FDA.reportPublic FDA data

IOPE AIR CUSHION Cover 31 Warm Beige

Manufacturer
AMOREPACIFIC CORPORATION
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:23:45

Label at a glance#

ProductIOPE AIR CUSHION Cover 13 Ivory
Active ingredientZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE
Label structure11 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure. 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, especial...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS W/WPurpose
OCTINOXATE 7%Sunscreen
TITANIUM DIOXIDE 4.15%Sunscreen
ZINC OXIDE 9.8%Sunscreen

USE

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

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes.
  • rinse with water to remove.

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • 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.
  • Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

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 , METHYL METHACRYLATE CROSSPOLYMER , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , POLYHYDROXYSTEARIC ACID , SODIUM CHLORIDE , ALUMINUM HYDROXIDE , IRON OXIDES (CI 77492) , 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 , RON 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.

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 13 Ivory

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

AIR CUSHION ® COVER 13 IVORY
BROAD SPECTRUM SPF 50+ SUNSCREEN
Net wt. 1.05 OZ. / 30 g (15 g x 2)

AIR CUSHION ®

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 13 Ivory
PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 13 Ivory

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 21 Vanilla

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

AIR CUSHION ® COVER 21 VANILLA

BROAD SPECTRUM SPF 50+ SUNSCREEN

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

AIR CUSHION ®

2121

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 23 Beige

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

AIR CUSHION ® COVER 23 BEIGE

BROAD SPECTRUM SPF 50+ SUNSCREEN

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

AIR CUSHION ®

2323

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 31 Warm Beige

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

IOPE AIR CUSHION ® COVER 31 WARM BEIGE

BROAD SPECTRUM SPF 50+ SUNSCREEN

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

AIR CUSHION ®

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 31 Warm BeigePRINCIPAL DISPLAY PANEL - 15 g Container Carton - 31 Warm Beige

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43419-403-31IOPE AIR CUSHION Cover 13 Ivory15 g in 1 CONTAINERLOTION159
43419-403-31IOPE AIR CUSHION Cover 13 Ivory2 in 1 CARTONLOTION29
43419-404-31IOPE AIR CUSHION Cover 21 Vanilla2 in 1 CARTONLOTION29
43419-404-31IOPE AIR CUSHION Cover 21 Vanilla15 g in 1 CONTAINERLOTION159
43419-405-31IOPE AIR CUSHION Cover 23 Beige15 g in 1 CONTAINERLOTION159
43419-405-31IOPE AIR CUSHION Cover 23 Beige2 in 1 CARTONLOTION29
43419-414-31IOPE AIR CUSHION Cover 31 Warm Beige2 in 1 CARTONLOTION29
43419-414-31IOPE AIR CUSHION Cover 31 Warm Beige15 g in 1 CONTAINERLOTION159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43419-403IOPE AIR CUSHION COVER 13 IVORY (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 21 VANILLA (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 23 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 31 WARM BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION [AMOREPACIFIC CORPORATION]9Legacy NDC, 2 package rows20241010_29d6cc8d-1469-479d-a15a-e78d4e22d4a2.zip
43419-404IOPE AIR CUSHION COVER 13 IVORY (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 21 VANILLA (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 23 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 31 WARM BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION [AMOREPACIFIC CORPORATION]9Current NDC, Legacy NDC, 2 package rows20241010_29d6cc8d-1469-479d-a15a-e78d4e22d4a2.zip
43419-405IOPE AIR CUSHION COVER 13 IVORY (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 21 VANILLA (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 23 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 31 WARM BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION [AMOREPACIFIC CORPORATION]9Current NDC, Legacy NDC, 2 package rows20241010_29d6cc8d-1469-479d-a15a-e78d4e22d4a2.zip
43419-414IOPE AIR CUSHION COVER 13 IVORY (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 21 VANILLA (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 23 BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION IOPE AIR CUSHION COVER 31 WARM BEIGE (ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE) LOTION [AMOREPACIFIC CORPORATION]9Legacy NDC, 2 package rows20241010_29d6cc8d-1469-479d-a15a-e78d4e22d4a2.zip

Products#

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

DailyMed product names page 1 of 2 · 69 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-40343419-403-31
43419-40443419-404-31
43419-40543419-405-31
43419-41443419-414-31

Ingredients#

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

DailyMed ingredient rows page 1 of 7 · 246 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ADENOSINEK72T3FS567IACT
TREHALOSEB8WCK70T7IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
PIDOLIC ACIDSZB83O1W42IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
STANNIC OXIDEKM7N50LOS6IACT
GLYCINETE7660XO1CIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
UREA8W8T17847WIACT
SODIUM GLYCEROPHOSPHATERCS9EQ01V4IACT
SERINE452VLY9402IACT
GLUTAMIC ACID3KX376GY7LIACT
POTASSIUM MAGNESIUM ASPARTATE55TUI7Q42IIACT
ASPARTIC ACID30KYC7MIAIIACT
LEUCINEGMW67QNF9CIACT
ALANINEOF5P57N2ZXIACT
LYSINEK3Z4F929H6IACT
ARGININE94ZLA3W45FIACT
CALCIUM GLUCONATESQE6VB453KIACT
MAGNESIUM GLUCONATET42NAD2KHCIACT
TYROSINE42HK56048UIACT
PHENYLALANINE47E5O17Y3RIACT
PROLINE9DLQ4CIU6VIACT
THREONINE2ZD004190SIACT
VALINEHG18B9YRS7IACT
ISOLEUCINE04Y7590D77IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HISTIDINE4QD397987EIACT
N-ACETYLGLUCOSAMINEV956696549IACT
CREATINEMU72812GK0IACT
URIC ACID268B43MJ25IACT
CYSTEINEK848JZ4886IACT
METHIONINEAE28F7PNPLIACT
ZINC OXIDESOI2LOH54ZACTIB

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
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
ndc (package): 43419-414-31
ndc (package): 43419-403-31
ndc (package): 43419-404-31
ndc (package): 43419-405-31
ndc (product): 43419-403
ndc (product): 43419-404
ndc (product): 43419-405
ndc (product): 43419-414
ndc11 (package): 43419041431
ndc11 (package): 43419040331
ndc11 (package): 43419040531
ndc11 (package): 43419040431
spl id: 23f8ffed-66b2-4a97-e063-6394a90a7310
spl set id: 29d6cc8d-1469-479d-a15a-e78d4e22d4a2

Reported adverse events (FAERS/openFDA)#

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