Drug Labeling and Warnings

Drug Details

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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 
Amorepacific Corporation

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 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, TITANIUM DIOXIDE (CI 77891),
PROPANEDIOL, CYCLOHEXASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE,
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE,
CETYL ETHYLHEXANOATE, NIACINAMIDE, DISTEARDIMONIUM HECTORITE,
ISODODECANE, IRON OXIDES (CI 77492), GLYCERIN, SODIUM CHLORIDE,
BORON NITRIDE, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, ACRYLATES/
POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, 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, IRON OXIDES (CI 77499), BUTYLENE GLYCOL, 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. 23)

WATER / AQUA / EAU, CYCLOPENTASILOXANE, TITANIUM DIOXIDE (CI 77891),
PROPANEDIOL, CYCLOHEXASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE,
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CETYL ETHYLHEXANOATE,
NIACINAMIDE, IRON OXIDES (CI 77492), DISTEARDIMONIUM HECTORITE,
POLYMETHYL METHACRYLATE, ISODODECANE, GLYCERIN, SODIUM CHLORIDE,
BORON NITRIDE, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, ACRYLATES/
POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, SILICA, ALUMINUM HYDROXIDE,
OZOKERITE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER,
EUPHORBIA CERIFERA (CANDELILLA) WAX / CANDELILLA CERA HYDROCARBONS
/ CIRE DE CANDELILLA, IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE,
STEARIC ACID, FRAGRANCE / PARFUM, PHYTOSTERYL/BEHENYL/OCTYLDODECYL
LAUROYL GLUTAMATE, CAPRYLYL GLYCOL, IRON OXIDES (CI 77499), ACRYLATES/
ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, GLYCERYL
CAPRYLATE, ETHYLHEXYLGLYCERIN, BUTYLENE GLYCOL, 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

Questions?

[email protected]

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

30g (15g X2) / Net Wt. 1.05 OZ.

21 carton

PRINCIPAL DISPLAY PANEL - NO. 23

IOPE

PERFECT COVER

CUSHION

BROAD SPECTRUM SPF50+ SUNSCREEN

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

23 carton

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
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
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LEVANT COTTON SEED (UNII: 550E4N439V)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
PEG-5 RAPESEED STEROL (UNII: NS80WJS6KK)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CERAMIDE NP (UNII: 4370DF050B)  
PALMITIC ACID (UNII: 2V16EO95H1)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
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)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
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)  
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)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
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)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-415-311 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
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)

Revised: 2/2020
 
Amorepacific Corporation


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