Mineral KidCreme SPF 50

Product NDC
49358-584
11-digit product format
493580584
Labeler code
49358
Product ID
49358-584_36dab0f1-afa7-a7f3-e063-6294a90aaee7
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 KidCreme SPF 50
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
49358-584-01Mineral KidCreme SPF 50100 mL in 1 TUBECREAM1002
49358-584-01Mineral KidCreme SPF 501 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-584MINERAL KIDCREME SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]1Current NDC, 2 package rows20230922_9ec56c68-6fea-444b-aeed-0b5d60c42e75.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49358-584-01493580584011 TUBE in 1 CARTON (49358-584-01) / 100 mL in 1 TUBE1 tube2023-07-01NoNoHistorical