IOPE Air Cushion® Intense Cover

IOPE Air Cushion® Intense Cover

Drug Labeling and Warnings

Drug Details

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IOPE AIR CUSHION INTENSE COVER 13- zinc oxide, octinoxate, and titanium dioxide lotion 
IOPE AIR CUSHION INTENSE COVER 21- zinc oxide, octinoxate, and titanium dioxide lotion 
IOPE AIR CUSHION INTENSE COVER 23- 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® Intense 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, TITANIUM DIOXIDE (CI 77891), BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PROPANEDIOL, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, ALUMINUM HYDROXIDE, IRON OXIDES (CI 77492), STEARIC ACID, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE / PARFUM, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, CAPRYLYL GLYCOL, IRON OXIDES (CI 77491), DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-3 POLYRICINOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77499), DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ADENOSINE, BUTYLENE GLYCOL, TOCOPHEROL, PHENOXYETHANOL, LACTIC ACID, PCA, GLUCOSE, GLYCINE, SILICA, SODIUM GLYCEROPHOSPHATE, UREA, SERINE, GLUTAMIC ACID, POTASSIUM MAGNESIUM ASPARTATE, ASPARTIC ACID, LEUCINE, ALANINE, LYSINE, ARGININE, CALCIUM GLUCONATE, MAGNESIUM GLUCONATE, TYROSINE, PHENYLALANINE, PROLINE, THREONINE, VALINE, ISOLEUCINE, CITRIC ACID, CHITOSAN, HISTIDINE, CYSTEINE, URIC ACID, CREATINE, ACETYL GLUCOSAMINE, METHIONINE, LIPASE

Question or comments?

http://www.iope.com/int/en/story.html

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 13 IVORY

IOPE

IOPE AIR CUSHION® INTENSE 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 - 21 VANILLA

IOPE

IOPE AIR CUSHION® INTENSE COVER 21 VANILLA
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 - 21 VANILLA

PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 23 BEIGE

IOPE

IOPE AIR CUSHION® INTENSE COVER 23 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 - 23 BEIGE
IOPE AIR CUSHION INTENSE COVER 13 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PIDOLIC ACID (UNII: SZB83O1W42)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
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)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
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: 43419-411-312 in 1 CARTON01/02/2018
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/02/2018
IOPE AIR CUSHION INTENSE COVER 21 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PIDOLIC ACID (UNII: SZB83O1W42)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
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)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
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: 43419-412-312 in 1 CARTON01/02/2018
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/02/2018
IOPE AIR CUSHION INTENSE COVER 23 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.47 g  in 15 g
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
PROPANEDIOL (UNII: 5965N8W85T)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PIDOLIC ACID (UNII: SZB83O1W42)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
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)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
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: 43419-413-312 in 1 CARTON01/02/2018
115 g in 1 CONTAINER; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/02/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC CORPORATION694894112MANUFACTURE(43419-411, 43419-412, 43419-413)

Revised: 7/2018
 
AMOREPACIFIC CORPORATION


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