IOPE PERFECT COVER CUSHION 23

Manufacturer
Amorepacific Corporation
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:19:46

Label at a glance#

ProductIOPE PERFECT COVER CUSHION 21
Active ingredientZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE
Label structure14 sections

Indications and 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

Dosage and administration

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 measu...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.99%
Titanium Dioxide 3.32%
Zinc Oxide 5.88%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not useon broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor ifrash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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)

INACTIVE INGREDIENT SECTION

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)

INACTIVE INGREDIENT SECTION

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)

INACTIVE INGREDIENT SECTION

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?

POSTMARKETING EXPERIENCE SECTION

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL - No. 13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

PERFECT COVER'

CUSHION

BROAD SPECTRUM SPF50+ SUNSCREEN

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

13 carton13 carton

PRINCIPAL DISPLAY PANEL - No. 21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

PERFECT COVER

Cushion

BRAOD SPECTRUM SPF50+ SUNSCREEN

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

2121

PRINCIPAL DISPLAY PANEL - NO. 23

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

PERFECT COVER

BRAOD SPECTRUM SPF50+ SUNSCREEN

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

2323

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 58 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-41543419-415-31
43419-41643419-416-31
43419-41743419-417-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 159 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b52046a-bddf-91b9-e063-6294a90a1fc79c33acf9-c159-219e-e053-2a95a90a25fc2023-11-29WarningsExact identifier
spl id: 0b52046a-bddf-91b9-e063-6294a90a1fc7
spl set id: 9c33acf9-c159-219e-e053-2a95a90a25fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.