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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
-
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
-
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
-
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?
- PRINCIPAL DISPLAY PANEL - No. 13
- PRINCIPAL DISPLAY PANEL - No. 21
- PRINCIPAL DISPLAY PANEL - NO. 23
-
INGREDIENTS AND APPEARANCE
IOPE PERFECT COVER CUSHION 21
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.764 mg in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.797 mg in 30 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.996 mg in 30 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-416-31 2 in 1 CARTON 02/01/2020 10/31/2024 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 Drug M020 02/01/2020 10/31/2024 IOPE PERFECT COVER CUSHION 13
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.797 mg in 30 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.996 mg in 30 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.764 mg in 30 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-415-31 1 in 1 CARTON 02/01/2020 01/31/2024 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 Drug M020 02/01/2020 01/31/2024 IOPE PERFECT COVER CUSHION 23
octinoxate, titanium dioxide, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-417 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.797 mg in 30 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.996 mg in 30 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.764 mg in 30 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43419-417-31 1 in 1 CARTON 02/01/2020 05/31/2024 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 Drug M020 02/01/2020 05/31/2024 Labeler - Amorepacific Corporation (631035289) Establishment Name Address ID/FEI Business Operations Amorepacific Corporation 694894112 manufacture(43419-415, 43419-416, 43419-417)