Label: IOPE PERFECT COVER CUSHION 21- octinoxate, titanium dioxide, and zinc oxide lotion
IOPE PERFECT COVER CUSHION 13- octinoxate, titanium dioxide, and zinc oxide lotion
IOPE PERFECT COVER CUSHION 23- octinoxate, titanium dioxide, and zinc oxide lotion

  • NDC Code(s): 43419-415-31, 43419-416-31, 43419-417-31
  • Packager: Amorepacific Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Octinoxate 5.99%
    Titanium Dioxide 3.32%
    Zinc Oxide 5.88%

  • 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 useon broken skin.

    • When using this productavoid contact with eyes. If contact occurs, rinse thoroughly with water.

    • Stop use and ask a doctor ifrash occurs.

    • Keep out of reach of children.If swallowed, call a poison control centre or get medical help right away.
  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age : Ask a doctor.
    • 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.
  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun.
    • Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • INACTIVE INGREDIENTS(NO. 13)

    WATER / AQUA / EAU, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891),
    PROPANEDIOL, CYCLOHEXASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE,
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE,
    CETYL ETHYLHEXANOATE, NIACINAMIDE, DISTEARDIMONIUM HECTORITE,
    ISODODECANE, GLYCERIN, SODIUM CHLORIDE, BORON NITRIDE, PEG-10
    DIMETHICONE, TRIMETHYLSILOXYSILICATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE
    COPOLYMER, IRON OXIDES (CI 77492), SILICA, ALUMINUM HYDROXIDE,
    OZOKERITE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE
    COPOLYMER, EUPHORBIA CERIFERA (CANDELILLA) WAX / CANDELILLA CERA HYDROCARBONS
    / CIRE DE CANDELILLA, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID,
    FRAGRANCE / PARFUM, PHYTOSTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE,
    IRON OXIDES (CI 77491), CAPRYLYL GLYCOL, ACRYLATES/ETHYLHEXYL
    ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, GLYCERYL CAPRYLATE,
    ETHYLHEXYLGLYCERIN, BUTYLENE GLYCOL, IRON OXIDES (CI 77499), DISODIUM
    EDTA, ADENOSINE, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, BHT, PROPYLENE
    GLYCOL, TOCOPHEROL, ACETYL GLUCOSAMINE, POLYGLYCERYL-10 STEARATE,
    LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, CERAMIDE NP, HYDROXYPROPYL
    BISPALMITAMIDE MEA, HYDROGENATED LECITHIN, PEG-5 RAPESEED
    STEROL, PALMITIC ACID, COPPER TRIPEPTIDE-1, PHENOXYETHANOL, POLYACRYLATE-
    13, POTASSIUM CETYL PHOSPHATE, SODIUM HYALURONATE, POLYISOBUTENE,
    PHYTOSPHINGOSINE, POLYSORBATE 20, SORBITAN ISOSTEARATE

  • INACTIVE INGREDIENTS(NO. 21)

    WATER / AQUA / EAU , CYCLOPENTASILOXANE , BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE , CYCLOHEXASILOXANE, TITANIUM DIOXIDE (CI 77891) , PEG-10 DIMETHICONE , PROPANEDIOL , LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE , NIACINAMIDE , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , IRON OXIDES (CI 77492) , POLYHYDROXYSTEARIC ACID , SODIUM CHLORIDE , METHYL METHACRYLATE CROSSPOLYMER , ALUMINUM HYDROXIDE , FRAGRANCE / PARFUM , STEARIC ACID , DIMETHICONE , TRIETHOXYCAPRYLYLSILANE , DISTEARDIMONIUM HECTORITE , ISOPROPYL PALMITATE , ISOSTEARIC ACID , LECITHIN , ETHYLHEXYL PALMITATE , CAPRYLYL GLYCOL , IRON OXIDES (CI 77491) , POLYGLYCERYL-3 POLYRICINOLEATE , DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER , ETHYLHEXYLGLYCERIN , ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , IRON OXIDES (CI 77499) , TRIMETHYLSILOXYSILICATE , DISODIUM EDTA , ADENOSINE , TREHALOSE , BUTYLENE GLYCOL , SYNTHETIC FLUORPHLOGOPITE , POLYMETHYL METHACRYLATE , LACTIC ACID , PCA , GLUCOSE , TIN OXIDE , GLYCINE , SILICA , SODIUM GLYCEROPHOSPHATE , UREA , SERINE , GLUTAMIC ACID , POTASSIUM MAGNESIUM ASPARTATE , ASPARTIC ACID , LEUCINE , ALANINE , LYSINE , ARGININE , MAGNESIUM GLUCONATE , CALCIUM GLUCONATE , TYROSINE , PHENYLALANINE , THREONINE , VALINE , PROLINE , ISOLEUCINE , CITRIC ACID , HISTIDINE , ACETYL GLUCOSAMINE , CREATINE , URIC ACID , CYSTEINE , METHIONINE , LIPASE , CHITOSAN.

