Home NDC 58443-0294 Black Girl Sunscreen
Product NDC 58443-0294
11-digit product format 584430294
Labeler code 58443
Product ID 58443-0294_9d4e18ab-27e6-7e36-e053-2a95a90a5747
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-04-29
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 29 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 58443-0294 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0294 58443-0294-3 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0294-3 58443029403 89 mL in 1 TUBE (58443-0294-3) 89 ml 2019-04-29 0000-00-00 No No Current