LANEIGE NEO CUSHION MATTE 31W HONEY by Amorepacific Corporation LANEIGE NEO CUSHION

Drug Details [pdf]

LANEIGE NEO CUSHION MATTE 33C WALNUT- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 21N CUSTARD- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 23C ROSE BEIGE- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 33N HAZELNUT- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 17C MACADAMIA- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 23N CASHEW- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 13N VANILLA- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 21C ROSE- zinc oxide, octinoxate, and titanium dioxide lotion
LANEIGE NEO CUSHION MATTE 31W HONEY- zinc oxide, octinoxate, and titanium dioxide lotion
Amorepacific Corporation

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LANEIGE NEO CUSHION

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

PDP - LANEIGE NEO CUSHION MATTE 13N VANILLA [Refill]

LANEIGE NEO CUSHION_MATTE 13N VANILLA

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

refill 13

PDP - LANEIGE NEO CUSHION MATTE 17C MACADAMIA [REFILL]

LANEIGE NEO CUSHION MATTE 17C MACADAMIA

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

17 refill

PDP - LANEIGE NEO CUSHION MATTE 21N CUSTARD [REFILL]

LANEIGE NEO CUSHION_MATTE 21N CUSTARD

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

21N refill

PDP - LANEIGE NEO CUSHION MATTE 23N CASHEW [REFILL]

LANEIGE NEO CUSHION_MATTE 23N CASHEW

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

23N refill

PDP - LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE [REFILL]

LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

23C refill

PDP - LANEIGE NEO CUSHION MATTE 31W HONEY [REFILL]

LANEIGE NEO CUSHION_MATTE 31W HONEY

BROAD SPECTRUM SPF 42 PA++

[REFILL]

15g Net wt. 0.52 oz.

31W refill

PDP - LANEIGE NEO CUSHION_MATTE 21C ROSE [REFILL]

LANEIGE NEO CUSHION_MATTE 21C ROSE

BROAD SPECTRUM SPF 42 PA ++

[REFILL]

15g Net wt. 0.52 oz.

21c refill

PDP - LANEIGE NEO CUSHION MATTE 33C WALNUT [REFILL]

LANEIGE NEO CUSHION_MATTE 33C WALNUT

BROAD SPECTRUM SPF 42 PA++

[REFILL]

15g Net wt. 0.52 oz.

33c refill

PDP - LANEIGE NEO CUSHION MATTE 33N HAZELNUT [REFILL]

LANEIGE NEO CUSHION_MATTE 33N HAZELNUT

BROAD SPECTRUM SPF 42 PA++

[REFILL]

15g Net wt. 0.52 oz.

33N refill

PDP - LANEIGE NEO CUSHION_MATTE 13N VANILLA

LANEIGE NEO CUSHION_MATTE 13N VANILLA
BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

13N

PDP - LANEIGE NEO CUSHION_MATTE 17C MACADAMIA

LANEIGE NEO CUSHION_MATTE 13N VANILLA
BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

17C

PDP - LANEIGE NEO CUSHION_MATTE 21N CUSTARD

LANEIGE NEO CUSHION MATTE 21N CUSTARD

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

21N

PDP - LANEIGE NEO CUSHION_MATTE 21C ROSE

LANEIGE NEO CUSHION_MATTE 21C ROSE

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

21C

PDP - LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE

LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

23C

PDP - LANEIGE NEO CUSHION_MATTE 23N CASHEW

LANEIGE NEO CUSHION_MATTE 23N CASHEW

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

23N

PDP - LANEIGE NEO CUSHION_MATTE 31W HONEY

LANEIGE NEO CUSHION_MATTE 31W HONEY

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

31W

PDP - LANEIGE NEO CUSHION_MATTE 33C WALNUT

LANEIGE NEO CUSHION_MATTE 33C WALNUT

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

33C

PDP - LANEIGE NEO CUSHION_MATTE 33N HAZELNUT

LANEIGE NEO CUSHION_MATTE 33N HAZELNUT

BROAD SPECTRUM SPF 42 PA++

15 g X 2

Net wt. 0.52 oz. X 2

33N

LANEIGE NEO CUSHION MATTE 33C WALNUT
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-790
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-790-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-790-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 21N CUSTARD
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-784
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-784-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-784-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 23C ROSE BEIGE
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-787
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-787-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-787-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 33N HAZELNUT
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-789
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-789-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-789-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 17C MACADAMIA
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-783
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-783-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-783-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 23N CASHEW
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-786
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-786-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-786-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 13N VANILLA
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-782
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-782-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-782-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 21C ROSE
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-785
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-785-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-785-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

LANEIGE NEO CUSHION MATTE 31W HONEY
zinc oxide, octinoxate, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-788
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
NYLON-12 (UNII: 446U8J075B)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PROPANEDIOL (UNII: 5965N8W85T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 43419-788-34	1 in 1 BLISTER PACK	04/05/2023	10/01/2023
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-788-31	2 in 1 BOX	04/05/2023	10/01/2023
2		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 Drug	M020	04/05/2023	10/01/2023

Labeler - Amorepacific Corporation (631035289)

Name	Address	ID/FEI	Business Operations
Establishment
Amorepacific Corporation		694894112	manufacture(43419-782, 43419-783, 43419-784, 43419-785, 43419-786, 43419-787, 43419-788, 43419-789, 43419-790)

Revised: 11/2023

Document Id: 0b521905-680e-a034-e063-6394a90a0c26

Set id: ef44ae57-cc26-1d8f-e053-2995a90a0e47

Version: 2

Effective Time: 20231129

LANEIGE NEO CUSHION MATTE 31W HONEY by Amorepacific Corporation LANEIGE NEO CUSHION

LANEIGE NEO CUSHION MATTE 31W HONEY by

Drug Labeling and Warnings

Drug Details [pdf]

LANEIGE NEO CUSHION

Drug Facts

ACTIVE INGREDIENTS

PURPOSE

USES

WARNINGS

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

QUESTIONS?

PDP - LANEIGE NEO CUSHION MATTE 13N VANILLA [Refill]

PDP - LANEIGE NEO CUSHION MATTE 17C MACADAMIA [REFILL]

PDP - LANEIGE NEO CUSHION MATTE 21N CUSTARD [REFILL]

PDP - LANEIGE NEO CUSHION MATTE 23N CASHEW [REFILL]

PDP - LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE [REFILL]

PDP - LANEIGE NEO CUSHION MATTE 31W HONEY [REFILL]

PDP - LANEIGE NEO CUSHION_MATTE 21C ROSE [REFILL]

PDP - LANEIGE NEO CUSHION MATTE 33C WALNUT [REFILL]

PDP - LANEIGE NEO CUSHION MATTE 33N HAZELNUT [REFILL]

PDP - LANEIGE NEO CUSHION_MATTE 13N VANILLA

PDP - LANEIGE NEO CUSHION_MATTE 17C MACADAMIA

PDP - LANEIGE NEO CUSHION_MATTE 21N CUSTARD

PDP - LANEIGE NEO CUSHION_MATTE 21C ROSE

PDP - LANEIGE NEO CUSHION_MATTE 23C ROSE BEIGE

PDP - LANEIGE NEO CUSHION_MATTE 23N CASHEW

PDP - LANEIGE NEO CUSHION_MATTE 31W HONEY

PDP - LANEIGE NEO CUSHION_MATTE 33C WALNUT

PDP - LANEIGE NEO CUSHION_MATTE 33N HAZELNUT