Label: IOPE AIR CUSHION COVER 13 IVORY- zinc oxide, octinoxate, and titanium dioxide lotion
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
IOPE AIR CUSHION COVER 31 WARM BEIGE- zinc oxide, octinoxate, and titanium dioxide lotion

  • NDC Code(s): 43419-403-31, 43419-404-31, 43419-405-31, 43419-414-31
  • Packager: AMOREPACIFIC CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 29, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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 , METHYL METHACRYLATE CROSSPOLYMER , GLYCERIN , ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER , POLYHYDROXYSTEARIC ACID , SODIUM CHLORIDE , ALUMINUM HYDROXIDE , IRON OXIDES (CI 77492) , 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 , RON 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 Carton - 13 Ivory

    IOPE

    AIR CUSHION ® 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

    AIR CUSHION ® 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

    AIR CUSHION ® 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
  • PRINCIPAL DISPLAY PANEL - 15 g Container Carton - 31 Warm Beige

    IOPE

    IOPE AIR CUSHION ® COVER 31 WARM 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 - 31 Warm Beige
  • INGREDIENTS AND APPEARANCE
    IOPE AIR CUSHION COVER 13 IVORY 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-403
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-403-312 in 1 CARTON06/05/201702/29/2024
    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 finalpart35212/26/201602/29/2024
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-404-312 in 1 CARTON06/05/2017
    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 finalpart35212/26/2016
    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
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-405-312 in 1 CARTON06/05/2017
    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 finalpart35212/26/2016
    IOPE AIR CUSHION COVER 31 WARM BEIGE 
    zinc oxide, octinoxate, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-414
    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)  
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PIDOLIC ACID (UNII: SZB83O1W42)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-414-312 in 1 CARTON09/20/201803/21/2021
    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 finalpart35209/20/201803/21/2021
    Labeler - AMOREPACIFIC CORPORATION (631035289)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMOREPACIFIC CORPORATION694894112manufacture(43419-403, 43419-404, 43419-405, 43419-414)