FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85302-203
11-digit product format
853020203
Labeler code
85302
Product ID
85302-203_4577d278-1f96-e6cd-e063-6294a90a2537
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Face 5, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-17
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
85302-203-15Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85302-203-50Tinted Mineral Sunscreen50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85302-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FACE 5, LLC]1Current NDC, 1 package rows20250312_300268ff-f9ef-1006-e063-6294a90a5fdf.zip
85302-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FACE 5, LLC]1Current NDC, 1 package rows20250312_3001aa3a-cc8b-6ad4-e063-6394a90a223f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85302-203-15853020203151.5 g in 1 PACKET (85302-203-15) 1.5 g2022-11-23YesNoCurrent
85302-203-508530202035050 g in 1 BOTTLE, PUMP (85302-203-50) 50 g2024-04-17NoNoCurrent