Mamonde Brightening Cover Watery Cushion

Drug Labeling and Warnings

Drug Details [pdf]

MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 11- zinc oxide, octinoxate, and titanium dioxide lotion 
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 21- zinc oxide, octinoxate, and titanium dioxide lotion 
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 23- zinc oxide, octinoxate, and titanium dioxide lotion 
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 33- zinc oxide, octinoxate, and titanium dioxide lotion 
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 35- zinc oxide, octinoxate, and titanium dioxide lotion 
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 37- 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.

----------

Mamonde Brightening Cover Watery Cushion

Drug Facts

ACTIVE INGREDIENTS W/WPURPOSE
OCTINOXATE 6.9951%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 DICAPRY LATE/DICAPRATE, TITANIUM DIOXIDE (CI 77891), CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, ALCOHOL, NIACINAMIDE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, TRIMETHYLSILOXYSILICATE, SODIUM CHLORIDE, IRON OXIDES (CI 77492), ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, MENTHYL LACTATE, FRAGRANCE / PARFUM, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, IRON OXIDES (CI 77491), HOUTTUYNIA CORDATA EXTRACT, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77499), DISODIUM EDTA, BUTYLENE GLYCOL, NARCISSUS TAZETTA BULB EXTRACT, BHT, DIPROPYLENE GLYCOL, TOCOPHEROL, SODIUM CITRATE, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 11

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 11

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 21

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 21

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 23

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 23

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 33

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 33

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 35

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 35

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 37

Mamonde

Brightening Cover
Watery Cushion

Broad Spectrum SPF 50
Sunscreen

Net wt. 1.05 OZ. e / 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - No. 37
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 11 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-807
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) OCTINOXATE1.049 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.6225 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-807-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 21 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-808
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) OCTINOXATE1.049 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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-808-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 23 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-809
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) OCTINOXATE1.049 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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-809-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 33 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-810
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) OCTINOXATE1.049 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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-810-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 35 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-812
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) OCTINOXATE1.049 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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-812-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
MAMONDE BRIGHTENING COVER WATERY CUSHION NO. 37 
zinc oxide, octinoxate, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43419-813
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) OCTINOXATE1.049 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)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NARCISSUS TAZETTA BULB (UNII: K17762966S)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43419-813-312 in 1 CARTON01/01/201810/14/2019
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 finalpart35201/01/201810/14/2019
Labeler - AMOREPACIFIC CORPORATION (631035289)
Establishment
NameAddressID/FEIBusiness Operations
Cosvision557789645manufacture(43419-807, 43419-808, 43419-809, 43419-810, 43419-812, 43419-813)

Revised: 10/2019
 
AMOREPACIFIC CORPORATION