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- Product NDC
- 58443-0416
- 11-digit product format
- 584430416
- Labeler code
- 58443
- Product ID
- 58443-0416_cb7d7894-aafd-382d-e053-2a95a90a716c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octisalate, Avobenzone, Homosalate, Octocrylene
- Dosage form
- SPRAY
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0416-3 | 58443041603 | 89 mL in 1 BOTTLE (58443-0416-3) | 89 ml | 2020-03-10 | 0000-00-00 | No | No | Current |