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
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
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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
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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?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LANEIGE HYDRO UV DEFENSE
avobenzone, homosalate, octisalate, and octocrylene lotion lotionProduct 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)