Label: 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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 7, 2017

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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)

  • Tube Label 

    product label

  • Tube label 2

    Tube

  • Outer Label 

    tube image

  • INGREDIENTS AND APPEARANCE
    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)
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