NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - IVORY- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LINEN- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - OCHRE- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - NATURAL BEIGE- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LIGHT GOLDEN- titanium dioxide lotion
NSE Products, Inc.

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.

----------

Nu Colour® Bioadaptive BB+ Foundation

Drug Facts

Active Ingredient

Titanium Dioxide 12%

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 - Ivory

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 - Linen

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 - Ochre

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 - Natural-Beige

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 - Light-Golden

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

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - IVORY
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-3365
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
MICA (UNII: V8A1AW0880)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Squalane (UNII: GW89575KF9)
Pentylene Glycol (UNII: 50C1307PZG)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Glycerin (UNII: PDC6A3C0OX)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Magnesium Stearate (UNII: 70097M6I30)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
ALUMINUM OXIDE (UNII: LMI26O6933)
Triethoxycaprylylsilane (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Ethylhexylglycerin (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-3365-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

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

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LINEN
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-3364
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
Butylene Glycol (UNII: 3XUS85K0RA)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
ALUMINUM OXIDE (UNII: LMI26O6933)
Triethoxycaprylylsilane (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-3364-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

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

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - OCHRE
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-3363
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
MICA (UNII: V8A1AW0880)
Butylene Glycol (UNII: 3XUS85K0RA)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Stearic Acid (UNII: 4ELV7Z65AP)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
Triethoxycaprylylsilane (UNII: LDC331P08E)
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 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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-3363-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

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

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - NATURAL BEIGE
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-3362
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)
MICA (UNII: V8A1AW0880)
Butylene Glycol (UNII: 3XUS85K0RA)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Stearic Acid (UNII: 4ELV7Z65AP)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
Triethoxycaprylylsilane (UNII: LDC331P08E)
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 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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-3362-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

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

NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LIGHT GOLDEN
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-3361
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	120 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
Hydrogenated Olive Oil Unsaponifiables (UNII: B8MIX97W95)
ALUMINUM OXIDE (UNII: LMI26O6933)
Triethoxycaprylylsilane (UNII: LDC331P08E)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-3361-1	1 in 1 CARTON	02/03/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - NSE Products, Inc. (803486393)

Revised: 2/2022

Document Id: 273b9f76-265a-4890-ad4d-47269694dcc8

Set id: faae6f47-19f3-41cb-8e0d-388569b5c73d

Version: 2

Effective Time: 20220217

NSE Products, Inc.