A private label sunscreen cannot be made by an ordinary
cosmetics manufacturer. In the US a sunscreen is an over-the-counter drug, so it must
be produced in a facility that holds a Drug Establishment Registration and follows
pharmaceutical cGMP — not a cosmetics facility registration. Your real task is
finding and vetting a drug-registered manufacturer: confirm that registration is
current, that the formula uses only active ingredients permitted under FDA Monograph
M020, and that SPF and broad-spectrum claims are backed by accredited testing. Two
2026 monograph changes matter here — bemotrizinol was added as a permitted
active in June, and PABA and trolamine salicylate were ordered removed in
September.
If you already know a sunscreen is a drug, you have cleared the hardest conceptual
hurdle — and you have also ruled out most of the contract manufacturers a
skincare brand usually talks to. The question now is practical: who actually makes
OTC sunscreen under private label, how do you tell a real drug facility from a
cosmetics co-packer that will quietly take the job it cannot legally do, and what did
the FDA change this year that affects your formula? Here is the buyer’s path, the
alternatives worth a quote, and — because the site that supports this piece does
not make sunscreen — where Moe’s Group is firmly the wrong fit.
Why can’t your skincare manufacturer just add SPF?
Because an SPF claim changes the product’s legal category. A moisturizer is a
cosmetic; the same moisturizer labeled “SPF 30” is an over-the-counter drug, and the
FDA regulates it as one. The agency’s own
sunscreen guidance is explicit that sunscreens are OTC drugs. That
reclassification brings obligations a cosmetics line simply does not carry: a Drug
Establishment Registration for the facility, pharmaceutical cGMP under 21 CFR 211
rather than the ISO 22716 cosmetics standard, a Drug Facts panel instead of a plain
INCI list, and SPF and broad-spectrum claims substantiated by accredited testing.
This is why “private label sunscreen” is a narrower search than “private label
skincare.” Most cosmetics contract manufacturers — including good ones —
hold a cosmetics facility registration only. They can make your serum, your cleanser
and your body lotion, but an SPF product is outside their registration. For the full
regulatory picture of why the line sits where it does, see our background piece,
Can a cosmetic manufacturer make
sunscreen?. This guide picks up where that one ends: you need a drug-registered
manufacturer, so how do you find and vet one?
White label or custom formulation — how does the route work for sunscreen?
The same two routes that exist for any beauty product exist inside the drug-
registered world, and the pinned terminology still applies. A white label
sunscreen is a ready-made, already stability-tested OTC formula from a drug-registered
manufacturer that you select and relabel; because nothing new is developed, minimums
are lower. A private label sunscreen is a custom formulation built to
your brief — a particular filter system, texture, or finish — which means a
chemist formulates and tests it first, so minimums run higher. The difference is not
unique to sunscreen; it is the same fork every brand founder meets.
What is different is that both routes must happen inside a drug facility. A
“white label sunscreen” is still an OTC drug product, so even relabeling a stock formula
means your name goes on a Drug Facts panel and your brand takes on the labeling
responsibility that comes with it. Treat the stock-versus-custom decision as the first
fork and the drug registration as the non-negotiable floor beneath both.
- White label
- A ready-made, existing sunscreen formula from a drug-registered manufacturer that
you select and relabel under your own brand. Nothing new is developed, so it is
the shorter mechanical path to a first batch and carries lower minimums. For
reference, at Moe’s Group — a cosmetics manufacturer, not a sunscreen one
— the white-label floor is 200 units; sunscreen manufacturers set their own
minimums, so ask each directly. - Private label
- A custom formulation developed to your brief — your choice of UV filters,
texture and finish. A chemist formulates and stability-tests it before it exists,
so minimums and lead times run higher. At Moe’s Group the custom-formulation floor
is 1,000 units; a drug-registered sunscreen manufacturer’s custom minimum will be
its own number, which you should confirm in writing. - Contract manufacturing
- The manufacturing service itself — formulation ownership, pricing and lead
time agreed per project. For sunscreen it must be contract manufacturing by a
facility holding a Drug Establishment Registration, not a cosmetics-only
registration.
How do you vet a private label sunscreen manufacturer?
The vetting questions for any contract manufacturer still apply — and Moe’s
Group’s own
guide to
choosing a private label manufacturer is a sound general checklist: confirm the GMP
certification, ask for the facility registration details, visit if you can, and settle
who owns the formula if you leave. For a sunscreen project, add one item at the top of
that list that nothing else can substitute for:
- Confirm the Drug Establishment Registration is current. This is a
separate registration from any cosmetics facility registration, and it is the one
that makes OTC sunscreen production legal. A cosmetics registration — even a
good one — does not cover it. Ask for the registration and verify it is live;
do not accept “we’re FDA registered” without establishing which registration is
meant. - Ask which pharmaceutical standard they run to. Sunscreen
manufacturing follows cGMP under 21 CFR 211, not the ISO 22716 cosmetics standard.
