Label: NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA- titanium dioxide lotion
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - ESPRESSO- titanium dioxide lotion
- NDC Code(s): 62839-3953-1, 62839-3954-1
- Packager: NSE Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
-
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
-
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?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Java
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Espresso
-
INGREDIENTS AND APPEARANCE
NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - JAVA
titanium dioxide lotionProduct 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 lotionProduct 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)
