IOPE AIR CUSHION XP- octinoxate, titanium dioxide and zinc oxide sponge 
AMOREPACIFIC

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.

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Drug Fact

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%, TITANIUM DIOXIDE 4.15%, ZINC OXIDE 9.8%

PURPOSE

Sunscreen

USE

helps prevent sunburn

WARNINGS

For external use only.

When using this product

- Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

- Rash or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply smoothly before sun exposure and as needed. Children under 6 months of age : ask a doctorhs of age : ask a doctor.

INACTIVE INGREDIENTS

WATER (MINERAL WATER), CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL, DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, DISTEARDIMONIUM HECTORITE, PHENOXYETHANOL, STEARIC ACID, METHYL METHACRYLATE CROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-11, ISOSTEARIC ACID, ETHYLHEXYL PALMITATE, LECITHIN, ISOPROPYL PALMITATE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYLHEXYLGLYCERIN, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ADENOSINE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, NELUMBO NUCIFERA FLOWER EXTRACT, TOCOPHERYL ACETATE, PANTHENOL, HESPERIDIN, PRUNUS MUME FRUIT EXTRACT, SILICA, CITRIC ACID, LACTIC ACID, GLYCOPROTEINS, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77492, CI 77491, CI 77499)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - Ice Vanilla

IOPE

IOPE

AIR CUSHION XP

Principal Display Panel - 30 g Container Carton - Ice Vanilla

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - Ice Beige

IOPE

IOPE

AIR CUSHION XP

Principal Display Panel - 30 g Container Carton - Ice Beige
IOPE AIR CUSHION XP 
octinoxate, titanium dioxide, and zinc oxide sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-380
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.245 g  in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
PROPYLENE GLYCOL 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
ARBUTIN 
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
PROPANEDIOL 
BUTYLENE GLYCOL 
DIMETHICONE 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
DISTEARDIMONIUM HECTORITE 
PHENOXYETHANOL 
STEARIC ACID 
TRIETHOXYCAPRYLYLSILANE 
ISOSTEARIC ACID 
ETHYLHEXYL PALMITATE 
ISOPROPYL PALMITATE 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
ADENOSINE 
NELUMBO NUCIFERA FLOWER 
.ALPHA.-TOCOPHEROL ACETATE 
PANTHENOL 
HESPERIDIN 
PRUNUS MUME FRUIT 
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
LACTIC ACID 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-380-211 in 1 CARTON
130 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/12/2013
IOPE AIR CUSHION XP 
octinoxate, titanium dioxide, and zinc oxide sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-381
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.245 g  in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2.94 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PHENYL TRIMETHICONE 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
PROPYLENE GLYCOL 
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
ARBUTIN 
PROPANEDIOL 
BUTYLENE GLYCOL 
DIMETHICONE 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
DISTEARDIMONIUM HECTORITE 
PHENOXYETHANOL 
STEARIC ACID 
TRIETHOXYCAPRYLYLSILANE 
ISOPROPYL PALMITATE 
ISOSTEARIC ACID 
ETHYLHEXYL PALMITATE 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
ADENOSINE 
NELUMBO NUCIFERA FLOWER 
.ALPHA.-TOCOPHEROL ACETATE 
HESPERIDIN 
PANTHENOL 
PRUNUS MUME FRUIT 
SILICON DIOXIDE 
LACTIC ACID 
CITRIC ACID MONOHYDRATE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-381-211 in 1 CARTON
130 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/12/2013
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE(43419-380, 43419-381)

Revised: 04/2013
Document Id: 3f7d6077-09f5-4e27-b802-67a21c876bbc
Set id: 4b103ac1-0f6a-43ce-b53a-413ebb4a9a9b
Version: 1
Effective Time: 20130415
 
AMOREPACIFIC