NDC 55789-1221 Mineral Spf 30 Brush-on Sun Defense

Titanium Dioxide And Zinc Oxide

NDC Product Code 55789-1221

NDC CODE: 55789-1221

Proprietary Name: Mineral Spf 30 Brush-on Sun Defense 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.

Non-Proprietary Name: Titanium Dioxide And Zinc Oxide 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.

NDC Code Structure

  • 55789 - Mineral Fusion Brands
    • 55789-1221 - Mineral Spf 30 Brush-on Sun Defense

NDC 55789-1221-1

Package Description: 1 TUBE, WITH APPLICATOR in 1 CARTON > 4 g in 1 TUBE, WITH APPLICATOR

NDC Product Information

Mineral Spf 30 Brush-on Sun Defense with NDC 55789-1221 is a a human over the counter drug product labeled by Mineral Fusion Brands. The generic name of Mineral Spf 30 Brush-on Sun Defense is titanium dioxide and zinc oxide. The product's dosage form is powder and is administered via topical form.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Mineral Spf 30 Brush-on Sun Defense 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.

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.

  • MICA (UNII: V8A1AW0880)
  • NYLON-12 (UNII: 446U8J075B)

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: Mineral Fusion Brands
Labeler Code: 55789
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 12-31-2019 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 ("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".

* Please review the disclaimer below.

Mineral Spf 30 Brush-on Sun Defense Product Label Images

Mineral Spf 30 Brush-on Sun Defense 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


Drug Facts

Dist. by Mineral FusionPetaluma, CA 94954 USA

Otc - Purpose

Active IngredientsPurposeTitanium Dioxide 17.3%SunscreenZinc Oxide 20.0%Sunscreen


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


  • When using this product keep out of eyes.Rinse with water to remove.Stop use and ask doctor if rash or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.


  • Apply liberally 15 minutes before sun exposure and as needed.Children under 6 months of age: ask a doctor.

Inactive Ingredients

Mica, Silica, Nylon-12, Caprylic/Capric Triglyceride, Tocopherol, Capryloyl Glycine, Undecylenoyl Glycine, Alaria Esculenta (Sea Kelp) Extract, Retinyl Palmitate, Iron Oxides.

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.