Label: NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - CREAM- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - MEDIUM OCHRE- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - BEIGE- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - MEDIUM BEIGE- titanium dioxide lotion

  • NDC Code(s): 62839-3360-1, 62839-3950-1, 62839-3958-1, 62839-3959-1
  • Packager: NSE Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 February 16, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 13%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn.
    • Higher SPF gives more sun protection.
    • 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.
    • Smooth over face and neck, blending well. Seal with powder if desired.
  • Warnings

    • For external use only.

    • Do not use on damaged or broken skin.

    • Stop use and ask a doctor if a rash occurs.

    • When using this product, keep out of eyes.
    • Rinse with water to remove.

    • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor
    • 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 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.
  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    Water (Aqua), Phenyl Trimethicone, Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Butylene Glycol, Acrylates Copolymer, Butyloctyl Salicylate, Squalane, Cetyl PEG/PPG- 10/1 Dimethicone, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Glycerin, Polyglyceryl-4 Isostearate, Magnesium Stearate, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Tribehenin, Sorbitan Sesquioleate, Ethylhexyl Palmitate, Triethoxycaprylylsilane, Stearic Acid, Hydrogenated Olive Oil Unsaponifiables, Alumina, Methyl Methacrylate Crosspolymer, Synthetic Fluorphlogopite, Aluminum Hydroxide, Ethylhexylglycerin, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Seed Extract, Rosa Damascena Flower Extract, Saccharomyces Ferment Filtrate, Trihydroxystearin, Glucomannan, Propanediol, 1,2-Hexanediol, Tin Oxide, Disodium EDTA, Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499).

  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Cream

    NU COLOUR®

    NU

    BIOADAPTIVE BB+
    SKIN LOVING
    FOUNDATION

    Broad Spectrum
    SPF 35

    30 mL e 1 Fl Oz

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Cream
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium Ochre

    NU COLOUR®

    NU

    BIOADAPTIVE BB+
    SKIN LOVING
    FOUNDATION

    Broad Spectrum
    SPF 35

    30 mL e 1 Fl Oz

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium Ochre
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Beige

    NU COLOUR®

    NU

    BIOADAPTIVE BB+
    SKIN LOVING
    FOUNDATION

    Broad Spectrum
    SPF 35

    30 mL e 1 Fl Oz

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Beige
  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium Beige

    NU COLOUR®

    NU

    BIOADAPTIVE BB+
    SKIN LOVING
    FOUNDATION

    Broad Spectrum
    SPF 35

    30 mL e 1 Fl Oz

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium Beige
  • INGREDIENTS AND APPEARANCE
    NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - CREAM 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-3958
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide130 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Mica (UNII: V8A1AW0880)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Squalane (UNII: GW89575KF9)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCOA (UNII: D9108TZ9KG)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Propanediol (UNII: 5965N8W85T)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3958-11 in 1 CARTON02/03/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/03/2022
    NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - MEDIUM OCHRE 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-3959
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide130 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Squalane (UNII: GW89575KF9)  
    MICA (UNII: V8A1AW0880)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCOA (UNII: D9108TZ9KG)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Propanediol (UNII: 5965N8W85T)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3959-11 in 1 CARTON02/03/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/03/2022
    NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - BEIGE 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-3360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide130 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Squalane (UNII: GW89575KF9)  
    MICA (UNII: V8A1AW0880)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCOA (UNII: D9108TZ9KG)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Propanediol (UNII: 5965N8W85T)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3360-11 in 1 CARTON02/03/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/03/2022
    NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - MEDIUM BEIGE 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-3950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide130 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Squalane (UNII: GW89575KF9)  
    MICA (UNII: V8A1AW0880)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COCOA (UNII: D9108TZ9KG)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Propanediol (UNII: 5965N8W85T)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-3950-11 in 1 CARTON02/03/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/03/2022
    Labeler - NSE Products, Inc. (803486393)