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 
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® Cover

Drug Facts

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

USE

  • 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

When using this product

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

Do not use on

  • damaged or broken skin.

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 / 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.

PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 21 Vanilla

REFILL

IOPE

AIR CUSHION®

COVER

21 VANILLA

BROAD SPECTRUM
SPF 50+ SUNSCREEN

Net wt. 0.52 OZ. / 15 g

Cut here

PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 21 Vanilla

PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 23 Beige

REFILL

IOPE

AIR CUSHION®

COVER

23 BEIGE

BROAD SPECTRUM
SPF 50+ SUNSCREEN

Net wt. 0.52 OZ. / 15 g

Cut here

PRINCIPAL DISPLAY PANEL - 15 g Container Pouch - 23 Beige
IOPE AIR CUSHION COVER 21 VANILLA 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-404
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PROPANEDIOL (UNII: 5965N8W85T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
TREHALOSE (UNII: B8WCK70T7I)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PIDOLIC ACID (UNII: SZB83O1W42)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
GLYCINE (UNII: TE7660XO1C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
UREA (UNII: 8W8T17847W)  
SODIUM GLYCEROPHOSPHATE (UNII: RCS9EQ01V4)  
SERINE (UNII: 452VLY9402)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
POTASSIUM MAGNESIUM ASPARTATE (UNII: 55TUI7Q42I)  
LEUCINE (UNII: GMW67QNF9C)  
ALANINE (UNII: OF5P57N2ZX)  
LYSINE (UNII: K3Z4F929H6)  
ARGININE (UNII: 94ZLA3W45F)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
TYROSINE (UNII: 42HK56048U)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
PROLINE (UNII: 9DLQ4CIU6V)  
THREONINE (UNII: 2ZD004190S)  
VALINE (UNII: HG18B9YRS7)  
ISOLEUCINE (UNII: 04Y7590D77)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HISTIDINE (UNII: 4QD397987E)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
CREATINE (UNII: MU72812GK0)  
URIC ACID (UNII: 268B43MJ25)  
CYSTEINE (UNII: K848JZ4886)  
METHIONINE (UNII: AE28F7PNPL)  
PANCRELIPASE LIPASE (UNII: 8MYC33932O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-404-341 in 1 POUCH01/10/201810/01/2018
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 FINALpart35201/10/201810/01/2018
IOPE AIR CUSHION COVER 23 BEIGE 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PROPANEDIOL (UNII: 5965N8W85T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
TREHALOSE (UNII: B8WCK70T7I)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PIDOLIC ACID (UNII: SZB83O1W42)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
GLYCINE (UNII: TE7660XO1C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
UREA (UNII: 8W8T17847W)  
SODIUM GLYCEROPHOSPHATE (UNII: RCS9EQ01V4)  
SERINE (UNII: 452VLY9402)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
POTASSIUM MAGNESIUM ASPARTATE (UNII: 55TUI7Q42I)  
LEUCINE (UNII: GMW67QNF9C)  
ALANINE (UNII: OF5P57N2ZX)  
LYSINE (UNII: K3Z4F929H6)  
ARGININE (UNII: 94ZLA3W45F)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
TYROSINE (UNII: 42HK56048U)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
PROLINE (UNII: 9DLQ4CIU6V)  
THREONINE (UNII: 2ZD004190S)  
VALINE (UNII: HG18B9YRS7)  
ISOLEUCINE (UNII: 04Y7590D77)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HISTIDINE (UNII: 4QD397987E)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
CREATINE (UNII: MU72812GK0)  
URIC ACID (UNII: 268B43MJ25)  
CYSTEINE (UNII: K848JZ4886)  
METHIONINE (UNII: AE28F7PNPL)  
PANCRELIPASE LIPASE (UNII: 8MYC33932O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-405-341 in 1 POUCH01/10/201810/01/2018
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 FINALpart35201/10/201810/01/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)

Revised: 10/2018
 
AMOREPACIFIC CORPORATION