Tinted Mineral Sunscreen

Product NDC
85645-258
11-digit product format
856450258
Labeler code
85645
Product ID
85645-258_45b40fc7-3e8b-cacf-e063-6294a90a8251
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
LEILANI VIDAL
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-05
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100; 30 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 DIOXIDE100 mg/g
ZINC OXIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85645-258-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85645-258-508564502585053 g in 1 BOTTLE, PUMP (85645-258-50) 53 g2024-06-05NoNoHistorical