Mineral Creme SPF 50

Product NDC
49358-570
11-digit product format
493580570
Labeler code
49358
Product ID
49358-570_36d85f1d-3e7b-cf54-e063-6394a90af1ba
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 Creme SPF 50
Brand name suffix
Mineral Creme SPF 50 Broad Spectrum UVA-UVB 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
49358-570-01Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)50 mL in 1 TUBECREAM502
49358-570-01Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)1 in 1 CARTONCREAM12
49358-570-02Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)100 mL in 1 TUBECREAM1002
49358-570-02Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-570MINERAL CREME SPF 50 MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]1Current NDC, 4 package rows20230910_f8e178d6-058c-462a-8e59-6721f28ad040.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-570-01493580570011 TUBE in 1 CARTON (49358-570-01) / 50 mL in 1 TUBE1 tube2023-07-01NoNoHistorical
49358-570-02493580570021 TUBE in 1 CARTON (49358-570-02) / 100 mL in 1 TUBE1 tube2023-07-01NoNoHistorical