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Product NDC Code | 76151-231 | ||||
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Drug Name | Boscia b.b. light broad spectrum spf 27 pa self-adjusting shade |
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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 Ingredients Titanium Dioxide 11.25% Zinc Oxide 0.98%
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 Water/Aqua/Eau, Cyclopentasiloxane, Dipropylene Glycol, Dimethicone, Glycereth-26, Sodium PCA, Lactobacillus Ferment, Butylene Glycol, Glycerin, Arbutin, Beta-Glucan, Dipotassium Glycyrrhizate, Simmondsia Chinensis (Jojoba) Seed Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Alteromonas Ferment Extract, Yeast Extract, Sodium Hyaluronate, Allantoin, Adenosine, Panthenol, Stearic Acid, PEG/PPG 20/15 Dimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, Dimethicone PEG-10/15 Crosspolymer, Acrylate/Dimethicone Copolymer, Triethoxycaprylylsilane, Phenyl Trimethicone, Sorbitol, Alumina, Mica, Caprylyl Glycol, Iron Oxide (CI 77491, CI77492, CI77499)
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 ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see 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 B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE FERRIC OXIDE RED WATER CYCLOMETHICONE 5 DIPROPYLENE GLYCOL GLYCERETH-26 SODIUM PYRROLIDONE CARBOXYLATE BUTYLENE GLYCOL GLYCERIN ARBUTIN SIMMONDSIA CHINENSIS SEED EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP YEAST ALLANTOIN ADENOSINE PANTHENOL STEARIC ACID PEG/PPG-20/15 DIMETHICONE TRIETHOXYCAPRYLYLSILANE PHENYL TRIMETHICONE SORBITOL ALUMINUM OXIDE MICA CAPRYLYL GLYCOL TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
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 B.B. Cream Light Broad Spectrum SPF 27 PA++ Oil-free Self-adjusting shade for all skin types 1.75oz/50 g
Product Labels Inner 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 B.B. Cream LIGHT Broad Spectrum SPF 27 PA Oil-Free Self-Adjusting Shade
Other information protect this product from excessive heat and direct sun
This one-step wonder creates a lustrous, flawless finish as it hydrates, firms and soothes the skin. Helps diminish the appearance of pores, fine lines and uneven skintone while providing long-wearing, natural coverage that conceals imperfections. , a naturally-derived survival mollucule. shields and soothes skin. provides essential moisture and protects against environmental damage. , a powerful antioxidant derived from bearberry, helps brighten hyperpigmentation and reduces fine lines and wrinkles. . Artificial fragrance and color free. Gluten-free. Ethanol alcohol-free. Dermatologist tested. B210-20 Distributed by boscia, LLC. Irvine, CA 92614 Made in U.S.A e Abyssin Beta-Glucan Arbutin Preservative-free www.boscia.net
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