What does ANVISA require on cosmetic labels?
Brazil's RDC 375/2020 sets strict labeling requirements for all cosmetics sold in the country. ANVISA rejects 43% of imported cosmetics on labeling violations alone — making this one of the highest-impact compliance areas to get right.
Mandatory label elements (RDC 375/2020)
Every cosmetic label in Brazil must include these elements in Portuguese:
- Product name and brand — Must match the registered name
- Complete ingredient list — INCI names in descending order by concentration
- Net content — Metric units only (g, mL, L, kg)
- Country of origin — "Fabricado em [país]" or "Importado por [empresa]"
- Manufacturer or importer name and address
- ANVISA registration number — For Grade 2: "Registro Sanitário ANVISA nº XXX"
- Batch/lot number — Linked to manufacturing records
- Expiration date or PAO symbol — "Validade: DD/MM/AAAA" or Period After Opening icon
- Precautionary statements — Required for specific product categories
- Brazilian PTR name — Name of the Technical Responsible
Language requirements
100% Portuguese. No exceptions. Even "Made in USA" must be translated to "Fabricado nos EUA." Common mistakes:
- Leaving ingredient names in English or Latin (INCI is acceptable, but must be the official INCI name)
- Using "Net Wt." instead of "Conteúdo líquido" or "Conteúdo"
- Mixing Portuguese with English marketing claims
Ingredient list rules
- Descending order by concentration — Highest to lowest
- INCI nomenclature — Use official International Nomenclature
- Ingredients ≤1% can be in any order after the >1% ingredients
- Color additives — May be listed in any order, but must specify CI number
- Fragrance — Can be listed as "Parfum" or "Fragrance" plus specific allergens if required
Product-specific warning requirements
| Product Type | Required Warning |
|---|---|
| Hair dyes | "Contém ingredientes que podem causar reações alérgicas" |
| Products with AHAs/BHAs | "Use protetor solar durante e após o uso" |
| Children's cosmetics | "Uso sob supervisão de adulto" + age indication |
| Sunscreens | SPF value, UVA protection, reapplication instructions |
| External use only | "Uso externo. Não ingerir" |
Claims that trigger rejection
ANVISA strictly prohibits therapeutic claims on cosmetic labels. Avoid:
- "Trata" (treats), "Cura" (cures), "Elimina" (eliminates)
- "Anti-celulite" without clinical evidence
- "Clareia" (lightens) for non-registered whitening products
- "Dermatologicamente testado" without supporting data
Label verification checklist
Before printing your Brazilian labels:
- [ ] All text in Portuguese
- [ ] Metric units only
- [ ] Complete INCI ingredient list
- [ ] ANVISA registration number (Grade 2)
- [ ] PTR name included
- [ ] Batch number and expiration date
- [ ] Required warnings for product category
- [ ] No therapeutic claims