Sulwhasoo EVENFAIR SMOOTHING MAKEUP BASE

Drug Labeling and Warnings

Drug Details [pdf]

SULWHASOO EVENFAIR SMOOTHING MAKEUP BASE NO. 1- octinoxate lotion 
SULWHASOO EVENFAIR SMOOTHING MAKEUP BASE NO. 2- octinoxate 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 SMOOTHING MAKEUP BASE

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 6.5%

PURPOSE

Sunscreen

USES

  • Helps prevent sunburn

WARNINGS

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • 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
  • Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, PHENYL TRIMETHICONE, CYCLOHEXASILOXANE, CETYL ETHYLHEXANOATE, TITANIUM DIOXIDE (CI 77891), PEG-10 DIMETHICONE, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, BEESWAX, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED CASTOR OIL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, CAPRYLYL GLYCOL, MICA (CI 77019), FRAGRANCE, ALCOHOL, IRON OXIDES (CI 77492), GLYCERYL CAPRYLATE, POLYMETHYLSILSESQUIOXANE, POLYSORBATE 80, ALUMINUM HYDROXIDE, HYDROGENATED LECITHIN, TRIETHOXYCAPRYLYLSILANE, DISODIUM EDTA, ADENOSINE, IRON OXIDES (CI 77491), POLYMETHYL METHACRYLATE, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CITRUS UNSHIU PEEL EXTRACT, SODIUM HYALURONATE, LACTIC ACID, SODIUM LACTATE, POLYGONATUM OFFICINALE RHIZOME /ROOT EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, NELUMBO NUCIFERA SEED EXTRACT, COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT, ADENOPHORA STRICTA ROOT EXTRACT, SILICA, IRON OXIDES (CI 77499), HONEY, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, ANGELICA TENUISSIMA ROOT EXTRACT, ALUMINA, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, PRUNUS PERSICA (PEACH) KERNEL EXTRACT, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, HONEY EXTRACT

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton - No. 1

Sulwhasoo

EVENFAIR

SMOOTHING
MAKEUP BASE

NO. 1
LIGHT BEIGE

30 ml / 1.01 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton - No. 1

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton - No. 2

Sulwhasoo

EVENFAIR

SMOOTHING
MAKEUP BASE

NO. 2
LIGHT GREEN

30 ml / 1.01 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton - No. 2
SULWHASOO EVENFAIR SMOOTHING MAKEUP BASE NO. 1 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.95 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CASTOR OIL (UNII: D5340Y2I9G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
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)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-027-231 in 1 CARTON02/15/201308/31/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/15/201308/31/2019
SULWHASOO EVENFAIR SMOOTHING MAKEUP BASE NO. 2 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.95 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CASTOR OIL (UNII: D5340Y2I9G)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
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)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-028-231 in 1 CARTON02/15/201308/31/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/15/201308/31/2019
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-027, 43419-028)

Revised: 9/2019
Document Id: 91d42b06-758b-3aff-e053-2995a90ab906
Set id: 50902655-77ad-4c99-97d4-ec9313b060a3
Version: 6
Effective Time: 20190905
 
AMOREPACIFIC CORPORATION