Drug Information

  • Product NDC: 58274-007
  • Proprietary Name: Brush on Block Mineral Sunscreen Broad Spectrum SPF 30
  • Non Proprietary Name: Titanium Dioxide 15%, Zinc Oxide 12%
  • Active Ingredient(s): 15 g/100g TITANIUM DIOXIDE; 12 g/100g ZINC OXIDE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): POWDER
  • Pharmacy Class(es): Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]/li>

Labeler Information

Field Name Field Value
Labeler Name: SPF Ventures, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: part352
Start Marketing Date:10/15/2015

Package Information

No. Package Code Package Description Billing Unit
158274-007-011 TUBE in 1 BOX (58274-007-01) / 3.4 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC58274-007The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEBrush on Block Mineral Sunscreen Broad Spectrum SPF 30The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETitanium Dioxide 15%, Zinc Oxide 12%The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/15/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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.
APPLICATION NUMBERpart352This 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.
LABELER NAMESPF Ventures, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETITANIUM DIOXIDE; ZINC OXIDEAn 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.
ACTIVE INGRED UNITg/100g; g/100g 
PHARM CLASSESCopper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] 

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This page was last updated on: 5/3/2024