Mineral Tinted SPF 30

Product NDC
49358-571
11-digit product format
493580571
Labeler code
49358
Product ID
49358-571_36d86ec1-c63c-d417-e063-6394a90a5f9f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MDSolarSciences
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
20; 170 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mineral Tinted SPF 30
Brand name suffix
Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE20 mg/mL
ZINC OXIDE170 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-571-01Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)1 in 1 CARTONCREAM12
49358-571-01Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-571MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]1Current NDC, 2 package rows20230910_adcd6881-fa25-4312-95e5-5b47102aa6b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-571-01493580571011 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE1 tube2023-07-01NoNoHistorical