SULWHASOO EVENFAIR PERFECTING CUSHION

Drug Labeling and Warnings

Drug Details [pdf]

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

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SULWHASOO EVENFAIR PERFECTING CUSHION

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXID 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

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

OTHER INFORMATION

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

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

Sulwhasoo

EVENFAIR

PERFECTING CUSHION

BROAD SPECTRUM
SPF50+
SUNSCREEN

NO. 21
MEDIUM PINK

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

Principal Display Panel - 30 g Jar Carton - NO. 21 MEDIUM PINK

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

Sulwhasoo

EVENFAIR

PERFECTING CUSHION

BROAD SPECTRUM
SPF50+
SUNSCREEN

NO. 23
MEDIUM BEIGE

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

Principal Display Panel - 30 g Jar Carton - NO. 23 MEDIUM BEIGE

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

Sulwhasoo

EVENFAIR

PERFECTING CUSHION

BROAD SPECTRUM
SPF50+
SUNSCREEN

NO. 25
DEEP BEIGE

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

Principal Display Panel - 30 g Jar Carton - NO. 25 DEEP BEIGE
SULWHASOO EVENFAIR PERFECTING CUSHION NO.21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-031-212 in 1 CARTON02/05/201408/31/2019
115 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 finalpart35202/05/201408/31/2019
SULWHASOO EVENFAIR PERFECTING CUSHION NO.23 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-032-212 in 1 CARTON02/05/201408/31/2019
115 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 finalpart35202/05/201408/31/2019
SULWHASOO EVENFAIR PERFECTING CUSHION NO.25 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-033-212 in 1 CARTON02/05/201408/31/2019
115 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 finalpart35202/05/201408/31/2019
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-031, 43419-032, 43419-033)

Revised: 9/2019