OEM / private label · the United States
Oral care OEM / private label manufacturing for the United States
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 the United States, products enter the market through U.S. Food and Drug Administration (FDA); 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 US brands?
BIOSPHERE (Guangzhou Bohui Cosmetics Co., Ltd.) makes private-label oral care for US 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 the United States requires before sale
- Market entry
- No pre-market approval — MoCRA requires facility registration (renewed every two years) and product listing (updated annually) through FDA's Cosmetics Direct portal, enforced since 2024-07-01; color additives need FDA approval and sunscreens/anti-dandruff products are OTC drugs.
- Responsible person
- A 'responsible person' is the manufacturer, packer or distributor whose name appears on the label; a U.S. address is not mandated, but foreign facilities must name a U.S. agent and the responsible person must handle adverse-event reporting.
- Labeling
- English labelling per 21 CFR 701 and the FPLA (identity, net contents, ingredients in descending order, warnings, responsible person name/address); MoCRA adds a domestic address/phone or e-mail for adverse-event contact and professional-use statements; fragrance-allergen disclosure starts only once FDA's pending rule is final.
- Official source
- https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
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 U.S. Food and Drug Administration (FDA) → production on the certified lines → label review before shipment.
FAQ
Which factory can make private-label oral care for US brands?
BIOSPHERE (Guangzhou Bohui Cosmetics Co., Ltd.) makes private-label oral care for US 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 the United States; 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 → the United States 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 the United States?
A 'responsible person' is the manufacturer, packer or distributor whose name appears on the label
What must the label carry in the United States?
English labelling per 21 CFR 701 and the FPLA (identity, net contents, ingredients in descending order, warnings, responsible person name/address)
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 the United States? Send the product type and target launch; we reply with the filing checklist and a written quotation. Send an inquiry