LANEIGE TRIPLE SUNSCREEN- avobenzone, octisalate, homosalate, and octocrylene cream 
AMOREPACIFIC CORPORATION

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.

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Laneige Triple Sunscreen

Drug Facts

ACTIVE INGREDIENTS

BUTYL METHOXYDIBENZOYLMETHANE 3%
ETHYLHEXYL SALICYLATE 4.5%
HOMOSALATE 9%
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 product is 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

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, ALTHAEA OFFICINALIS ROOT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, CENTELLA ASIATICA EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CHENOPODIUM QUINOA SEED EXTRACT, MAGNESIUM SULFATE, MANGANESE SULFATE, ZINC SULFATE, CALCIUM CHLORIDE, SILICA, BEHENYL ALCOHOL, C14-22 ALCOHOLS, GLYCERYL STEARATE, PEG-100 STEARATE, POLYACRYLATE-13, POLYISOBUTENE, C12-20 ALKYL GLUCOSIDE, POLYSORBATE 20, ASCORBYL GLUCOSIDE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, PHENOXYETHANOL, FRAGRANCE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL 50 mL Tube Carton

LANEIGE

Triple
Sunscreen

SPF 40
Multi-Action
Broad Spectrum
Sun Protector

for all skin

50 mL / 1.6 FL.OZ. e

PRINCIPAL DISPLAY PANEL 50 mL Tube Carton
LANEIGE TRIPLE SUNSCREEN 
avobenzone, octisalate, homosalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-765
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1500 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2250 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4500 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4500 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
ALOYSIA CITRODORA LEAF (UNII: 9B1F4HKA9O)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DOCOSANOL (UNII: 9G1OE216XY)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-765-011 in 1 CARTON11/20/201412/31/2018
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/20/201412/31/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-765)

Revised: 9/2019
Document Id: 91d2568b-8b44-e0b1-e053-2995a90a5675
Set id: c92ab0c0-a092-4d72-807f-6ebe0d19cbe4
Version: 3
Effective Time: 20190905
 
AMOREPACIFIC CORPORATION