Australian Gold

Product NDC
58443-0188
11-digit product format
584430188
Labeler code
58443
Product ID
58443-0188_9c58a9c0-5a41-3332-e053-2a95a90a26a1
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene and oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-10
Marketing end
0000-00-00
Substance
OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0188-35844301880359 mL in 1 BOTTLE (58443-0188-3) 59 ml2015-02-100000-00-00NoNoCurrent