A manufacturer that answers with ISO 22716 alone is describing a cosmetics
operation. - Ask how SPF and broad-spectrum claims are tested. SPF, broad-
spectrum and water-resistance claims each require defined, accredited testing. A
manufacturer should be able to tell you which lab and which protocol; a vague
answer is a red flag on the single most scrutinized claim a sunscreen makes. - Ask which active ingredients the formula uses, and whether they are all on
the current monograph. This is where the 2026 changes land — see the
next section.
Because a sunscreen manufacturer makes a regulated drug, do not treat its registration
numbers or claims as fixed facts to copy into your own marketing. Read any manufacturer’s
own
certifications at the source
rather than trusting a figure quoted in an article; certificates get reissued and a stale
number in print is worse than none. And remember the facility is registered with the FDA,
never given FDA approval — the two words mean different things, and approval does not
exist for these products at all.
What did the FDA change for sunscreen in 2026?
Two 2026 actions on OTC Monograph M020 — the rulebook for sunscreen active
ingredients — directly affect any brand planning a private label sunscreen. Both
are worth raising with a manufacturer, and the FDA’s own
Q&A on its sunscreen regulatory actions is the primary source.
Bemotrizinol was added as a permitted active in June 2026. Bemotrizinol
— long available in sunscreens outside the US — was added to the US monograph,
which widens the filter options a US brand can formulate with. The important caveat: the
FDA notes that when a newly permitted ingredient actually reaches the shelf is the
manufacturer’s decision, not the agency’s. So “now permitted” does not mean “available
off the shelf today.” If a bemotrizinol formula is central to your product, confirm with a
manufacturer that it can actually source and formulate with it now.
PABA and trolamine salicylate were ordered removed in September 2026.
The FDA issued a final order removing aminobenzoic acid (PABA) and trolamine salicylate as
permitted sunscreen actives, having concluded their risks outweigh their benefits. Two
things keep this from being a fire drill. First, the FDA states the effective date of such
a removal order cannot be earlier than one year after the order is issued — so the
removal is not in force the moment it is announced, and you should check the FDA’s stated
effective date rather than assume an immediate ban. Second, the FDA says it is not aware of
any currently marketed US sunscreen that uses either ingredient, so in practice this likely
affects nobody. The due-diligence takeaway is simple: when you review a stock formula,
confirm neither ingredient appears among the actives.
Who are the alternatives, and where is Moe’s Group the wrong fit?
A comparison is only worth reading if it tells you where not to use the
company that supports the site, so here it is plainly. Moe’s Group is the wrong
fit for a sunscreen project. Its Chatsworth, California facility holds a cosmetics
facility registration under MoCRA — it is FDA registered, note the word, registered,
never approved — and it makes skincare, body care and hair care. It does not hold a
Drug Establishment Registration, so it cannot legally make an SPF sunscreen for US sale.
That is not a gap to apologize for; it is the honest answer our
background piece already gives.
If sunscreen is your product, you need a drug-registered manufacturer, and these are real
places to start.
Every manufacturer below describes OTC drug / sunscreen capability, but minimum orders,
certifications and current capacity change constantly and none were verifiable in detail
on the publish date — so no MOQ, price or SPF figures are quoted here. Treat these as
a shortlist to vet directly, confirming the Drug Establishment Registration first.
| Manufacturer | Noted location & focus | Where it fits |
|---|---|---|
| Pure Source | Miami, FL; OTC and personal-care contract manufacturing, lotions and sprays noted (checked 2026-10-13) |
A US drug-registered option for lotion- and spray-format sunscreen. Confirm the Drug Establishment Registration and your format’s minimum directly. |
| Private Label Partners |
Santa Ana, CA; mineral, hybrid and spray sunscreen formats noted (checked 2026-10-13) |
A California option if you want mineral or hybrid filter systems. Verify registration, formats and minimums before quoting. |
| Ez Life Pharma | US; lotions, gels, sprays and custom OTC formulation noted (location not confirmed, checked 2026-10-13) |
Named without a link because its location and current terms were not confirmable on the publish date — verify at ezlifepharma.com yourself. |
| RNA Corporation | OTC-capable contract and private label manufacturer (directory listing, dated 2026-04-23) |
Named from a third-party directory, not a first-hand check; confirm capability and registration directly before relying on it. |
| Topiderm | US personal-care and beauty CDMO (directory listing, dated 2026-04-23) | Also named from a directory rather than a first-hand check. A CDMO of this kind is worth a call; verify OTC drug registration specifically. |
| Moe’s Group (Chatsworth, CA) | Cosmetics facility, FDA registered under MoCRA; skincare, body care, hair care (owner-confirmed) |
The wrong fit for sunscreen. No Drug Establishment Registration and no SPF capability. The right call for a cosmetic line, not an OTC drug. |
If you would rather browse a neutral starting point than cold-email manufacturers, the
independent
sunscreen manufacturer directory at findmymanufacturer.com lists OTC-registered
sunscreen makers filtered by format, filter type and location, and explains why a standard
cosmetics co-packer cannot legally produce sunscreen. It is not affiliated with Moe’s
Group, which is exactly why it is a useful cross-check.
