Home NDC 83447-009-01 Sky and Sol SPF25 Lip Balm
Product NDC 83447-009
Requested package NDC 83447-009-01
11-digit product format 834470009
Labeler code 83447
Product ID 83447-009_479ee2c0-168e-f6f6-e063-6294a90a5d22
Type HUMAN OTC DRUG
Nonproprietary name Sky and Sol SPF25 Lip Balm
Dosage form PASTE
Route TOPICAL
Labeler Guangzhou Fantesy Biotechnology Co.,Ltd
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-09
Substance ZINC OXIDE
Active strength 15 g/100g
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 Sky and Sol SPF25 Lip Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 15 g/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83447-009-01 Sky and Sol SPF25 Lip Balm 9 g in 1 BOX PASTE 9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83447-009 SKY AND SOL SPF25 LIP BALM PASTE [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD] 1 Current NDC, 1 package rows 20240811_1f37c0c3-6443-60a3-e063-6394a90a596f.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83447-009-01 83447000901 9 g in 1 BOX (83447-009-01) 9 g 2024-08-09 No No Current