Mineral Sunscreen SPF-30

Product NDC
83387-399
11-digit product format
833870399
Labeler code
83387
Product ID
83387-399_09769ae3-d1b1-e2dd-e063-6294a90a1f64
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
NEWCO LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-17
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 60 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mineral Sunscreen SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE60 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83387-399-00Mineral Sunscreen SPF-30177 mL in 1 BOTTLE, SPRAYLIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83387-399MINERAL SUNSCREEN SPF-30 (TITANIUM DIOXIDE, ZINC OXIDE) LIQUID [NEWCO LLC]2Current NDC, 1 package rows20231106_fa3c73a3-0dfb-4673-822a-45d946dee260.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83387-399-0083387039900177 mL in 1 BOTTLE, SPRAY (83387-399-00) 177 ml2023-04-17NoNoCurrent