| PRODUCT NDC | 10345-904 | 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 | Erborian BB creme au Ginseng chocolate SPF 20 | 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 | OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| DOSAGE FORM NAME | CREAM | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| ROUTE NAME | TOPICAL | The translation of the dosage form Code submitted by the firm. |
| START MARKETING DATE | 5/1/2022 | The translation of the route code submitted by the firm, indicating route of administration. |
| MARKETING CATEGORY NAME | OTC MONOGRAPH DRUG | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| APPLICATION NUMBER | M020 | 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. |
| LABELER NAME | LABORATOIRES M&L | 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. |
| SUBSTANCE NAME | OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE | Name of Company corresponding to the labeler code segment of the Product NDC. |
| ACTIVE NUMERATOR STRENGTH | 40; 35.4; 29.4 | |
| ACTIVE INGRED UNIT | mg/mL; mg/mL; mg/mL | |
| PHARM CLASSES | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] | |