SHADED

Product NDC
85319-201
11-digit product format
853190201
Labeler code
85319
Product ID
85319-201_459bde25-f541-9aa4-e063-6394a90a6cb1
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Potency No. 710 LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-14
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; 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
SHADED
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85319-201-85SHADED85 g in 1 BOTTLE, PUMPCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85319-201SHADED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [POTENCY NO. 710 LLC]1Current NDC, 1 package rows20250326_31177bbd-68b0-8b24-e063-6294a90aa8d8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85319-201-858531902018585 g in 1 BOTTLE, PUMP (85319-201-85) 85 g2020-08-14NoNoCurrent