LANEIGE BB CUSHION LIGHT- octinoxate, titanium dioxide, and zinc oxide lotion 
LANEIGE BB CUSHION MEDIUM- octinoxate, titanium dioxide, and zinc oxide lotion 
LANEIGE BB CUSHION DARK- octinoxate, titanium dioxide, and zinc oxide lotion 
LANEIGE BB CUSHION MEDIUM DARK- octinoxate, titanium dioxide, and zinc oxide lotion 
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 BB Cushion

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXIDE 9.8%

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, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PEG-10 DIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ARBUTIN, BUTYLENE GLYCOL, TITANIUM DIOXIDE (CI 77891), CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, MANGANESE SULFATE, ZINC SULFATE, MAGNESIUM SULFATE, MELIA AZADIRACHTA EXTRACT, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYMETHYLMETHACRYLATE, POLYHYDROXYSTEARIC ACID, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, LECITHIN, ETHYLHEXYL PALMITATE, ISOSTEARIC ACID, ISOPROPYL PALMITATE, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYLHEXYLGLYCERIN, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, TRIMETHYLSILOXYSILICATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, SODIUM CHLORIDE, PHENOXYETHANOL, DISODIUM EDTA, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), FRAGRANCE

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton - Light

LANEIGE

BB Cushion Light
SPF 50+
Broad Spectrum
Sunscreen

Protects• Covers• Hydrates• Soothes• Brightens.
for all skin

Net wt. 1.05 OZ.e/ 30 g (15 g x 2)

Principal Display Panel - 30 g Jar Carton - Light

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton - Medium

LANEIGE

BB Cushion Medium
SPF 50+
Broad Spectrum
Sunscreen

Protects• Covers• Hydrates• Soothes• Brightens.
for all skin

Net wt. 1.05 OZ.e/ 30 g (15 g x 2)

Principal Display Panel - 30 g Jar Carton - Medium

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton - Dark

LANEIGE

BB Cushion Dark
SPF 50+
Broad Spectrum
Sunscreen

Protects• Covers• Hydrates• Soothes• Brightens.
for all skin

Net wt. 1.05 OZ.e/ 30 g (15 g x 2)

Principal Display Panel - 30 g Jar Carton - Dark

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton - Medium Dark

LANEIGE

BB Cushion Medium Dark
SPF 50+
Broad Spectrum
Sunscreen

Protects• Covers• Hydrates• Soothes• Brightens.
for all skin

Net wt. 1.05 OZ.e/ 30 g (15 g x 2)

Principal Display Panel - 30 g Jar Carton - Medium Dark
LANEIGE BB CUSHION LIGHT 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-704
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ARBUTIN (UNII: C5INA23HXF)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AZADIRACHTA INDICA SEED (UNII: P1NV46V59R)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-704-212 in 1 CARTON10/30/201407/31/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/30/201407/31/2018
LANEIGE BB CUSHION MEDIUM 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-705
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ARBUTIN (UNII: C5INA23HXF)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AZADIRACHTA INDICA SEED (UNII: P1NV46V59R)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-705-212 in 1 CARTON10/30/201407/31/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/30/201407/31/2018
LANEIGE BB CUSHION DARK 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-706
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ARBUTIN (UNII: C5INA23HXF)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
AZADIRACHTA INDICA SEED (UNII: P1NV46V59R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-706-212 in 1 CARTON10/30/201407/31/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/30/201407/31/2018
LANEIGE BB CUSHION MEDIUM DARK 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ARBUTIN (UNII: C5INA23HXF)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
AZADIRACHTA INDICA SEED (UNII: P1NV46V59R)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-733-212 in 1 CARTON10/30/201407/31/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/30/201407/31/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)

Revised: 8/2018
 
AMOREPACIFIC CORPORATION