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

  • NDC Code(s): 43419-511-21, 43419-512-21, 43419-513-21, 43419-514-21
  • Packager: AMOREPACIFIC CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • 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

    PHYLLOSTACHYS BAMBUSOIDES JUICE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, TITANIUM DIOXIDE (CI 77891), LAURYL PEG-9 POLY[1]DIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, IRON OXIDES (CI 77492), SOD[1]IUM CHLORIDE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, DISTEARDIMONI[1]UM HECTORITE, FRAGRANCE / PARFUM, STEARIC ACID, PHENOXYETHANOL, TRIETHO[1]XYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, IRON OXIDES (CI 77491), POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/ STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, ETHYL[1]HEXYLGLYCERIN, TRIMETHYLSILOXYSILICATE, DISODIUM EDTA, IRON OXIDES (CI 77499), DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, LINALOOL, WATER / AQUA / EAU, GERANIOL, ALPHA-ISOMETHYL IONONE, LIMONENE, CITRONELLOL, TOCOPHEROL, CAME[1]LLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL

  • OTHER INFORMATION

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

  • Questions?

    support@us.amorepacific.com

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

    Amore Pacific

    Color Control Cushion Compact

    Broad Spectrum SPF 50+

    Sunscreen

    Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

    104

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

    AMORE PACIFIC

    COLOR CONTROL CUSHION COMPACT

    Broad Spectrum SPF 50+
    Sunscreen

    Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

    106

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

    AMORE PACIFIC

    COLOR CONTROL CUSHION COMPACT

    Broad Spectrum SPF 50+
    Sunscreen

    Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

    204

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

    AMOREPACIFIC

    COLOR CONTROL CUSHION COMPACT

    Broad Spectrum SPF 50+

    Sunscreen

    Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

    208

  • INGREDIENTS AND APPEARANCE
    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
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    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)  
    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)  
    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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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 DrugM02012/05/2012
    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
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    ALCOHOL (UNII: 3K9958V90M)  
    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)  
    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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    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 DrugM02012/05/2012
    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
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    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)  
    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)  
    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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/05/2012
    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
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    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)  
    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)  
    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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/05/2012
    Labeler - AMOREPACIFIC CORPORATION (631035289)
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