Label: BREATHABLE TINT 1- titanium dioxide and zinc oxide cream
BREATHABLE TINT 2- titanium dioxide and zinc oxide cream
BREATHABLE TINT 3- titanium dioxide and zinc oxide cream
BREATHABLE TINT 4- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51790-300-01, 51790-301-01, 51790-302-01, 51790-303-01 - Packager: Quura Medical B.V
- 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 January 9, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Actives :
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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) - Product label Almond shade
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BREATHABLE TINT 1
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51790-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 86 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 64 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color white (Titanium Dioxide) , red (Iron Oxides) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51790-300-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2017 BREATHABLE TINT 2
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51790-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 86 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 64 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color white (Titanium Dioxide) , red (Iron Oxides) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51790-301-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2017 BREATHABLE TINT 3
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51790-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 86 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 64 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color white (Titanium Dioxide) , red (IronOxides) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51790-302-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2017 BREATHABLE TINT 4
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51790-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 86 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 64 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color white (Titanium Dioxide) , red (Iron Oxides) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51790-303-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2017 Labeler - Quura Medical B.V (489419151) Registrant - Quura Medical B.V (489419151) Establishment Name Address ID/FEI Business Operations Allure Cosmetic Inc 926831603 manufacture(51790-300, 51790-301, 51790-302, 51790-302, 51790-303)
