUS MOSCHATUS FLOWER (UNII: 599O6K8K81)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DOCOSANOL (UNII: 9G1OE216XY)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CENTELLA ASIATICA FLOWERING TOP (UNII: J02K2IV2PB)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MANGANESE SULFATE (UNII: W00LYS4T26)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71373-791-08	1 in 1 BOX	05/01/2024
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 Drug	M020	05/01/2024

Labeler - COSVISION (557789645)