Home NDC 84446-505 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength ZINC OXIDE 140 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84446-505-00 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 89 mL in 1 TUBE LOTION 89 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84446-505 SABAL MINERAL SUNSCREEN BROAD SPRECTRUM SPF 30 (ZINC OXIDE) LOTION [SABAL SUN LLC] 1 Current NDC, 1 package rows 20240627_f917b446-4e10-4231-826e-fdac32e11186.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84446-505-00 84446050500 89 mL in 1 TUBE (84446-505-00) 89 ml 2024-06-11 No No Current