Personal Care Manufacturing

Formulation, stability, filling, componentry, and compliance are five different vendors for most brands. MakeMine runs them as one process — so the chemist, the filler, the component supplier, and the regulatory requirement are on the same schedule.

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In personal care, the vendors don't talk to each other

A brand starts with a lab. The lab develops a formula. The formula goes to a filler who has never seen it and immediately asks for changes because their equipment can't run it at that viscosity. The component supplier quotes a jar that the formula turns out to be incompatible with. Stability testing starts three months later than it should have, because nobody owned the calendar.

None of these vendors did anything wrong. Each solved its own problem. What failed is the space between them — and the brand, which has never done this before, is the only party standing in that space.

That gap is what MakeMine closes. One team holds the formula, the fill, the component, and the regulation against one schedule.

What MakeMine manages

Formulation

Custom development or a stock base modified to your spec, with a target cost and a manufacturable viscosity from the start. → Formulation

Sampling and stability

Bench samples, accelerated and real-time stability, preservative efficacy, and packaging compatibility. → Sampling

Ingredient sourcing

Actives, base materials, and fragrance sourced with COAs, use-level limits, and lead times understood. → Ingredients

Componentry and packaging

Primary containers, closures, decoration, secondary packaging, and the tooling timeline behind them. → Packaging

Manufacturing

Batching, filling, capping, labeling, and pack-out at the facility matched to your batch size. → Production

Quality and compliance

GMP manufacturing, labeling review, micro testing, and the data behind your safety substantiation. → Quality

Private label

A faster route for brands that don't need a proprietary formula. → Private Label

How a personal care program runs

Typical duration
  1. Brief

    1–2 weeks

    Target product, claims, price point, volume, and timeline defined

  2. Formulation

    8–16 weeks

    Bench development to a manufacturable, cost-viable formula

  3. Component selection

    Runs parallel to formulation

    Primary and secondary packaging specified and quoted

  4. Stability & compatibility

    12 weeks minimum

    Accelerated stability, PET, and product-in-package testing

  5. Regulatory

    Runs parallel

    Labeling built, safety substantiation assembled, FDA registration and listing

  6. Pilot batch

    3–5 weeks

    Scale-up trial confirming the formula runs on production equipment

  7. Production

    6–12 weeks

    Batching, filling, decoration, pack-out

Phase 4 is a floor, not an estimate. Accelerated stability takes twelve weeks of calendar time and cannot be compressed by paying more.

Private label vs. custom formulation

These are two different businesses with different timelines, minimums, and defensibility. Most founders arrive asking for one and need the other.

Private label / stock baseCustom formulation
What you getAn existing formula, your branding, sometimes a modified fragrance or colorA formula developed to your specification
Formula ownershipThe manufacturer's — usually sold to others tooYours, defined in the manufacturing agreement
Typical MOQ500–2,500 units per SKU2,500–10,000 units per SKU
Time to first production8–16 weeks9–15 months
Development costLow to noneSignificant — bench, testing, and pilot batch
Claims you can makeLimited to what the base supportsBuilt around the claim you want to make
Best forTesting a market, extending a line, fast launchA brand whose product is the differentiator

Cosmetic or OTC drug — which is your product?

In the US, intended use determines classification, and classification determines everything downstream. This is the most consequential question in the category and most founders don't know they're asking it.

ProductClassificationWhat that requires
Moisturizer, serum, cleanserCosmeticMoCRA registration and listing, safety substantiation, cosmetic labeling
SunscreenOTC drugMonograph compliance, Drug Facts panel, NDC, 21 CFR 210/211 cGMP
Acne treatment (salicylic acid, benzoyl peroxide)OTC drugSame as above
AntiperspirantOTC drugSame as above
Deodorant (no antiperspirant claim)CosmeticCosmetic pathway
Anti-dandruff shampooOTC drugSame as above
Standard shampoo, conditionerCosmeticCosmetic pathway
Lip balm with SPFOTC drugSame as above
Lip balm without SPFCosmeticCosmetic pathway

An OTC drug product cannot be made at a cosmetics-only facility. Choosing the wrong facility is a restart, not a correction.

What MakeMine will tell you

  • If your volume doesn't support custom formulation, we say so and show you what private label gets you instead.
  • If your claim requires a clinical study you haven't budgeted for, you hear it before formulation starts.
  • If your product is an OTC drug and you thought it was a cosmetic, we tell you in the first conversation. It changes the facility, the cost, and the timeline.
  • Stability takes twelve weeks. We don't quote around it.

Frequently asked questions

What does a personal care contract manufacturer do?

A contract manufacturer formulates, batches, fills, and packages personal care products under your brand. Some offer only filling; others include formulation, stability testing, componentry, and regulatory support. The scope varies enough between facilities that "contract manufacturer" describes a range rather than a defined service.

How long does it take to launch a personal care product?

Private label from a stock base typically runs 8 to 16 weeks to first production. Custom formulation runs 9 to 15 months, because formulation, twelve weeks of stability testing, component tooling, and a pilot batch all have to complete before production can start.

What is the minimum order for personal care manufacturing?

Private label typically starts at 500 to 2,500 units per SKU. Custom formulation typically starts at 2,500 to 10,000 units. Minimums are usually set by the batch size the filling equipment requires and the component supplier's minimum, not by the manufacturer's preference.

Is my product a cosmetic or an OTC drug?

Intended use decides it. Products that only cleanse, moisturize, or beautify are cosmetics. Products that make a therapeutic claim — sun protection, acne treatment, antiperspirant, anti-dandruff — are OTC drugs, requiring monograph compliance, a Drug Facts panel, an NDC number, and manufacturing under 21 CFR 210/211. The same lip balm is a cosmetic without SPF and a drug with it.

Do I need FDA approval to sell a cosmetic?

No. Cosmetics do not require pre-market FDA approval. They do require compliance with MoCRA, which mandates facility registration, product listing, a named Responsible Person, adequate safety substantiation, and adverse event reporting. Approval and compliance are different obligations, and only one of them is optional.

Can MakeMine work with my existing formula?

Yes. An existing formula can be transferred to a new manufacturer, though it requires a technical review, a scale-up trial, and usually new stability testing in the new facility's process. Formulas rarely transfer without adjustment because equipment differs between facilities.

One team from formula to filled unit.

Formulation, testing, componentry, and compliance on one schedule. Book a call to walk through your product.