LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN- zinc oxide, octinoxate, and titanium dioxide lotion 
LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE- zinc oxide, octinoxate, and titanium dioxide lotion 
LANEIGE BB CUSHION HYDRA RADIANCE NO.23 SAND- zinc oxide, octinoxate, and titanium dioxide lotion 
LANEIGE BB CUSHION HYDRA RADIANCE NO.33 CINNAMON- zinc oxide, octinoxate, and titanium dioxide lotion 
LANEIGE BB CUSHION HYDRA RADIANCE NO.35 COFFEE- zinc oxide, octinoxate, and titanium dioxide lotion 
LANEIGE BB CUSHION HYDRA RADIANCE NO.37 CACAO- zinc oxide, octinoxate, and titanium dioxide 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.

----------

LANEIGE BB CUSHION HYDRA RADIANCE

Drug Facts

ACTIVE INGREDIENTS

OCTINOXATE 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.

OTHER INFORMATION

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

INACTIVE INGREDIENTS

WATER / AQUA / EAU, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891), PEG-10 DIMETHICONE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NIACINAMIDE, ACRYLATES /ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, IRON OXIDES (CI 77492), HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, FRAGRANCE / PARFUM, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, YEAST EXTRACT / FAEX / EXTRAIT DE LEVURE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77491), DIMETHICONE, TRIMETHYLSILOXYSILICATE, POLYSORBATE 80, DISODIUM EDTA, IRON OXIDES (CI 77499), HYDROGENATED LECITHIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, MICA (CI 77019), SILICA, 1,2-HEXANEDIOL, POLYPROPYLSILSESQUIOXANE, CHENOPODIUM QUINOA SEED EXTRACT, MAGNESIUM SULFATE, CALCIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, MANGANESE SULFATE, ZINC SULFATE, ASCORBYL GLUCOSIDE

QUESTIONS?

  • For US customers: support@us.amorepacific.com
  • For Canada customers: support@ca.amorepacific.com

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.11 Porcelain

LANEIGE

BB Cushion
Hydra Radiance

No.11 Porcelain

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. / 30 g (15 g x 2) e
DIN 02462273

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.11 Porcelain

PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.21 Beige

LANEIGE

TRAVEL EXCLUSIVE

BB Cushion Duo
Hydra Radiance

No.21 Beige

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. X 2 EA / 30 g (15 g x 2) X 2 EA e
DIN 02462273

PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.21 Beige

PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.23 Sand

LANEIGE

TRAVEL EXCLUSIVE

BB Cushion
Hydra Radiance Duo

No.23 Sand

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. X 2 EA / 30 g (15 g x 2) X 2 EA e
DIN 02462273

PRINCIPAL DISPLAY PANEL - x 2 (15 g x 2 Container Carton) Carton - No.23 Sand

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.33 Cinnamon

LANEIGE

BB Cushion
Hydra Radiance

No.33 Cinnamon

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. / 30 g (15 g x 2) e
DIN 02462273

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.33 Cinnamon

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.35 Coffee

LANEIGE

BB Cushion
Hydra Radiance

No.35 Coffee

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. / 30 g (15 g x 2) e
DIN 02462273

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.35 Coffee

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.37 Cacao

LANEIGE

BB Cushion
Hydra Radiance

No.37 Cacao

Broad Spectrum SPF 50+ Sunscreen

Net wt. 1.05 OZ. / 30 g (15 g x 2) e
DIN 02462273

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - No.37 Cacao
LANEIGE BB CUSHION HYDRA RADIANCE NO.11 PORCELAIN 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-751
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-751-312 in 1 CARTON12/26/201611/08/2021
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 FINALpart35212/26/201611/08/2021
LANEIGE BB CUSHION HYDRA RADIANCE NO.21 BEIGE 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-752
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-752-312 in 1 CARTON12/26/201601/10/2020
115 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:43419-752-362 in 1 CARTON12/26/201611/08/2021
2NDC:43419-752-312 in 1 CARTON
215 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 FINALpart35212/26/201611/08/2021
LANEIGE BB CUSHION HYDRA RADIANCE NO.23 SAND 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-753
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-753-312 in 1 CARTON12/26/201601/10/2020
115 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:43419-753-362 in 1 CARTON12/26/201611/08/2021
2NDC:43419-753-312 in 1 CARTON
215 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 FINALpart35212/26/201611/08/2021
LANEIGE BB CUSHION HYDRA RADIANCE NO.33 CINNAMON 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-754
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-754-312 in 1 CARTON12/26/201612/16/2021
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 FINALpart35212/26/201612/16/2021
LANEIGE BB CUSHION HYDRA RADIANCE NO.35 COFFEE 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-755
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-755-312 in 1 CARTON12/26/201604/18/2021
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 FINALpart35212/26/201604/18/2021
LANEIGE BB CUSHION HYDRA RADIANCE NO.37 CACAO 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-756
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MANGANESE SULFATE (UNII: W00LYS4T26)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-756-312 in 1 CARTON12/26/201604/09/2021
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 FINALpart35212/26/201604/09/2021
Labeler - Amorepacific Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Amorepacific Corporation694894112MANUFACTURE(43419-751, 43419-752, 43419-753, 43419-754, 43419-755, 43419-756)

Revised: 12/2019
Document Id: 9a10b949-db87-725a-e053-2995a90ab4e2
Set id: cf6c1c52-801f-4eb9-b0f9-2b9a56da4f84
Version: 5
Effective Time: 20191219
 
Amorepacific Corporation