Sulwhasoo EVENFAIR SMOOTHING FOUNDATION

Sulwhasoo EVENFAIR SMOOTHING FOUNDATION by

Drug Labeling and Warnings

Sulwhasoo EVENFAIR SMOOTHING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SULWHASOO EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 2 MEDIUM BEIGE- octinoxate liquid 
SULWHASOO EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 3 MEDIUM OCHER- octinoxate liquid 
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 FOUNDATION

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, TITANIUM DIOXIDE (CI 77891), CYCLOHEXASILOXANE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIMETHICONE, PEG-10 DIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, NEOPENTYL GLYCOL DIHEPTANOATE, PEG-30 DIPOLYHYDROXYSTEARATE, DISTEARDIMONIUM HECTORITE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, POLYMETHYLSILSESQUIOXANE, IRON OXIDES (CI 77492), POLYMETHYL METHACRYLATE, OCTYLDODECYL MYRISTATE, HYDROGENATED POLYDECENE, POLYETHYLENE, SODIUM POLYACRYLATE STARCH, ALUMINUM HYDROXIDE, FRAGRANCE, CAPRYLYL GLYCOL, MICA (CI 77019), IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE, PEG/PPG-20/15 DIMETHICONE, TRIETHYL CITRATE, PHENYL METHICONE, IRON OXIDES (CI 77499), DISODIUM EDTA, ADENOSINE, CHRYSANTHEMUM MORIFOLIUM FLOWER EXTRACT, CITRUS UNSHIU PEEL EXTRACT, 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, ALUMINA, SILICA, HONEY, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, ANGELICA TENUISSIMA ROOT EXTRACT, 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 Bottle Carton - MEDIUM BEIGE

Sulwhasoo

EVENFAIR

SMOOTHING
FOUNDATION

NO. 2
MEDIUM BEIGE

30 ml / 1.01 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - MEDIUM BEIGE

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - MEDIUM OCHER

Sulwhasoo

EVENFAIR

SMOOTHING
FOUNDATION

NO. 3
MEDIUM OCHER

30 ml / 1.01 fl. oz.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - MEDIUM OCHER
SULWHASOO EVENFAIR SMOOTHING FOUNDATION  SPF25 NO. 2 MEDIUM BEIGE
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-023
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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-023-021 in 1 CARTON11/23/201208/31/2019
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/23/201208/31/2019
SULWHASOO EVENFAIR SMOOTHING FOUNDATION  SPF25 NO. 3 MEDIUM OCHER
octinoxate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-024
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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-024-021 in 1 CARTON11/23/201208/31/2019
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/23/201208/31/2019
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112manufacture(43419-023, 43419-024)

Revised: 11/2019
Document Id: 96c9023e-6a1d-3179-e053-2a95a90afad2
Set id: 604b6fc4-21cc-4e8e-8428-570872b58be1
Version: 7
Effective Time: 20191107
 
AMOREPACIFIC CORPORATION