spf 30 mineral Sunscreen

Product NDC
53634-128
11-digit product format
536340128
Labeler code
53634
Product ID
53634-128_401bac11-6cf0-56c9-e063-6294a90aed16
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Malin and Goetz Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3.71; 2.71 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
spf 30 mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE3.71 g/100mL
ZINC OXIDE2.71 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-128-01spf 30 mineral Sunscreen50 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-128SPF 30 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALIN AND GOETZ INC]2Current NDC, 1 package rows20241004_f3d39df9-1618-7014-e053-2995a90af7bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53634-128-015363401280150 mL in 1 TUBE (53634-128-01) 50 ml2022-12-15NoNoCurrent