NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA- titanium dioxide lotion NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - ESPRESSO- titanium dioxide lotion

Nu Colour Bioadaptive BB Plus Foundation - Espresso by

Drug Labeling and Warnings

Nu Colour Bioadaptive BB Plus Foundation - Espresso by is a Otc medication manufactured, distributed, or labeled by NSE Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Titanium Dioxide 5%

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 - Java

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

NU COLOUR®

NU

BIOADAPTIVE BB+
SKIN LOVING
FOUNDATION

Broad Spectrum
SPF 35

30 mL e 1 Fl Oz

INGREDIENTS AND APPEARANCE

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-3954
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
Butylene Glycol (UNII: 3XUS85K0RA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Squalane (UNII: GW89575KF9)
Pentylene Glycol (UNII: 50C1307PZG)
MICA (UNII: V8A1AW0880)
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)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Tribehenin (UNII: 8OC9U7TQZ0)
Ethylhexyl Palmitate (UNII: 2865993309)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
Stearic Acid (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
Ethylhexylglycerin (UNII: 147D247K3P)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-3954-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/03/2022

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - ESPRESSO 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62839-3953
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Squalane (UNII: GW89575KF9)
Pentylene Glycol (UNII: 50C1307PZG)
MICA (UNII: V8A1AW0880)
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)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Tribehenin (UNII: 8OC9U7TQZ0)
Ethylhexyl Palmitate (UNII: 2865993309)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
Stearic Acid (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
Ethylhexylglycerin (UNII: 147D247K3P)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62839-3953-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/03/2022

Labeler - NSE Products, Inc. (803486393)