Hurley
- Product NDC
- 58443-0400
- 11-digit product format
- 584430400
- Labeler code
- 58443
- Product ID
- 58443-0400_bf4eea4e-3b4a-4212-e053-2a95a90a8ccc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-01-30
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
- Active strength
- 29 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0400-4 | 58443040004 | 177 mL in 1 TUBE (58443-0400-4) | 177 ml | 2019-01-30 | 0000-00-00 | No | No | Current |