SULWHASOO EVENFAIR CREAM COMPACT

Drug Labeling and Warnings

Drug Details [pdf]

SULWHASOO EVENFAIR COMPACT NO.21- octinoxate and titanium dioxide cream 
SULWHASOO EVENFAIR COMPACT NO.24- octinoxate and titanium dioxide cream 
SULWHASOO EVENFAIR COMPACT NO.26- octinoxate and titanium dioxide cream 
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 CREAM COMPACT

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 2%
TITANIUM DIOXIDE 20%

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

C12-15 ALKYL ETHYLHEXANOATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DICAPRYLYL CARBONATE, METHYL METHACRYLATE CROSSPOLYMER, DEXTRIN PALMITATE, MICA (CI 77019), ALUMINA, BORON NITRIDE, IRON OXIDES (CI 77492), POLYMETHYLSILSESQUIOXANE, VP/HEXADECENE COPOLYMER, SORBITAN SESQUIOLEATE, LAURYL PEG/PPG-18/18 METHICONE, POLYHYDROXYSTEARIC ACID, DEXTRIN PALMITATE/ETHYLHEXANOATE, IRON OXIDES (CI 77491), FRAGRANCE, ETHYLHEXYLGLYCERIN, METHICONE, GLYCERYL CAPRYLATE, CAMELLIA SINENSIS LEAF EXTRACT, IRON OXIDES (CI 77499), SILICA, BUTYLENE GLYCOL, POLYGONATUM OFFICINALE RHIZOME/ROOT EXTRACT, REHMANNIA GLUTINOSA ROOT EXTRACT, LILIUM TIGRINUM FLOWER/LEAF/STEM EXTRACT, PAEONIA ALBIFLORA ROOT EXTRACT, NELUMBO NUCIFERA SEED EXTRACT, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, HONEY, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, PRUNUS PERSICA (PEACH) KERNEL EXTRACT, HONEY EXTRACT

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 11 g Jar Carton - NO. 21 MEDIUM PINK

Sulwhasoo

EVENFAIR

PERFECTING CREAM COMPACT

BROAD SPECTRUM
SPF25
SUNSCREEN

NO. 21
MEDIUM PINK

11 g / Net wt. 0.38 oz.

Principal Display Panel - 11 g Jar Carton - NO. 21 MEDIUM PINK

PRINCIPAL DISPLAY PANEL- 11 g Jar Carton - NO. 24 MEDIUM OCHER

Sulwhasoo

EVENFAIR

PERFECTING CREAM COMPACT

BROAD SPECTRUM
SPF25
SUNSCREEN

NO. 24
MEDIUM OCHER

11 g / Net wt. 0.38 oz.

Principal Display Panel - 11 g Jar Carton - NO. 24 MEDIUM OCHER

PRINCIPAL DISPLAY PANEL - 11 g Jar Carton - NO. 26 DARK BEIGE

Sulwhasoo

EVENFAIR

PERFECTING CREAM COMPACT

BROAD SPECTRUM
SPF25
SUNSCREEN

NO. 26
DARK BEIGE

11 g / Net wt. 0.38 oz.

Principal Display Panel - 11 g Jar Carton - NO. 26 DARK BEIGE
SULWHASOO EVENFAIR COMPACT NO.21 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.22 g  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
MICA (UNII: V8A1AW0880)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
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)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
HONEY (UNII: Y9H1V576FH)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-034-161 in 1 CARTON11/05/201808/31/2019
111 g in 1 JAR; 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 COMPACT NO.24 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.22 g  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
MICA (UNII: V8A1AW0880)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
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)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
HONEY (UNII: Y9H1V576FH)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-035-161 in 1 CARTON11/05/201808/31/2019
111 g in 1 JAR; 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 COMPACT NO.26 
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.22 g  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
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)  
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
HONEY (UNII: Y9H1V576FH)  
PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
PRUNUS PERSICA SEED (UNII: V9C81470RR)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
MICA (UNII: V8A1AW0880)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-036-161 in 1 CARTON11/05/201808/31/2019
111 g in 1 JAR; 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(43419-034, 43419-035, 43419-036)

Revised: 9/2019
Document Id: 91d5008b-a2ca-d593-e053-2a95a90a549a
Set id: becd580d-a32b-4477-9d75-17de7ad99976
Version: 3
Effective Time: 20190905
 
Amorepacific Corporation