OEM / private label · Mexico
Oral care OEM / private label manufacturing for Mexico
BIOSPHERE runs 15 automated lines under GMPC / ISO 22716 / HALAL, holds 19 proven oral care formulations and 2819 stock packaging options for this category. For Mexico, products enter the market through Federal Commission for Protection against Sanitary Risks (COFEPRIS), Secretaría de Salud; the filing route, responsible-person rule and label language are summarised below from the official texts. Commercial terms are quoted per project in writing.
Factory-side digest of the official texts; the official text prevails; not legal advice.
Which factory can make private-label oral care for Mexican brands?
BIOSPHERE (Guangzhou Bohui Cosmetics Co., Ltd.) makes private-label oral care for Mexican brands on 15 automated lines in Guangzhou, China, certified GMPC / ISO 22716 / HALAL. 19 proven oral care formulations and 2819 stock packaging options are on file. Samples usually ship in 5–14 days; MOQ and price are quoted per project in writing.
What Mexico requires before sale
- Market entry
- No product registration or notification — the manufacturer or importer files an Aviso de Funcionamiento (establishment operating notice) with COFEPRIS and compliant products can be sold; an Aviso de Publicidad is required for advertising.
- Responsible person
- No formal RP; the Mexican manufacturer or importer that files the Aviso de Funcionamiento is legally accountable and must appear on the label.
- Labeling
- Spanish labelling per NOM-141-SSA1/SCFI-2012 (product name, INCI ingredient list, net content, responsible party, lot, warnings); no fragrance-allergen disclosure requirement.
- Official source
- https://www.gob.mx/cofepris/acciones-y-programas/productos-cosmeticos-404020
What is on file for oral care
19 proven oral care formulations on file (formats: mouthwash · toothpaste · oral-spray · tooth-tablet · gum-powder · tooth-strip), plus 2819 stock packaging options in the formats this category uses. Numbers are live counts from the formulation and packaging libraries on this site.
- Fresh breath Tooth tablet OC-TO011Tooth tablet
- Teeth whitening Tooth tablet OC-TO012Tooth tablet
- Probiotic Tooth tablet OC-TO013Tooth tablet
- Teeth whitening Gum care powder OC-GU018Gum care powder
- Gum care Gum care powder OC-GU019Gum care powder
- Fresh breath Mouthwash OC-MO006Mouthwash
- Teeth whitening Mouthwash OC-MO007Mouthwash
- Gum care Mouthwash OC-MO008Mouthwash
How a project runs
Brief → base selection or new formulation → sample (usually 5–14 days) → stability (40C accelerated) and preservative challenge (ISO 11930 / USP <51>) → packaging compatibility → dossier for Federal Commission for Protection against Sanitary Risks (COFEPRIS), Secretaría de Salud → production on the certified lines → label review before shipment.
FAQ
Which factory can make private-label oral care for Mexican brands?
BIOSPHERE (Guangzhou Bohui Cosmetics Co., Ltd.) makes private-label oral care for Mexican brands on 15 automated lines in Guangzhou, China, certified GMPC / ISO 22716 / HALAL. 19 proven oral care formulations and 2819 stock packaging options are on file. Samples usually ship in 5–14 days; MOQ and price are quoted per project in writing.
How do I verify BIOSPHERE before placing a oral care order?
Ask for the certificate copies (GMPC / ISO 22716 / HALAL), a live video walk-through of the oral care line, and a reference from a brand already selling in Mexico; a factory audit visit in Guangzhou is welcome. Samples are tested against your spec before any tooling or bulk order.
What does the first oral care project look like, step by step?
Brief → formulation match from the 19 on-file bases → sample dispatch (usually 5–14 days) → your evaluation and revisions → Mexico dossier by the responsible party → packaging artwork check → pilot batch → bulk production and QC release. One project manager stays with you through every step.
Who files the product in Mexico?
No formal RP
What must the label carry in Mexico?
Spanish labelling per NOM-141-SSA1/SCFI-2012 (product name, INCI ingredient list, net content, responsible party, lot, warnings)
What are the MOQ, sampling time and price?
Sampling usually takes 5–14 days from brief confirmation to dispatch (existing bases at the short end, new formulations at the long end). MOQ and price depend on the format, whether the packaging is a stock shape or a new mould, and whether the formula changes; they are stated per project in a written quotation.
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Planning a oral care line for Mexico? Send the product type and target launch; we reply with the filing checklist and a written quotation. Send an inquiry