SPF 40 Broad Spectrum Non-Tinted

Product NDC
85339-205
11-digit product format
853390205
Labeler code
85339
Product ID
85339-205_45b39b5c-66a1-e07b-e063-6294a90a3339
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Teton Dermatology Holdings, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-27
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPF 40 Broad Spectrum Non-Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85339-205-04SPF 40 Broad Spectrum Non-Tinted113 g in 1 BOTTLE, PUMPCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85339-205SPF 40 BROAD SPECTRUM NON-TINTED (ZINC OXIDE) CREAM [TETON DERMATOLOGY HOLDINGS, INC.]1Current NDC, 1 package rows20250515_35093797-008b-b265-e063-6294a90a9949.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85339-205-0485339020504113 g in 1 BOTTLE, PUMP (85339-205-04) 113 g2023-10-27NoNoHistorical