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
  • Marketing Status: OTC monograph not final

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 April 24, 2023

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

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  • 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 use on broken skin.

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

    • Stop use and ask a doctor if rash 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 21 Vanilla

    BRAOD SPECTRUM SPF50+ SUNSCREEN

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

    AIR CUSHION

    new 21

  • PRINCIPAL DISPLAY PANEL - NO. 23

    IOPE

    PERFECT COVER 21 Vanilla

    BRAOD SPECTRUM SPF50+ SUNSCREEN

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

    AIR CUSHION

    NEW 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 CARTON02/01/2020
    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 finalpart35202/01/2020
    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 not finalpart35202/01/202001/31/2024
    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 CARTON02/01/2020
    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 finalpart35202/01/2020
    Labeler - Amorepacific Corporation (631035289)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amorepacific Corporation694894112manufacture(43419-415, 43419-416, 43419-417)
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