NDC 76151-210 Boscia Bb Spf 27 Pa

Titanium Dioxide

NDC Product Code 76151-210

NDC 76151-210-01

Package Description: 50 g in 1 BOTTLE

NDC 76151-210-95

Package Description: 10 g in 1 BOTTLE

NDC Product Information

Boscia Bb Spf 27 Pa with NDC 76151-210 is a a human over the counter drug product labeled by Boscia Llc. The generic name of Boscia Bb Spf 27 Pa is titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Boscia Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Boscia Bb Spf 27 Pa Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TITANIUM DIOXIDE 6.4 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • ARBUTIN (UNII: C5INA23HXF)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • MICA (UNII: V8A1AW0880)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM ANISATE (UNII: F9WFJ28MV9)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Boscia Llc
Labeler Code: 76151
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-11-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Boscia Bb Spf 27 Pa Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients                    Purpose


Titanium Dioxide 6.4%          Sunscreen

Otc - Purpose

Use  Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warnings

Warnings  For external use only. Use as directed.

Otc - When Using

Avoid direct contact with eyes. If contact occurs, rinse gently with water.

Otc - Stop Use

Discontinue use and consult a physician immediately if any adverse reaction occurs.

Otc - Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Other Safety Information

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions  Apply in AM to cleansed and toned face as last skincare step. Reapply as needed or after towel drying, swimming or perspiring.

Other

Other Information: Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredient

Inactive Ingredients: Water, Cyclopentasiloxane, Glycerin, Sodium PCA, Glycereth-26, Dimethicone, Dipropylene Glycol, Arbutin, Beta-Glucan, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone/Vinyl Dimethicone Crosspolymer, Methylsilanol Hydroxyproline Aspartate, Panthenol, Alteromonas Ferment Extract, Phenyl Trimethicone, Acrylates/Dimethicone Copolymer, PEG-10 Dimethicone, Sodium Hyaluronate, Allantoin Adehosine, Dipotassium Glycyrihizate, Butylene Glycol, Stearic Acid, Caprylyl Glycol, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Alumina, Mica, Citric Acid, Sodium Chloride, Sodium Levulinate, Sodium Anisate, Iron Oxide (C.I. 77499), Iron Oxide (C.I. 77491), Iron Oxide (C.I. 77492)

Description

This B.B. Cream 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 coveage that conceals imperfections. Abyssine, a naturally-derived survival molecule, shields and soothes skin while Hydroxyprolisilane promotes skin elasticity and reduces the appearance of fine lines. Beta-Glucon provides essential moisture and protects against environmental damage.Preservative-free. Dermatologist tested.  Alcohol-free, pH balanced, 100% artificial fragrance and color free. No animal testing and no animal ingredients.  www.boscia.net  B210-01  Distributed by  boscia, LLC. Irvine, CA 92614  Made in U.S.A.  B11-1

* Please review the disclaimer below.