85431-211 NDC - FOAM WEIGHTLESS SUNSCREEN NON-TINTED DRYTOUCH NT (TITANIUM DIOXIDE, ZINC OXIDE)

Drug Information

Product NDC: 85431-211
Proprietary Name: Foam Weightless Sunscreen Non-Tinted Drytouch NT
Non Proprietary Name: Titanium Dioxide, Zinc Oxide
Active Ingredient(s): 30 mg/g TITANIUM DIOXIDE; 100 mg/g ZINC OXIDE
Administration Route(s): TOPICAL
Dosage Form(s): AEROSOL, FOAM

Labeler Information

Field Name	Field Value
Labeler Name:	Cutis Wellness Dermatology And Dermatopathology PLLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M020
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	3/15/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	85431-211-04	113 g in 1 BOTTLE, PUMP (85431-211-04)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	85431-211	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	Foam Weightless Sunscreen Non-Tinted Drytouch NT	This is the date that the labeler indicates was the start of its marketing of the drug product.
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	AEROSOL, FOAM	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	TOPICAL	Name of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE	3/15/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	M020	The translation of the dosage form Code submitted by the firm.
LABELER NAME	Cutis Wellness Dermatology And Dermatopathology PLLC	This is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAME	TITANIUM DIOXIDE; ZINC OXIDE	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.
ACTIVE NUMERATOR STRENGTH	30; 100	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.
ACTIVE INGRED UNIT	mg/g; mg/g	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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