ALOE UP

Product NDC
58443-0417
11-digit product format
584430417
Labeler code
58443
Product ID
58443-0417_cb96bbbd-bd31-4c59-e053-2a95a90a606a
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Avobenzone, Homosalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-03-10
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength
101 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0417-35844304170389 mL in 1 BOTTLE (58443-0417-3) 89 ml2020-03-100000-00-00NoNoCurrent