IOPE AIR CUSHION XP  COVER VANILLA BROAD SPECTRUM SPF50PLUS- octinoxate, titanium dioxide and zinc oxide sponge 
IOPE AIR CUSHION XP  COVER BEIGE BROAD SPECTRUM SPF50PLUS- 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 Facts

ACTIVE INGREDIENTS

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

PURPOSE

Sunscreen

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

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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

DIRECTIONS

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

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

INACTIVE INGREDIENTS

WATER (MINERAL WATER), CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, METHYL METHACRYLATE CROSSPOLYMER, ALUMINUM HYDROXIDE, STEARIC ACID, PHENOXYETHANOL, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ISOSTEARIC ACID, ISOPROPYL PALMITATE, ETHYLHEXYL PALMITATE, LECITHIN, DISTEARDIMONIUM HECTORITE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ETHYLHEXYLGLYCERIN, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ADENOSINE, MANNAN, NELUMBO NUCIFERA FLOWER EXTRACT, TOCOPHERYL ACETATE, PANTHENOL, HESPERIDIN, PRUNUS MUME FRUIT EXTRACT, SILICA, CITRIC ACID, LACTIC ACID, GLYCOPROTEINS, LIPASE, CHITOSAN, FRAGRANCE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492,77491,77499)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton Cover Vanilla

IOPE

IOPE

AIR CUSHION XP
BROAD SPECTRUM SPF50+ SUNSCREEN
Net wt. 1.05 OZ. / 30 g (15 g X 2)

Principal Display Panel - 30 g Container Carton Cover Vanilla

PRINCIPAL DISPLAY PANEL - 30 g Container Carton Cover Beige

IOPE

IOPE

AIR CUSHION XP
BROAD SPECTRUM SPF50+ SUNSCREEN
Net wt. 1.05 OZ. / 30 g (15 g X 2)

Principal Display Panel - 30 g Container Carton Cover Beige
IOPE AIR CUSHION XP   COVER VANILLA BROAD SPECTRUM SPF50PLUS
octinoxate, titanium dioxide, and zinc oxide sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-382
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 
PHENYL TRIMETHICONE 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
ARBUTIN 
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
PROPANEDIOL 
BUTYLENE GLYCOL 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
PHENOXYETHANOL 
DIMETHICONE 
TRIETHOXYCAPRYLYLSILANE 
ISOSTEARIC ACID 
ISOPROPYL PALMITATE 
ETHYLHEXYL PALMITATE 
DISTEARDIMONIUM HECTORITE 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
ADENOSINE 
YEAST MANNAN 
NELUMBO NUCIFERA FLOWER 
.ALPHA.-TOCOPHEROL ACETATE 
PANTHENOL 
HESPERIDIN 
PRUNUS MUME FRUIT 
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
LACTIC ACID 
PANCRELIPASE LIPASE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-382-211 in 1 CARTON
130 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/14/2013
IOPE AIR CUSHION XP   COVER BEIGE BROAD SPECTRUM SPF50PLUS
octinoxate, titanium dioxide, and zinc oxide sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-383
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 
PHENYL TRIMETHICONE 
CYCLOMETHICONE 6 
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE 
ARBUTIN 
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE 
PROPANEDIOL 
BUTYLENE GLYCOL 
SODIUM CHLORIDE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
PHENOXYETHANOL 
DIMETHICONE 
TRIETHOXYCAPRYLYLSILANE 
ETHYLHEXYL PALMITATE 
ISOSTEARIC ACID 
ISOPROPYL PALMITATE 
DISTEARDIMONIUM HECTORITE 
GLYCERIN 
ETHYLHEXYLGLYCERIN 
EDETATE DISODIUM 
ADENOSINE 
YEAST MANNAN 
NELUMBO NUCIFERA FLOWER 
PANTHENOL 
HESPERIDIN 
.ALPHA.-TOCOPHEROL ACETATE 
PRUNUS MUME FRUIT 
SILICON DIOXIDE 
CITRIC ACID MONOHYDRATE 
LACTIC ACID 
PANCRELIPASE LIPASE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:43419-383-211 in 1 CARTON
130 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/14/2013
Labeler - AMOREPACIFIC (687995683)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC687995683MANUFACTURE(43419-382, 43419-383)

Revised: 08/2013
 
AMOREPACIFIC