Sundown Naturals
Saw Palmetto Extract 160 mg
Avoid-flaggedObjective label signals
Flagged excipients
1
1 avoid · 0 caution
FDA recalls
0
no recall history
CAERS reports
37
FDA consumer events
Certifications
0
none recorded
1 avoid-level excipient · Every flag below links to the authority's published citation.
Supplement Facts
4 active ingredients| Ingredient | Amount | % DV |
|---|---|---|
| Vitamin B6 UNII · KV2JZ1BI6Z | 5 mg | 250% |
| Zinc UNII · J41CSQ7QDS | 15 mg | 100% |
| Saw Palmetto extract Saw Palmetto | 160 mg | — |
| Xtra(R) Premium Blend Proprietary Blend (Combination) | 75 mg | — |
Flagged excipients
1 flagged · authority citations
- ● AVOIDTitanium Dioxide colorcolor
Banned in EU food products effective 2022-08 (Commission Regulation (EU) 2022/63) following EFSA Panel opinion that a safe daily intake could not be established due to genotoxicity concerns. Still GRAS in the US under 21 CFR 73.575 but EU position is stricter.
FDA CAERS · adverse event context
37
consumer-submitted adverse event reports filed with the FDA CFSAN Adverse Event Reporting System mentioning this product or its brand.
CAERS reports are unverified consumer submissions — not adjudicated causality. Large well-known brands accumulate proportionally more reports simply due to broader use. About CAERS →
Other ingredients
Gelatin · Vegetable Glycerin · Soy Lecithin · yellow Beeswax · natural Caramel color