Private label sunscreen manufacturers and white label SPF

Why a sunscreen launch is a drug launch

In the US a sunscreen is an over-the-counter drug, not a cosmetic. The rules sit in OTC Monograph M020, which came into force by operation of law on March 27, 2020 under the CARES Act. A product that follows the monograph does not need FDA approval before it goes on sale, but it has to be made, listed and labeled like a drug, and that changes who can make it for you.

Under 21 CFR 207.17 every establishment that manufactures, repacks or relabels a drug has to register with FDA. A skincare lab that only makes cosmetics can be excellent at serums and still be unable to fill your SPF moisturizer. That is why most private label skin care manufacturers never mention sunscreen, and why the real shortlist is much shorter than it looks. Every maker in the table below states FDA registration on its own site (for a verdict on each, see our roundup of the best private label sunscreen manufacturers); Pure Source says "FDA-registered, cGMP-compliant facility located in the United States", Respect Manufacturing in Denver says "FDA-registered facility" and "CGMP Certified".

Your brand, if it owns no factory, does not have to register an establishment. It still has paperwork of its own, covered further down. We do not file regulatory submissions or classify products, so treat this page as a buyer's map and confirm the details with the maker and your own regulatory adviser.

The minimum is high, and only two makers print it

Of the 12 makers we read, two publish a hard minimum. Pure Source in Miami: "a minimum of 5,000 units per product", and "We cannot manufacture orders under 5,000 units." Solésence, the mineral specialist outside Chicago, prints "MOQ: 10,000" for its white label and white label+ paths and "30,000" for custom development, without saying what the unit is. Ask whether that is filled units, and at what size, before you plan cash around it.

Pure Velocity says "stock sunscreen launches typically start at 5,000 to 10,000 units", which is a typical range, not a policy. Respect Manufacturing and InSpec Solutions both write that minimums vary by format and packaging. Private Label Partners in Santa Ana offers "pilot batches to large-volume runs" with no number. Formulated Solutions, which fills lotions, tubes and bag-on-valve cans in Largo, Florida and Cleveland, Tennessee, publishes batch sizes instead: "25 to 4,000-gallon scale".

Gallons are not a useless number. As a worked model, 25 gallons is 3,200 fluid ounces, which fills about 1,066 three-ounce tubes before any fill loss. Assume a different size and the count moves with it, so treat this only as a way to compare a batch quote with a unit quote. Compared with lip balm, where we found stock runs in the hundreds (see private label lip balm manufacturers), SPF starts an order of magnitude higher. A first run of 5,000 units is the realistic floor for a branded US sunscreen.

The test bill is the real gate, and a pre-tested formula skips it

The number that decides a custom launch is not on the purchase order. It is the cost of proving the label. Under 21 CFR 201.327 the SPF value comes from an in vivo test on a panel large enough to give at least 10 valid results. A "broad spectrum" claim needs a mean critical wavelength of 370 nm or more. "Water resistant (40 minutes)" or "(80 minutes)" each need their own test. Solésence is the only maker that prints a price: its "standard regulatory package, which includes SPF testing, starts at $16,000" and takes 12 to 20 weeks, covering static SPF, broad spectrum, water resistance, HRIPT and phototoxicity.

We also looked for a published price from the US labs that run these tests, including Eurofins, SGS, BioScreen, AMA Labs, Princeton Consumer Research and Ivy Labs. None publishes one. Plan on a quote, and ask the maker who books the lab and who pays.

The way around the bill is a formula that already has its data. InSpec Solutions writes that "most new brands start from our library of SPF formulas, already tested for their SPF and broad-spectrum claims". Solésence says its white label products "have completed SPF testing" and that it covers testing on the white label paths. On a custom formula the brand pays and Solésence runs the logistics. So the first decision in your brief is stock or custom. A stock formula with your label can reach the shelf without the $16,000 and the extra months; a custom formula buys you a unique product at that price. Before you ask for changes to a tested formula, ask the maker whether the change reopens testing.

Your NDC and labeler code are yours to get

Every sunscreen carries a National Drug Code on its Drug Facts label. The rules for private label are specific. Under 21 CFR 207.33(c)(1), each person who engages in private label distribution "must apply for an NDC labeler code". Under 207.41(c), the manufacturer lists your drug with FDA using an NDC that includes your labeler code, and lists it under its own code as well. In plain terms, the factory files the listing, and the first segment of the NDC on your carton identifies your brand.

