BREATHABLE CONCEALER LIGHT- titanium dioxide and zinc oxide cream 
BREATHABLE CONCEALER MEDIUM- titanium dioxide and zinc oxide cream 
BREATHABLE CONCEALER TAN- titanium dioxide and zinc oxide cream 
Quura Medical B.V

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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Actives :

Titanium Dioxide
Zinc Oxide

Inactives

Cyclopentasiloxane,Zinc Oxide,Dimethicone,Titanium Dioxide,Bismuth Oxychloride,Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone
Water (Aqua),Mica,Dimethicone/PEG-10/15 Crosspolymer,Hydroxypropylcocoate PEG-8 Dimethicone,Polyglyceryl-2 Diisostearate, Stearic Acid,Aluminum Hydroxide,Dimethicone/Vinyl Dimethicone Crosspolymer,Glycerin,Saccharomyces Lysate Extract,Cyclotetrasiloxane,Cyclohexasiloxane,Sodium Hyaluronate,Santalum Album (Sandalwood) Extract,Algae Extract,Centella Asiatica Extract,Artemisia Vulgaris Extract,Isohexadecane,Hydrated Silica,Malus Domestica Fruit Cell Culture,Hordeum Distichon (Barley) Extract,Lonicera Japonica (Honeysuckle) Flower Extract,PEG/PPG-18/18 Dimethicone,Xanthan Gum,Lecithin,Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone,Cyperus Rotundus Root Extract,Xanthium Sibiricum Fruit Extract,Phospholipids ,Olea Europaea (Olive) Leaf Extract,Mannitol,Sodium Benzoate,Ascorbyl Palmitate,Retinyl Palmitate,Squalane,Zinc PCA,Sodium Citrate,Acetyl Tetrapeptide-15,Tocopherol,Triethoxycaprylylsilane,Phellodendron Amurense Bark Extract,Beta-Carotene,Phenoxyethanol,Ethylhexylglycerin,Hexylene Glycol, Caprylyl Glycol,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Titanium Dioxide (CI 77891)

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BREATHABLE CONCEALER LIGHT 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51790-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION86 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SANDALWOOD (UNII: 3641YW25N2)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
APPLE (UNII: B423VGH5S9)  
BARLEY (UNII: 5PWM7YLI7R)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
XANTHIUM SIBIRICUM WHOLE (UNII: H05ZV0N61A)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SQUALANE (UNII: GW89575KF9)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
Colorwhite (Titanium Dioxide) , red (FERRIC OXIDE RED) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51790-100-017.4 mL in 1 TUBE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/07/2017
BREATHABLE CONCEALER MEDIUM 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51790-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION86 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SANDALWOOD (UNII: 3641YW25N2)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
APPLE (UNII: B423VGH5S9)  
BARLEY (UNII: 5PWM7YLI7R)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
XANTHIUM SIBIRICUM WHOLE (UNII: H05ZV0N61A)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SQUALANE (UNII: GW89575KF9)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
Colorwhite (Titanium Dioxide) , red (FERRIC OXIDE RED) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51790-101-017.4 mL in 1 TUBE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/07/2017
BREATHABLE CONCEALER TAN 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51790-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION86 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
WATER (UNII: 059QF0KO0R)  
MICA (UNII: V8A1AW0880)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SANDALWOOD (UNII: 3641YW25N2)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
APPLE (UNII: B423VGH5S9)  
BARLEY (UNII: 5PWM7YLI7R)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
XANTHIUM SIBIRICUM WHOLE (UNII: H05ZV0N61A)  
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SQUALANE (UNII: GW89575KF9)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
Colorwhite (Titanium Dioxide) , red (FERRIC OXIDE RED) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51790-102-017.4 mL in 1 TUBE; Type 0: Not a Combination Product12/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/07/2017
Labeler - Quura Medical B.V (489419151)
Establishment
NameAddressID/FEIBusiness Operations
Allure Cosmetic Inc.926831603manufacture(51790-100, 51790-101, 51790-102)

Revised: 12/2017
Document Id: 16d9a260-2d36-46fc-b5d5-a0e66d2c6a04
Set id: 0c0f8b33-debb-4806-abd4-c2ac4a3bbb74
Version: 1
Effective Time: 20171207
 
Quura Medical B.V