SABAL Mineral Sunscreen Broad Sprectrum SPF 30

Product NDC
84446-505
11-digit product format
844460505
Labeler code
84446
Product ID
84446-505_48c0c219-ee04-df0a-e063-6394a90a89f7
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SABAL SUN LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-11
Substance
ZINC OXIDE
Active strength
140 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SABAL Mineral Sunscreen Broad Sprectrum SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE140 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84446-505-00SABAL Mineral Sunscreen Broad Sprectrum SPF 3089 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84446-505SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30 (ZINC OXIDE) LOTION [SABAL SUN LLC]1Current NDC, 1 package rows20240627_f917b446-4e10-4231-826e-fdac32e11186.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84446-505-008444605050089 mL in 1 TUBE (84446-505-00) 89 ml2024-06-11NoNoHistorical