NDC 43419-415 Iope Perfect Cover Cushion 13

Octinoxate, Titanium Dioxide, And Zinc Oxide

NDC Product Code 43419-415

NDC 43419-415-31

Package Description: 1 CONTAINER in 1 CARTON > 15 g in 1 CONTAINER

NDC Product Information

Iope Perfect Cover Cushion 13 with NDC 43419-415 is a a human over the counter drug product labeled by Amorepacific Corporation. The generic name of Iope Perfect Cover Cushion 13 is octinoxate, titanium dioxide, and zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Amorepacific Corporation

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Iope Perfect Cover Cushion 13 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 1.797 mg/30g
  • TITANIUM DIOXIDE .996 mg/30g
  • ZINC OXIDE 1.764 mg/30g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • 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)
  • 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)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amorepacific Corporation
Labeler Code: 43419
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Iope Perfect Cover Cushion 13 Product Label Images

Iope Perfect Cover Cushion 13 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredients

Octinoxate 5.99%

Titanium Dioxide 3.32%

Zinc Oxide 5.88%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf 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

Otc - Do Not Use

  • Do not use on broken skin.

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • 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 exposureChildren 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?

Support@us.amorepacific.com

* Please review the disclaimer below.