PRODUCT NDC | 58443-0622 | The 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 NAME | HUMAN OTC DRUG | 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. |
PROPRIETARY NAME | Austalian Gold | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
PROPRIETARY NAME SUFFIX | Broad Spectrum SPF 50 Sunscreen | 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. |
NON PROPRIETARY NAME | Titanium Dioxide, Zinc Oxide | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
DOSAGE FORM NAME | LOTION | The translation of the dosage form Code submitted by the firm. |
ROUTE NAME | TOPICAL | The translation of the route code submitted by the firm, indicating route of administration. |
START MARKETING DATE | 12/9/2022 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
MARKETING CATEGORY NAME | OTC MONOGRAPH FINAL | 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. |
APPLICATION NUMBER | M020 | The translation of the dosage form Code submitted by the firm. |
LABELER NAME | Prime Enterprises Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
SUBSTANCE NAME | TITANIUM DIOXIDE; ZINC OXIDE | The translation of the route code submitted by the firm, indicating route of administration. |
ACTIVE NUMERATOR STRENGTH | 44; 44 | |
ACTIVE INGRED UNIT | mg/mL; mg/mL | This is the date that the labeler indicates was the start of its marketing of the drug product. |