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NDC 62839-3954-01 Nu Colour Bioadaptive BB Plus Foundation - Java 50 mg/mL Details

Nu Colour Bioadaptive BB Plus Foundation - Java 50 mg/mL

Nu Colour Bioadaptive BB Plus Foundation - Java is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	62839-3954
Product ID	62839-3954_8af5ea9b-1bee-4e7a-a265-1479b3da200f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nu Colour Bioadaptive BB Plus Foundation - Java
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	TITANIUM DIOXIDE
Labeler Name	NSE Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62839-3954-01 (62839395401)

Pricing Information	N/A
NDC Package Code	62839-3954-1
Billing NDC	62839395401
Package	1 TUBE in 1 CARTON (62839-3954-1) / 30 mL in 1 TUBE
Marketing Start Date	2022-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 92ad944f-10c8-475b-a23b-76b44f2db578 Details

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®

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 - Espresso

NU COLOUR®

BIOADAPTIVE BB+

SKIN LOVING

FOUNDATION

Broad Spectrum

SPF 35

30 mL e 1 Fl Oz

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Espresso

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 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 - ESPRESSO

titanium dioxide lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 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: 8af5ea9b-1bee-4e7a-a265-1479b3da200f

Set id: 92ad944f-10c8-475b-a23b-76b44f2db578

Version: 2

Effective Time: 20220216