Australian Gold
- Product NDC
- 58443-0602
- 11-digit product format
- 584430602
- Labeler code
- 58443
- Product ID
- 58443-0602_f0495e32-5eb7-3336-e053-2995a90aa11f
- 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 NOT FINAL
- Marketing start
- 2019-10-14
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0602-4 | 58443060204 | 237 mL in 1 BOTTLE (58443-0602-4) | 237 ml | 2019-10-14 | 0000-00-00 | No | No | Current |