LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.11 PORCELAIN- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.21 BEIGE- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.23 SAND- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.33 CINNAMON- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.35 COFFEE- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS 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 Limited Edition with Crystals

Drug Facts

ACTIVE INGREDIENTS W/W

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.

OTHER INFORMATION

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

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

AQUA/WATER/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, FAEX/YEAST EXTRACT/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 GLUCOSID

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

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.11 Porcelain

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.11 Porcelain

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - No.21 Beige

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.21 Beige

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.21 Beige

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - No.23 Sand

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.23 Sand

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.23 Sand

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

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.33 Cinnamon

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.33 Cinnamon

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

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.35 Coffee

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.35 Coffee

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

LANEIGE

BB Cushion Hydra Radiance
Limited Edition with Crystals
from Swarovski ®

No.37 Cacao

Broad Spectrum SPF 50+ Sunscreen

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

Principal Display Panel - 15 g Container Carton - No.37 Cacao

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.11 PORCELAIN
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-761
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-761-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.21 BEIGE
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-762
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-762-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.23 SAND
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-763
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-763-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.33 CINNAMON
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-764
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-764-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.35 COFFEE
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-766
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-766-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

LANEIGE BB CUSHION HYDRA RADIANCE LIMITED EDITION WITH CRYSTALS NO.37 CACAO
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-767
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-767-31	2 in 1 CARTON	03/22/2018	09/30/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/20/2018	04/30/2019

Labeler - Amorepacific Corporation (631035289)

Name	Address	ID/FEI	Business Operations
Establishment
Amorepacific Corporation		694894112	manufacture(43419-761, 43419-762, 43419-763, 43419-764, 43419-766, 43419-767)

Revised: 11/2018

Document Id: 7a3ecbae-9f6a-3719-e053-2a91aa0ac277

Set id: fb67b7c3-7cdf-4def-beb5-62dd6aafad50

Version: 3

Effective Time: 20181109

Amorepacific Corporation