NDC 83276-390 Bb Oskin Broad Spectrum Spf-30
Titanium Dioxide, Octocrylene, Zinc Oxide Cream Topical

Product Information

What is NDC 83276-390?

The NDC code 83276-390 is assigned by the FDA to the product Bb Oskin Broad Spectrum Spf-30 which is a human over the counter drug product labeled by O'skin Studio Ny. The generic name of Bb Oskin Broad Spectrum Spf-30 is titanium dioxide, octocrylene, zinc oxide. The product's dosage form is cream and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 83276-390-00 5 ml in 1 packet , 83276-390-01 50.2 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code83276-390
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Bb Oskin Broad Spectrum Spf-30
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Titanium Dioxide, Octocrylene, Zinc Oxide
Product Type 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.		Human Otc Drug
Dosage FormCream - 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.
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.		O'skin Studio Ny
Labeler Code83276
FDA Application Number 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.		part352
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-27-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Bb Oskin Broad Spectrum Spf-30?


Product Packages

NDC Code 83276-390-00

Package Description: 5 mL in 1 PACKET

NDC Code 83276-390-01

Package Description: 50.2 mL in 1 BOTTLE

Product Details

What are Bb Oskin Broad Spectrum Spf-30 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Bb Oskin Broad Spectrum Spf-30 Active Ingredients UNII Codes

Bb Oskin Broad Spectrum Spf-30 Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Bb Oskin Broad Spectrum Spf-30 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Titanium dioxide 7.00%

Octocrylene 5.00%

Zinc Oxide 6.00%


Purpose



Sunscreen


Uses:



  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • if used as directed with other sun protection meassures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 or irritation develops and lasts.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions:



  • Apply liberally 15 minutes before sun exposure and as needed.
  • 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, expecially from 10 a.m.-2 p.m.
  • Wear long-sleevd shirts, pants, hats, and sunglasses.

Other Information:



  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:



Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea Butter), C12-15 Alkyl Benzoate, Caffeine, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Cocos Nucifera (Coconut) Oil, Coffea Arabica Seed Extract, Cymbopogon Flexuosus (Lemongrass) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower Oil), Hyaluronic Acid, Iron Oxides (Black, Red, White, Yellow), Lecithin, Magnesium Aluminum Silicate, Mauritia Flexuosa (Buriti) Oil, Niacinamide, Octyldodecyl Neopentanoate, Ocimum Basilicum (Basil) Extract, Sodium Polyacrylate, Sorbitan Stearate, Ubiquinone (CoQ10), Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Extract, ZIngiber Officinalis (Ginger) Oil,


Questions Or Comments?



(347-335-5540) Visit us: www.oskinstudionyc.com


Package Labeling:50.2Ml



Bottle - Bottle

Bottle - Bottle


* Please review the disclaimer below.