  • INACTIVE INGREDIENTS(NO. 23)

    AQUA / EAU , CYCLOPENTASILOXANE , BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE , CYCLOHEXASILOXANE
    , TITANIUM DIOXIDE (CI 77891) , PEG-10 DIMETHICONE , PROPANEDIOL , LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE , NIACINAMIDE , IRON OXIDES (CI 77492) , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE , ALUMINUM HYDROXIDE , FRAGRANCE / PARFUM , STEARIC ACID , DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER , TRIETHOXYCAPRYLYLSILANE , DISTEARDIMONIUM HECTORITE, ISOSTEARIC ACID , ISOPROPYL PALMITATE , LECITHIN , ETHYLHEXYL PALMITATE , CAPRYLYL GLYCOL , IRON OXIDES (CI 77491) , POLYGLYCERYL-3 POLYRICINOLEATE , DIMETHICONE/VINYL DIMETHICONE
    CROSSPOLYMER , IRON OXIDES (CI 77499) , ETHYLHEXYLGLYCERIN , ACRYLATES/STEARYL ACRYLATE/DIMETHICONE
    METHACRYLATE COPOLYMER , TRIMETHYLSILOXYSILICATE , DISODIUM EDTA , ADENOSINE , TREHALOSE ,
    BUTYLENE GLYCOL , SYNTHETIC FLUORPHLOGOPITE , POLYMETHYL METHACRYLATE , LACTIC ACID , PCA,
    GLUCOSE , TIN OXIDE , GLYCINE , SILICA , SODIUM GLYCEROPHOSPHATE , UREA , SERINE , GLUTAMIC ACID,
    POTASSIUM MAGNESIUM ASPARTATE , ASPARTIC ACID , LEUCINE , ALANINE , LYSINE , ARGININE , MAGNESIUM
    GLUCONATE , CALCIUM GLUCONATE , TYROSINE , PHENYLALANINE , THREONINE , VALINE , PROLINE ,
    ISOLEUCINE , CITRIC ACID , HISTIDINE , ACETYL GLUCOSAMINE , CREATINE , URIC ACID , CYSTEINE ,
    METHIONINE , LIPASE , CHITOSAN.

  • Questions?

    support@us.amorepacific.com

  • PRINCIPAL DISPLAY PANEL - No. 13

    IOPE

    PERFECT COVER'

    CUSHION

    BROAD SPECTRUM SPF50+ SUNSCREEN

    30g(15gX2) / Net Wt. 1.05 OZ.

    13 carton

  • PRINCIPAL DISPLAY PANEL - No. 21

    IOPE

    PERFECT COVER

    Cushion

    BRAOD SPECTRUM SPF50+ SUNSCREEN

    Net Wt. 1.05 OZ. / 30 g (15 g x 2)

    21

  • PRINCIPAL DISPLAY PANEL - NO. 23

    IOPE

    PERFECT COVER

    BRAOD SPECTRUM SPF50+ SUNSCREEN

    Net Wt. 1.05 OZ. / 30 g (15 g x 2)

    23

  • INGREDIENTS AND APPEARANCE
    IOPE PERFECT COVER CUSHION 21 
    octinoxate, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.764 mg  in 30 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.797 mg  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.996 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LEVANT COTTON SEED (UNII: 550E4N439V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-5 RAPESEED STEROL (UNII: NS80WJS6KK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    ISODODECANE (UNII: A8289P68Y2)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ADENOSINE (UNII: K72T3FS567)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-416-312 in 1 CARTON02/01/202010/31/2024
    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 DrugM02002/01/202010/31/2024
    IOPE PERFECT COVER CUSHION 13 
    octinoxate, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.797 mg  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.996 mg  in 30 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.764 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ISODODECANE (UNII: A8289P68Y2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEVANT COTTON SEED (UNII: 550E4N439V)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ADENOSINE (UNII: K72T3FS567)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
    PEG-5 RAPESEED STEROL (UNII: NS80WJS6KK)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-415-311 in 1 CARTON02/01/202001/31/2024
    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 DrugM02002/01/202001/31/2024
    IOPE PERFECT COVER CUSHION 23 
    octinoxate, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.797 mg  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.996 mg  in 30 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.764 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ISODODECANE (UNII: A8289P68Y2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEVANT COTTON SEED (UNII: 550E4N439V)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ADENOSINE (UNII: K72T3FS567)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
    PEG-5 RAPESEED STEROL (UNII: NS80WJS6KK)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-417-311 in 1 CARTON02/01/202005/31/2024
    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 DrugM02002/01/202005/31/2024
    Labeler - Amorepacific Corporation (631035289)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amorepacific Corporation694894112manufacture(43419-415, 43419-416, 43419-417)