tinted mineral sunscreen

Product NDC
85425-203
11-digit product format
854250203
Labeler code
85425
Product ID
85425-203_459b1f3a-7733-da84-e063-6294a90ad9c5
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Skin & Bare It LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-30
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
tinted mineral sunscreen
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
85425-203-50tinted mineral sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85425-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SKIN & BARE IT LLC]1Current NDC, 1 package rows20250529_35d42661-e511-1dfc-e063-6294a90a9ed7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85425-203-508542502035053 g in 1 BOTTLE, PUMP (85425-203-50) 53 g2019-05-30NoNoHistorical