SPF 50 Mineral Based Facial Sunscreen

Product NDC
81679-258
11-digit product format
816790258
Labeler code
81679
Product ID
81679-258_d1612c94-e50e-4ba5-a591-a7dfa77fb5f8
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Hutton, Kathleen MD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-25
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
SPF 50 Mineral Based Facial 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
81679-258-50SPF 50 Mineral Based Facial Sunscreen53 g in 1 BOTTLE, PUMPCREAM531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81679-258SPF 50 MINERAL BASED FACIAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD]1Current NDC, 1 package rows20240329_5cf0d2e3-d496-424c-ac75-70ff5b87e9ca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81679-258-508167902585053 g in 1 BOTTLE, PUMP (81679-258-50) 53 g2024-03-25NoNoCurrent