FDA.reportPublic FDA data

Nu Colour

Manufacturer
NSE Products, Inc.
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:53:07

Label at a glance#

ProductNu Colour Bioadaptive BB Plus Foundation - Ivory
Active ingredientTitanium Dioxide
Label structure14 sections

Dosage and administration

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 inclu...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - STOP USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ivory

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL ℮ 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ivory
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ivory

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Linen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL ℮ 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Linen
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Linen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ochre

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL ℮ 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ochre
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Ochre

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Natural-Beige

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL ℮ 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Natural-Beige
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Natural-Beige

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Light-Golden

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL ℮ 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Light-Golden
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Light-Golden

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62839-3361-1Nu Colour Bioadaptive BB Plus Foundation - Light Golden30 mL in 1 TUBELOTION304
62839-3361-1Nu Colour Bioadaptive BB Plus Foundation - Light Golden1 in 1 CARTONLOTION14
62839-3362-1Nu Colour Bioadaptive BB Plus Foundation - Natural Beige30 mL in 1 TUBELOTION304
62839-3362-1Nu Colour Bioadaptive BB Plus Foundation - Natural Beige1 in 1 CARTONLOTION14
62839-3363-1Nu Colour Bioadaptive BB Plus Foundation - Ochre1 in 1 CARTONLOTION14
62839-3363-1Nu Colour Bioadaptive BB Plus Foundation - Ochre30 mL in 1 TUBELOTION304
62839-3364-1Nu Colour Bioadaptive BB Plus Foundation - Linen1 in 1 CARTONLOTION14
62839-3364-1Nu Colour Bioadaptive BB Plus Foundation - Linen30 mL in 1 TUBELOTION304
62839-3365-1Nu Colour Bioadaptive BB Plus Foundation - Ivory1 in 1 CARTONLOTION14
62839-3365-1Nu Colour Bioadaptive BB Plus Foundation - Ivory30 mL in 1 TUBELOTION304

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62839-336562839-3365-1
62839-336462839-3364-1
62839-336362839-3363-1
62839-336262839-3362-1
62839-336162839-3361-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 5 · 200 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
Phenyl TrimethiconeDR0K5NOJ4RIACT
Dimethicone92RU3N3Y1OIACT
Butylene Glycol Dicaprylate/Dicaprate75D21FL1PIIACT
MICAV8A1AW0880IACT
Butylene Glycol3XUS85K0RAIACT
Butyloctyl Salicylate2EH13UN8D3IACT
SqualaneGW89575KF9IACT
Pentylene Glycol50C1307PZGIACT
Hexyl Laurate4CG9F9W01QIACT
GlycerinPDC6A3C0OXIACT
Polyglyceryl-4 Isostearate820DPX33S7IACT
Magnesium Stearate70097M6I30IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
Disteardimonium HectoriteX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PhenoxyethanolHIE492ZZ3TIACT
Sorbitan Sesquioleate0W8RRI5W5AIACT
Tribehenin8OC9U7TQZ0IACT
Ethylhexyl Palmitate2865993309IACT
Stearic Acid4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
Hydrogenated Olive Oil UnsaponifiablesB8MIX97W95IACT
ALUMINUM OXIDELMI26O6933IACT
TriethoxycaprylylsilaneLDC331P08EIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
Aluminum Hydroxide5QB0T2IUN0IACT
Ethylhexylglycerin147D247K3PIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ROSA X DAMASCENA FLOWERJWB78P295AIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
COCOAD9108TZ9KGIACT
Trihydroxystearin06YD7896S3IACT
Propanediol5965N8W85TIACT
1,2-HexanediolTR046Y3K1GIACT
STANNIC OXIDEKM7N50LOS6IACT
HYALURONATE SODIUMYSE9PPT4THIACT
KONJAC MANNAN36W3E5TAMGIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
ndc (package): 62839-3362-1
ndc (package): 62839-3365-1
ndc (package): 62839-3364-1
ndc (package): 62839-3363-1
ndc (package): 62839-3361-1
ndc (product): 62839-3364
ndc (product): 62839-3361
ndc (product): 62839-3365
ndc (product): 62839-3363
ndc (product): 62839-3362
ndc11 (package): 62839336501
ndc11 (package): 62839336101
ndc11 (package): 62839336301
ndc11 (package): 62839336201
ndc11 (package): 62839336401
spl id: 4c8e1026-d8e2-4ed1-890b-310106dbef4c
spl set id: faae6f47-19f3-41cb-8e0d-388569b5c73d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.