64141-034 NDC - OCTINOXATE, TITANIUM DIOXIDE

Drug Information

Product NDC: 64141-034

Proprietary Name:

Non Proprietary Name: octinoxate, titanium dioxide

Active Ingredient(s):
  • 67 mg/mL OCTINOXATE;
  • 17 mg/mL TITANIUM DIOXIDE


Administration Route(s):

Dosage Form(s): EMULSION

Labeler Information

Labeler Name: Bobbi Brown Professional Cosmetics Inc.
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:10/11/2023

Package Information

No. Package Code Package Description Billing Unit
164141-034-00200000 mL in 1 DRUM (64141-034-00)
264141-034-011 BOTTLE in 1 CARTON (64141-034-01) / 30 mL in 1 BOTTLE
364141-034-021 BOTTLE in 1 CARTON (64141-034-02) / 13 mL in 1 BOTTLE
464141-034-901000 mL in 1 PAIL (64141-034-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC64141-034The 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.
NON PROPRIETARY NAMEOCTINOXATE, TITANIUM DIOXIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEEMULSIONThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE5/16/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH 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.
LABELER NAMEBobbi Brown Professional Cosmetics Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEOCTINOXATE; TITANIUM DIOXIDEAn 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 NUMERATOR STRENGTH67; 17 
ACTIVE INGRED UNITmg/mL; mg/mL 
PRODUCT NDC64141-034The 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 NAMEDRUG FOR FURTHER PROCESSINGIndicates 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 NAMEoctinoxate, titanium dioxideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEEMULSIONThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE10/11/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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 NAMEBobbi Brown Professional Cosmetics Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEOCTINOXATE; TITANIUM DIOXIDEAn 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 NUMERATOR STRENGTH67; 17 
ACTIVE INGRED UNITmg/mL; mg/mL 

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This page was last updated on: 4/12/2024