Label: 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

  • NDC Code(s): 43419-511-21, 43419-511-33, 43419-512-21, 43419-513-21, view more
    43419-513-33, 43419-514-21
  • Packager: AMOREPACIFIC CORPORATION
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 5, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

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

  • 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

    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)
  • INGREDIENTS AND APPEARANCE
    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)