FDA.reportPublic FDA data

Nu Colour Bioadaptive BB Plus Foundation - Espresso

Manufacturer
NSE Products, Inc.
Effective date
2025-01-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:43:35

Label at a glance#

ProductNu Colour Bioadaptive BB Plus Foundation - Java
Active ingredientTitanium Dioxide
Label structure11 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 5%

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 - Java

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Espresso

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62839-3953NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - ESPRESSO (TITANIUM DIOXIDE) LOTION [NSE PRODUCTS, INC.]3Legacy NDC20250105_92ad944f-10c8-475b-a23b-76b44f2db578.zip
62839-3954NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - ESPRESSO (TITANIUM DIOXIDE) LOTION [NSE PRODUCTS, INC.]3Legacy NDC20250105_92ad944f-10c8-475b-a23b-76b44f2db578.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62839-395462839-3954-1
62839-395362839-3953-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 78 matching rows.

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

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
cae05689-8368-4106-bed5-d24e4a8e29a892ad944f-10c8-475b-a23b-76b44f2db5782026-03-20WarningsExact identifier
spl set id: 92ad944f-10c8-475b-a23b-76b44f2db578

Reported adverse events (FAERS/openFDA)#

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