Sulwhasoo EVENFAIR SMOOTHING POWDER FOUNDATION

Drug Labeling and Warnings

Drug Details [pdf]

SULWHASOO EVENFAIR SMOOTHING FOUNDATION SPF25 NO.2 MEDIUM BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
SULWHASOO EVENFAIR SMOOTHING FOUNDATION SPF25 NO.3 MEDIUM OCHER- octinoxate, titanium dioxide, and zinc oxide powder 
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 POWDER FOUNDATION

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 3.2%

TITANIUM DIOXIDE 4.268%

ZINC OXIDE 1.96%

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

TALC, MICA (CI 77019), TITANIUM DIOXIDE (CI 77891), POLYMETHYLSILSESQUIOXANE, NYLON 6/12, SILICA, PHENYL TRIMETHICONE, HEXYL LAURATE, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, IRON OXIDES (CI 77492), BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIISOSTEARYL MALATE, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, IRON OXIDES (CI 77491), ETHYLHEXYLGLYCERIN, METHICONE, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, GLYCERYL CAPRYLATE, IRON OXIDES (CI 77499), ALUMINA, BUTYLENE GLYCOL, ULTRAMARINES (CI 77007), 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, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, PRUNUS PERSICA (PEACH) KERNEL EXTRACT, HONEY, PAEONIA SUFFRUTICOSA ROOT EXTRACT, LYCIUM CHINENSE ROOT EXTRACT, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, ANGELICA TENUISSIMA ROOT EXTRACT, HONEY EXTRACT

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - NO. 2 MEDIUM BEIGE

Sulwhasoo

EVENFAIR
SMOOTHING POWDER FOUNDATION

SPF25
SUNSCREEN

NO. 2
MEDIUM BEIGE

Net wt. 0.35 oz. / 10 g

Principal Display Panel - 10 g Container Carton - NO. 2 MEDIUM BEIGE

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - NO. 3 MEDIUM OCHER

Sulwhasoo

EVENFAIR
SMOOTHING POWDER FOUNDATION

SPF25
SUNSCREEN

NO. 3
medium ocher

Net wt. 0.35 oz. / 10 g

Principal Display Panel - 10 g Container Carton - NO. 3 MEDIUM OCHER
SULWHASOO EVENFAIR SMOOTHING FOUNDATION  SPF25 NO.2 MEDIUM BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.32 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.4268 g  in 10 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.196 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-025-201 in 1 CARTON11/23/201208/31/2019
110 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 finalpart35211/23/201208/31/2019
SULWHASOO EVENFAIR SMOOTHING FOUNDATION  SPF25 NO.3 MEDIUM OCHER
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.32 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.4268 g  in 10 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.196 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CHRYSANTHEMUM X MORIFOLIUM FLOWER (UNII: 2GR3C1A0WV)  
TANGERINE PEEL (UNII: JU3D414057)  
LILIUM LANCIFOLIUM FLOWERING TOP (UNII: 6268MFA917)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
NELUMBO NUCIFERA SEED (UNII: YCT65RT6AE)  
POLYGONATUM ODORATUM ROOT (UNII: KPF03O64AZ)  
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
ADENOPHORA STRICTA ROOT (UNII: C768H06N7E)  
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
HONEY (UNII: Y9H1V576FH)  
LYCIUM CHINENSE ROOT BARK (UNII: 2Q9D9P290N)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-026-201 in 1 CARTON11/23/201208/31/2019
110 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 finalpart35211/23/201208/31/2019
Labeler - Amorepacific Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Amorepacific Corporation694894112manufacture(43419-025, 43419-026)

Revised: 9/2019