AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104- octinoxate, titanium dioxide, and zinc oxide lotion 
AMOREPACIFIC  COLOR CONTROL CUSHION COMPACT NO.106- octinoxate, titanium dioxide, and zinc oxide lotion 
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204- octinoxate, titanium dioxide, and zinc oxide lotion 
AMOREPACIFIC  COLOR CONTROL CUSHION COMPACT NO.208- 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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AMOREPACIFIC COLOR CONTROL CUSHION COMPACT

Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXIDE 9.8%

PURPOSE

Sunscreen

USES

WARNINGS

  • 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

INACTIVE INGREDIENTS

PHYLLOSTACHIS BAMBUSOIDES JUICE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, PHENOXYETHANOL, POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, AQUA/WATER/EAU, SILICA, CAMELLIA JAPONICA SEED OIL, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, PARFUM/FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77492, CI 77491, CI 77499)

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 104 LIGHT/MEDIUM (PINK)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 104 LIGHT/MEDIUM (PINK)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 106 MEDIUM (PINK)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 106 MEDIUM (PINK)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 204 LIGHT/MEDIUM (YELLOW)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 204  LIGHT/MEDIUM (YELLOW)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 208 MEDIUM (YELLOW)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 208 MEDIUM (YELLOW)
AMOREPACIFIC  COLOR CONTROL CUSHION COMPACT NO.104
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-511
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
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
ALCOHOL (UNII: 3K9958V90M)  
ARBUTIN (UNII: C5INA23HXF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-511-212 in 1 CARTON12/05/2012
115 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:43419-511-331 in 1 CARTON08/01/201808/31/2019
25 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 finalpart35212/05/2012
AMOREPACIFIC   COLOR CONTROL CUSHION COMPACT NO.106
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-512
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
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
ALCOHOL (UNII: 3K9958V90M)  
ARBUTIN (UNII: C5INA23HXF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-512-212 in 1 CARTON12/05/2012
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 finalpart35212/05/2012
AMOREPACIFIC  COLOR CONTROL CUSHION COMPACT NO.204
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-513
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
ALCOHOL (UNII: 3K9958V90M)  
ARBUTIN (UNII: C5INA23HXF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-513-212 in 1 CARTON12/05/2012
115 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:43419-513-331 in 1 CARTON08/01/201808/31/2019
25 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 finalpart35212/05/2012
AMOREPACIFIC   COLOR CONTROL CUSHION COMPACT NO.208
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-514
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
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
ALCOHOL (UNII: 3K9958V90M)  
ARBUTIN (UNII: C5INA23HXF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-514-212 in 1 CARTON12/05/2012
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 finalpart35212/05/2012
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION 694894112manufacture(43419-511, 43419-512, 43419-513, 43419-514)

Revised: 9/2019
Document Id: 91d27da2-349e-8a39-e053-2a95a90a07e6
Set id: 60964d9f-d96c-4397-b273-6b63d1886722
Version: 7
Effective Time: 20190905
 
AMOREPACIFIC CORPORATION