LANEIGE CUSHION CONCEALER NO.11 ROSE PORCELAIN- octinoxate, titanium dioxide, and zinc oxide lotion LANEIGE CUSHION CONCEALER NO.13 COOL IVORY- octinoxate, titanium dioxide, and zinc oxide lotion LANEIGE CUSHION CONCEALER NO.21 COOL BEIGE- octinoxate, titanium dioxide, and zinc oxide lotion LANEIGE CUSHION CONCEALER NO.23 SAND- octinoxate, titanium dioxide, and zinc oxide lotion

LANEIGE CUSHION CONCEALER No.23 Sand by

Drug Labeling and Warnings

LANEIGE CUSHION CONCEALER No.23 Sand by is a Otc medication manufactured, distributed, or labeled by Amorepacific Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENTS W/W

OCTINOXATE 5%

TITANIUM DIOXIDE 2.49%

ZINC OXIDE 1.96%

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, TITANIUM DIOXIDE (CI 77891), PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, POLYGLYCERYL-2 TRIISOSTEARATE, METHYL METHACRYLATE CROSSPOLYMER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, POLYPROPYLSILSESQUIOXANE, SODIUM CHLORIDE, SORBITAN ISOSTEARATE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77492), ALUMINUM HYDROXIDE, DISTEARDIMONIUM HECTORITE, OZOKERITE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491), FRAGRANCE/PARFUM, STEARIC ACID, CAPRYLYL GLYCOL, IRON OXIDES (CI 77499), DISODIUM EDTA

PRINCIPAL DISPLAY PANEL - 2.5 mL Container Carton - No.11 Rose Porcelain

LANEIGE

Cushion
Concealer

No.11
Rose
Porcelain

Broad Spectrum
SPF 37 Sunscreen

2.5 mL / 0.08 FL. OZ. e
DIN 02462281

PRINCIPAL DISPLAY PANEL - 2.5 mL Container Carton - No.13 Cool Ivory

LANEIGE

Cushion
Concealer

No.13
Cool
Ivory

Broad Spectrum
SPF 37 Sunscreen

2.5 mL / 0.08 FL. OZ. e
DIN 02462281

PRINCIPAL DISPLAY PANEL - 2.5 mL Container Carton - No.21 Cool Beige

LANEIGE

Cushion
Concealer

No.21
Cool
Beige

Broad Spectrum
SPF 37 Sunscreen

2.5 mL / 0.08 FL. OZ. e
DIN 02462281

PRINCIPAL DISPLAY PANEL - 2.5 mL Container Carton - No.23 Sand

LANEIGE

Cushion
Concealer

No.23
Sand

Broad Spectrum
SPF 37 Sunscreen

2.5 mL / 0.08 FL. OZ. e
DIN 02462281

INGREDIENTS AND APPEARANCE

LANEIGE CUSHION CONCEALER NO.11 ROSE PORCELAIN 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-757
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	125 mg  in 2.5 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62.25 mg  in 2.5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-757-29	1 in 1 CARTON	12/26/2016	06/29/2020
1		2.5 mL in 1 CONTAINER; 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	12/26/2016	06/29/2020

LANEIGE CUSHION CONCEALER NO.13 COOL IVORY 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-758
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	125 mg  in 2.5 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62.25 mg  in 2.5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-758-29	1 in 1 CARTON	12/26/2016	10/10/2020
1		2.5 mL in 1 CONTAINER; 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	12/26/2016	10/10/2020

LANEIGE CUSHION CONCEALER NO.21 COOL BEIGE 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-759
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	125 mg  in 2.5 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62.25 mg  in 2.5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-759-29	1 in 1 CARTON	12/26/2016	09/19/2020
1		2.5 mL in 1 CONTAINER; 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	12/26/2016	09/19/2020

LANEIGE CUSHION CONCEALER NO.23 SAND 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-760
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	125 mg  in 2.5 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62.25 mg  in 2.5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-760-29	1 in 1 CARTON	12/26/2016	06/13/2021
1		2.5 mL in 1 CONTAINER; 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	12/26/2016	06/13/2021

Labeler - Amorepacific Corporation (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
Amorepacific Corporation		694894112	manufacture(43419-757, 43419-758, 43419-759, 43419-760)