None of the 12 makers we read publishes how it handles this. Pure Velocity notes that the product needs "a drug listing with a National Drug Code" but not who files it. Put three lines in the brief: will you file our listing, do we need our labeler code before the run, and whose name goes in the "Distributed by" line. A maker that answers all three quickly has done private label OTC work before.

The facility fee that never shows on the quote

OTC monograph drugs carry an annual FDA user fee, OMUFA, charged per facility. FDA set the fiscal 2026 rates (October 1, 2025 to September 30, 2026) at $19,188 for a monograph drug facility and $12,792 for a contract manufacturing facility, down from $37,556 and $25,037 in fiscal 2025. FDA's OMUFA page lists fiscal 2027 at $47,891 and $31,927. The fee is assessed on whoever owns the facility. As we read the rules, a brand with no facility of its own does not pay it, but the maker builds it into what it charges.

That is why OTC sunscreen work clusters in fewer, larger plants, and why a small cosmetic filler rarely adds SPF to its menu for one client. For the same reason, a maker's willingness to take a 5,000 unit run says more about its order book than its prices do. If you also need other OTC products, such as acne treatments or antiperspirants, the pharmaceutical contract manufacturers guide covers the wider drug side.

Format and filter decide the shortlist

Format narrows the list faster than anything else. For bag-on-valve and continuous sprays: Pure Source fills "BOV sprays, Continuous spray, manual sprays", InSpec runs "continuous spray on our own bag-on-valve line", Prime Matter Labs cites more than 12 million units of bag-on-valve capacity at its Medley, Florida plant, and Formulated Solutions fills BOV and aerosols. For sticks: InSpec makes "hot-fill mineral and tinted sticks", and Private Label Partners offers "sticks in multiple sizes". For mineral only: Solésence makes its own mineral actives in its Chicagoland facility.

The filter list itself is moving. FDA's final order of June 10, 2026 added bemotrizinol to the sunscreen monograph, the first new filter in decades, and Bell International Laboratories in Eagan, Minnesota already offers it in "Bag-on-Valve, Finger Pump Sprays and Flairosol sprays". On September 10, 2026 FDA issued a final order removing PABA and trolamine salicylate. The rest of FDA's 2021 proposal, including a proposed labeled SPF cap of 60+ and the dosage form rules, is still a proposal, so today 201.327 sets no SPF cap. Some labels are off limits now, though: "sunblock", "sweatproof" and "waterproof" are false or misleading under 201.327, and using them makes the product misbranded.

Lead time, and what starts the clock

Published timelines are short for a stock formula and long for a custom one. Pure Source: "8 to 12 weeks depending on formulation complexity, testing requirements, and packaging details", without saying what starts the clock. Pure Velocity: "90 to 120 days" from "signed agreement" to finished inventory. Respect Manufacturing: development "4-8 weeks, with production runs scheduled based on your launch timeline". Solésence: 6 to 9 months for white label, 6 to 12 for white label+, 9 to 18 for custom.

Read those against the testing window. A custom formula that needs the 12 to 20 week test package cannot ship in 12 weeks, whatever the production slot says. If you want stock on shelves for a US summer selling season, a custom formula means starting the year before. A tested stock formula is the only realistic route to a launch this season. Ask every maker the same question: does your quoted lead time start at the signed order, the approved formula, the finished test report or the day packaging arrives?

What to send a sunscreen maker

A brief that gets a real quote fits on one page. Include the format (lotion, cream, stick, BOV spray, continuous spray, tinted), the filter type (mineral, chemical or hybrid), the SPF and water resistance claims you want, the fill size and packaging (or ask for theirs), and stock or custom formula. Give two quantities, for example 5,000 and 10,000 units, so the one-time costs separate from the unit price. Then ask the drug questions: who files the listing, whether you need a labeler code first, who books and pays for SPF testing, and what starts the lead time.

That is the request Suppliers sends for you. Describe the product once and the AI sourcing agent shortlists FDA-registered sunscreen makers that fill your format at your quantity, verifies each company's identity and registrations with the evidence shown, and lines up the answers side by side. If your first quantity is under the 5,000 unit floor, the low MOQ manufacturers guide covers the categories where small runs are realistic. AI does the shortlist and the comparison; you choose the maker.