SULWHASOO PERFECTING CUSHION NO.11 PALE PINK- octinoxate, titanium dioxide, and zinc oxide lotion 
SULWHASOO PERFECTING CUSHION NO.13 LIGHT PINK- octinoxate, titanium dioxide, and zinc oxide lotion 
SULWHASOO PERFECTING CUSHION NO.21 MEDIUM PINK- octinoxate, titanium dioxide, and zinc oxide lotion 
SULWHASOO PERFECTING CUSHION NO.23 MEDIUM BEIGE- octinoxate, titanium dioxide, and zinc oxide lotion 
SULWHASOO PERFECTING CUSHION NO.25 DEEP BEIGE- octinoxate, titanium dioxide, and zinc oxide lotion 
SULWHASOO PERFECTING CUSHION NO.33 DARK BEIGE- octinoxate, titanium dioxide, and zinc oxide 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.

----------

Sulwhasoo PERFECTING CUSHION

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.

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

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 11 PALE PINK

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 11
PALE PINK

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 11 PALE PINK

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 13 LIGHT PINK

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 13
LIGHT PINK

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 13 LIGHT PINK

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

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 21
MEDIUM PINK

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

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

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

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 23
MEDIUM BEIGE

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

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

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

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 25
DEEP BEIGE

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

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 33 DARK BEIGE

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN

NO. 33
DARK BEIGE

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - NO. 33 DARK BEIGE
SULWHASOO PERFECTING CUSHION NO.11 PALE PINK 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALCOHOL (UNII: 3K9958V90M)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-061-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/201605/31/2021
SULWHASOO PERFECTING CUSHION NO.13 LIGHT PINK 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALCOHOL (UNII: 3K9958V90M)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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)  
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-062-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
2NDC:43419-062-362 in 1 CARTON07/23/201808/31/2021
22 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 finalpart35205/26/201608/31/2021
SULWHASOO PERFECTING CUSHION NO.21 MEDIUM PINK 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-063-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
2NDC:43419-063-362 in 1 CARTON08/01/201807/22/2021
22 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 finalpart35205/26/201607/22/2021
SULWHASOO PERFECTING CUSHION NO.23 MEDIUM BEIGE 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-064-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/201605/31/2021
SULWHASOO PERFECTING CUSHION NO.25 DEEP BEIGE 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-065-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/201605/31/2021
SULWHASOO PERFECTING CUSHION NO.33 DARK BEIGE 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-066-312 in 1 CARTON05/26/201605/31/2021
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/201605/31/2021
Labeler - Amorepacific Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Amorepacific Corporation694894112manufacture(43419-061, 43419-062, 43419-063, 43419-064, 43419-065, 43419-066)

Revised: 12/2019
 
Amorepacific Corporation