Tinted Mineral Sun Protectant

Product NDC
85459-203
11-digit product format
854590203
Labeler code
85459
Product ID
85459-203_4602711c-3c90-1801-e063-6394a90a08d4
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
PANDA PAMPERING LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-15
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 Sun Protectant
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
85459-203-15Tinted Mineral Sun Protectant1.5 g in 1 PACKETCREAM1.52
85459-203-50Tinted Mineral Sun Protectant53 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85459-203-15854590203151.5 g in 1 PACKET (85459-203-15) 1.5 g2020-10-15YesNoCurrent
85459-203-508545902035053 g in 1 BOTTLE, PUMP (85459-203-50) 53 g2020-10-15NoNoCurrent