IOPE AIR CUSHION XP  NATURAL 31- octinoxate, titanium dioxide, and zinc oxide lotion 
Amorepacific Corporation

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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IOPE AIR CUSHION XP NATURAL 31

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, CYCLOHEXASILOXANE, PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ARBUTIN, PROPANEDIOL, BUTYLENE GLYCOL, DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, PHENOXYETHANOL, POLYSILICONE-11, TRIETHOXYCAPRYLYLSILANE, ISOPROPYL PALMITATE, ISOSTEARIC ACID, LECITHIN, ETHYLHEXYL PALMITATE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, METHYL METHACRYLATE CROSSPOLYMER, ADENOSINE, NELUMBO NUCIFERA FLOWER EXTRACT, HESPERIDIN, TOCOPHERYL ACETATE, PANTHENOL, 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

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
IOPE AIR CUSHION XP  NATURAL 31
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-384
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
ARBUTIN (UNII: C5INA23HXF)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ADENOSINE (UNII: K72T3FS567)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
HESPERIDIN (UNII: E750O06Y6O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PANTHENOL (UNII: WV9CM0O67Z)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
PANCRELIPASE LIPASE (UNII: 8MYC33932O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-384-212 in 1 CARTON06/12/201310/01/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/12/201310/01/2018
Labeler - Amorepacific Corporation (631035289)

Revised: 10/2018
 
Amorepacific Corporation