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NDC 62839-3955-01 Nu Colour Bioadaptive BB Plus Foundation - Chestnut 80 mg/mL Details
Nu Colour Bioadaptive BB Plus Foundation - Chestnut 80 mg/mL
Nu Colour Bioadaptive BB Plus Foundation - Chestnut 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 | 62839-3955 |
|---|---|
| Product ID | 62839-3955_59773b2f-d732-4a50-a163-50d1d43522d7 |
| 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 - Chestnut |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium Dioxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 80 |
| 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 62839-3955-01 (62839395501)
| NDC Package Code | 62839-3955-1 |
|---|---|
| Billing NDC | 62839395501 |
| Package | 1 TUBE in 1 CARTON (62839-3955-1) / 30 mL in 1 TUBE |
| Marketing Start Date | 2022-02-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f9479bd8-c250-4594-a134-57ac2241cf42 Details
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.
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).
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - CHESTNUT
titanium dioxide lotion |
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| Labeler - NSE Products, Inc. (803486393) |
Revised: 2/2022
Document Id: 59773b2f-d732-4a50-a163-50d1d43522d7
Set id: f9479bd8-c250-4594-a134-57ac2241cf42
Version: 2
Effective Time: 20220216