59958-200 NDC - ANHYDROUS SPF 30 ()

Drug Information

Product NDC: 59958-200
Proprietary Name: Anhydrous SPF 30
Non Proprietary Name:
Active Ingredient(s): 10.2 g/100g TITANIUM DIOXIDE; 3.7 g/100g ZINC OXIDE10.2 g/100g TITANIUM DIOXIDE; 3.7 g/100g ZINC OXIDE
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	Owen Biosciences, Inc.
Product Type:
FDA Application Number:	part352
Marketing Category:	OTC MONOGRAPH FINAL
Start Marketing Date:	9/1/2009

Package Information

No.	Package Code	Package Description	Billing Unit
1	59958-200-01	100000 g in 1 DRUM (59958-200-01)
2	59958-200-02	30 g in 1 TUBE (59958-200-02)
3	59958-200-03	30 g in 1 TUBE (59958-200-03)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	59958-200	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.
PROPRIETARY NAME	Anhydrous SPF 30	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	9/1/2009	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	part352	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.
LABELER NAME	Owen Biosciences, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	59958-200	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.
PROPRIETARY NAME	Anhydrous SPF 30	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	3/1/2011	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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	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.
LABELER NAME	Owen Biosciences, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	59958-200	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.
PROPRIETARY NAME	Anhydrous SPF 30	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	3/1/2011	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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	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.
LABELER NAME	Owen Biosciences, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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