Label: AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102- zinc oxide, octinoxate, and titanium dioxide lotion
- NDC Code(s): 43419-528-31
- Packager: AMOREPACIFIC CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- 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
- Questions?
- PRINCIPAL DISPLAY PANEL - 30 g (15 g x 2) Container Carton
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INGREDIENTS AND APPEARANCE
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102
zinc oxide, octinoxate, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-528 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.94 g in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.1 g in 30 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.245 g in 30 g Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) ALCOHOL (UNII: 3K9958V90M) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) STEARIC ACID (UNII: 4ELV7Z65AP) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOSTEARIC ACID (UNII: X33R8U0062) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) FERRIC OXIDE RED (UNII: 1K09F3G675) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-528-31 2 in 1 CARTON 06/05/2017 1 15 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/26/2016 Labeler - AMOREPACIFIC CORPORATION (631035289) Establishment Name Address ID/FEI Business Operations Amorepacific Corporation 694894112 manufacture(43419-528)