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Product NDC Code | 76151-261 | ||||
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Drug Name | Boscia all in one b.b. eye brightener broad spectrum spf 20 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Boscia LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Titanium Dioxide 6.45% Purpose Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Optional: apply to all skin exposed to the sun 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: Sun Protection Measures. limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: 1,2-Hexanediol, Algae Extract, Allantoin, Alumina, Arginine, Bakuchiol, Butylene Glycol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Caprylyl Methicone, Carbomer, Cetyl PEG/PPG-10/1 Dimethicone, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipeptide-2, Dipotassium Glycyrrhizate, Disteardimonium Hectorite, Epilobium Angustifolium Extract, Glycereth-26, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hesperidin Methyl Chalcone, Hydroxyethylcelluose, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isopropyl Titanium Triisostearate, Lactobacillus Ferment, Methicone, Mica, Neopentyl Glycol Dicaprate, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Panthenol, PEG/PPG-20/15 Dimethicone, PEG-10 Dimethicone, Polypropylsilsesquioxane, Polysorbate 20, Salicornia Herbacea Extract, Silica, Simmondsia Chinensis (Jojoba) Seed Extract, Sodium Chloride, Sodium PCA, Steareth-20, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Undaria Pinnatifida Extract, Water/Aqua/Eau
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses helps prevent sunburn if used as directed with other sun protection measures (see decreases the risk of skin cancer and early skin aging caused by the sun. Directions),
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 TITANIUM DIOXIDE 1,2-HEXANEDIOL ALLANTOIN ALUMINUM OXIDE ARGININE BAKUCHIOL BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CAPRYLYL TRISILOXANE CITRUS AURANTIUM FLOWER CYCLOMETHICONE 5 DIMETHICONE VALYLTRYPTOPHAN GLYCYRRHIZINATE DIPOTASSIUM DISTEARDIMONIUM HECTORITE GLYCERETH-26 GLYCERIN SUNFLOWER OIL HESPERIDIN METHYLCHALCONE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ISOPROPYL TITANIUM TRIISOSTEARATE MICA NEOPENTYL GLYCOL DICAPRATE PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 PANTHENOL PEG/PPG-20/15 DIMETHICONE POLYSORBATE 20 SALICORNIA EUROPAEA SILICON DIOXIDE SIMMONDSIA CHINENSIS SEED SODIUM CHLORIDE SODIUM PYRROLIDONE CARBOXYLATE STEARETH-20 .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE UNDARIA PINNATIFIDA WATER TITANIUM DIOXIDE TITANIUM DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 16g (76151-261-01) Bottle Label Outer Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20
Other information protect this product from excessive heat and direct sun
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-888-635-8884
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API