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- Product NDC
- 58443-0518
- Requested package NDC
- 58443-0518-3
- 11-digit product format
- 584430518
- Labeler code
- 58443
- Product ID
- 58443-0518_d5c9d527-4d72-662f-e053-2a95a90af07c
- 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
- 2016-08-30
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE
- Active strength
- 25 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 |
|---|---|---|---|---|---|---|---|---|
| 58443-0518-3 | 58443051803 | 50 mL in 1 TUBE (58443-0518-3) | 50 ml | 2016-08-30 | 0000-00-00 | No | No | Current |