SULWHASOO PERFECTING CUSHION NO.21- octinoxate, titanium dioxide, and zinc oxide sponge SULWHASOO PERFECTING CUSHION NO.23- octinoxate, titanium dioxide, and zinc oxide sponge SULWHASOO PERFECTING CUSHION NO.25- octinoxate, titanium dioxide, and zinc oxide sponge

SULWHASOO PERFECTING CUSHION NO.25 by

Drug Labeling and Warnings

SULWHASOO PERFECTING CUSHION NO.25 by is a Otc medication manufactured, distributed, or labeled by Amorepacific Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

AQUA/WATER/EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, ZINC OXIDE (CI 77947), ETHYLHEXYL METHOXYCINNAMATE, PHENYL TRIMETHICONE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, POLYPROPYLSILSESQUIOXANE, STEARIC ACID, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, GLYCERIN, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POLYGLYCERYL-3 POLYRICINOLEATE, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, NELUMBO NUCIFERA SEED EXTRACT, HYDROGENATED LECITHIN, ETHYLHEXYLGLYCERIN, ACRYLATES/ STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYMETHYLSILSESQUIOXANE, MICA (CI 77019), SILICA, ALCOHOL, SQUALANE, DIMETHICONE, TRIMETHYLSILOXYSILICATE, DISODIUM EDTA, ADENOSINE, MEL/HONEY/MIEL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM HYALURONATE, PINUS KORAIENSIS SEED OIL, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, SESAMUM INDICUM (SESAME) SEED OIL, CAMELLIA JAPONICA SEED OIL, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, ALUMINA, PRUNUS PERSICA (PEACH) KERNEL EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, PRUNUS MUME FRUIT EXTRACT, MEL/HONEY EXTRACT/EXTRAIT DE MIEL, NELUMBO NUCIFERA GERM EXTRACT, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), FRAGRANCE/PARFUM

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 21

Sulwhasoo

PERFECTING CUSHION

NO. 21

BROAD SPECTRUM
SPF50+
SUNSCREEN

MEDIUM PINK

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

DIN : 02445263

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 23

Sulwhasoo

PERFECTING CUSHION

NO. 23

BROAD SPECTRUM
SPF50+
SUNSCREEN

MEDIUM BEIGE

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

DIN : 02445263

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 25

Sulwhasoo

PERFECTING CUSHION

NO. 25

BROAD SPECTRUM
SPF50+
SUNSCREEN

DEEP BEIGE

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

DIN : 02445263

INGREDIENTS AND APPEARANCE

SULWHASOO PERFECTING CUSHION NO.21 
octinoxate, titanium dioxide, and zinc oxide sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ARBUTIN (UNII: C5INA23HXF)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
HONEY (UNII: Y9H1V576FH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)
SESAME OIL (UNII: QX10HYY4QV)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
PRUNUS PERSICA SEED (UNII: V9C81470RR)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
NELUMBO NUCIFERA GERM (UNII: 3KNW4B421S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-051-31	2 in 1 CARTON	11/05/2018	05/31/2021
1		15 g 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	09/02/2015	05/31/2021

SULWHASOO PERFECTING CUSHION NO.23 
octinoxate, titanium dioxide, and zinc oxide sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ARBUTIN (UNII: C5INA23HXF)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SQUALANE (UNII: GW89575KF9)
HONEY (UNII: Y9H1V576FH)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)
SESAME OIL (UNII: QX10HYY4QV)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
PRUNUS PERSICA SEED (UNII: V9C81470RR)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
NELUMBO NUCIFERA GERM (UNII: 3KNW4B421S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-052-31	2 in 1 CARTON	11/05/2018	05/31/2021
1		15 g 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	09/02/2015	05/31/2021

SULWHASOO PERFECTING CUSHION NO.25 
octinoxate, titanium dioxide, and zinc oxide sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ARBUTIN (UNII: C5INA23HXF)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
HONEY (UNII: Y9H1V576FH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)
SESAME OIL (UNII: QX10HYY4QV)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
PRUNUS PERSICA SEED (UNII: V9C81470RR)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
NELUMBO NUCIFERA GERM (UNII: 3KNW4B421S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-053-31	2 in 1 CARTON	11/05/2018	05/31/2021
1		15 g 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	09/02/2015	05/31/2021

Labeler - Amorepacific Corporation (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
Amorepacific Corporation		694894112	manufacture(43419-051, 43419-052, 43419-053)