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
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NDC Code(s):
43419-511-21,
43419-511-33,
43419-512-21,
43419-513-21, view more43419-513-33, 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 November 16, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
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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
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DIRECTIONS
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
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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.
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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
- PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 104 LIGHT/MEDIUM (PINK)
- PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 106 MEDIUM (PINK)
- PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 204 LIGHT/MEDIUM (YELLOW)
- PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 208 MEDIUM (YELLOW)
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INGREDIENTS AND APPEARANCE
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-511 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.6225 g in 15 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.47 g in 15 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-511-21 2 in 1 CARTON 12/05/2012 1 15 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43419-511-33 1 in 1 CARTON 08/01/2018 08/31/2019 2 5 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2012 AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.106
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-512 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.6225 g in 15 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.47 g in 15 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-512-21 2 in 1 CARTON 12/05/2012 1 15 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2012 AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.6225 g in 15 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.47 g in 15 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-513-21 2 in 1 CARTON 12/05/2012 1 15 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:43419-513-33 1 in 1 CARTON 08/01/2018 08/31/2019 2 5 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2012 AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.208
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-514 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.6225 g in 15 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.47 g in 15 g Inactive Ingredients Ingredient Name Strength 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) CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-514-21 2 in 1 CARTON 12/05/2012 1 15 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2012 Labeler - AMOREPACIFIC CORPORATION (631035289) Establishment Name Address ID/FEI Business Operations AMOREPACIFIC CORPORATION 694894112 manufacture(43419-511, 43419-512, 43419-513, 43419-514)
