FDA — FD&C Act + MoCRA
FDA 21 CFR 700 + OTC monographs + CIR safety assessments
15 compiled entries · 6 banned · 9 restricted
| Ingredient | Status | Limit | Rule | Citation |
|---|---|---|---|---|
| mercury | Banned | — | 21 CFR 700.13 — prohibited except trace in eye-area antiseptics | Source |
| chloroform | Banned | — | 21 CFR 700.18 — prohibited ingredient | Source |
| vinyl chloride | Banned | — | 21 CFR 700.14 — prohibited in aerosols | Source |
| zirconium | Banned | — | 21 CFR 700.16 — prohibited in aerosols (complexes) | Source |
| bithionol | Banned | — | 21 CFR 700.11 — prohibited ingredient | Source |
| chlorofluorocarbon | Banned | — | 21 CFR 700.23 — prohibited propellant | Source |
| hexachlorophene | Restricted | ≤ 0.1% | 21 CFR 250.250 — Rx only except ≤0.1% OTC (preservative exception) | Source |
| phenoxyethanol | Restricted | ≤ 1% | CIR 2011: safe ≤1.0%; FDA advisory flag for infant products | Source |
| salicylic acid | Restricted | ≤ 2% | FDA OTC acne/anti-dandruff monograph ≤2% leave-on; ≤3% rinse-off (salicylate) | Source |
| zinc pyrithione | Restricted | ≤ 1% | FDA OTC anti-dandruff monograph ≤1.0% | Source |
| resorcinol | Restricted | ≤ 3% | FDA OTC anti-dandruff monograph ≤3% | Source |
| selenium sulfide | Restricted | ≤ 1% | FDA OTC anti-dandruff ≤1.0% | Source |
| coal tar | Restricted | ≤ 5% | FDA OTC anti-dandruff ≤5% (coal tar solution equivalent) | Source |
| oxybenzone | Restricted | ≤ 6% | FDA sunscreen proposed rule — pending final rulemaking; CIR recommends ≤6% | Source |
| homosalate | Restricted | ≤ 15% | FDA proposed sunscreen ≤15% (proposed order 2019) | Source |
2026-07-21 · Compiled from cited primary sources. Informational only — not legal advice.
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