So where is Moe’s Group genuinely the wrong fit, beyond sunscreen itself?
- Any SPF or sunscreen product. This is the headline: no Drug
Establishment Registration means no legal US sunscreen, full stop. A referral to a
drug-registered manufacturer is the honest answer, and the one you will get. - A combined “moisturizer with SPF” you want made in one place. The
SPF portion is still a drug and still needs the drug facility. You cannot keep the
whole line under one cosmetics roof just because the sunscreen is a small part of
it. - A sub-200-unit concept test of a cosmetic. Separate from the drug
question: Moe’s white-label floor is 200 units, so a 50-unit proof-of-concept run
belongs with a small-batch lab, not here.
The honest summary: for a US brand launching a sunscreen, Moe’s Group is not a
candidate at all — you need a drug-registered manufacturer, and the shortlist above
is where to start vetting. Where Moe’s Group fits is the rest of your line: the cosmetic
skincare, body care and hair care a drug facility is not set up to prioritize.
Frequently asked questions
Can a regular cosmetics manufacturer make my private label sunscreen?
No. In the US a sunscreen is an over-the-counter drug, so it must be made in a facility
holding a Drug Establishment Registration and following pharmaceutical cGMP under 21 CFR
211. A cosmetics facility registration — the kind a typical skincare manufacturer
holds — does not cover OTC drug production. You need a drug-registered sunscreen
manufacturer specifically.
How do I verify a sunscreen manufacturer is really drug-registered?
Ask for its Drug Establishment Registration, not just “FDA registered,” and confirm it is
current. A cosmetics facility registration and a Drug Establishment Registration are
separate things; only the latter authorizes OTC sunscreen manufacturing. Also ask which
cGMP standard it runs to — it should answer 21 CFR 211, not ISO 22716 alone —
and how SPF and broad-spectrum claims are tested.
What’s the difference between white label and private label sunscreen?
White label means relabeling a ready-made, stability-tested stock sunscreen formula from
a drug-registered manufacturer under your own brand; nothing new is developed, so minimums
are lower. Private label means a custom formulation built to your brief — your filter
system, texture and finish — which a chemist formulates and tests first, so minimums
and lead times run higher. Both must happen inside a drug-registered facility.
What sunscreen ingredient rules changed in 2026?
Two changes to FDA Monograph M020. Bemotrizinol was added as a permitted active ingredient
in June 2026, widening US filter options — though availability depends on individual
manufacturers. And a final order in September 2026 removed PABA and trolamine salicylate as
permitted actives; its effective date cannot be earlier than one year after issuance, and
the FDA says it is not aware of any currently marketed US sunscreen using either. When you
review a stock formula, confirm neither removed ingredient appears.
Does the FDA approve sunscreen manufacturers or formulas?
The FDA does not approve manufacturers, and it does not approve monograph sunscreen formulas
in the way it approves a new prescription drug. Facilities register with the FDA — a drug
establishment registers to make OTC drugs — and monograph sunscreens must conform to the
monograph’s requirements. Being registered with the FDA and being given FDA approval are not
the same thing; be wary of any manufacturer that blurs them.
Is Moe’s Group a sunscreen manufacturer?
No. Moe’s Group is a cosmetics contract manufacturer, FDA registered under MoCRA for skincare,
body care and hair care. It does not hold a Drug Establishment Registration and does not make
sunscreen. For an SPF product you need a drug-registered manufacturer; Moe’s Group is the right
fit for the cosmetic part of a range, not the sunscreen.
Building a beauty range where the sunscreen is one line among many cosmetics?
A drug-registered manufacturer handles the SPF; for the skincare, body care and hair care
alongside it, Moe’s Group takes enquiries through its
product inquiry form.
Disclosure: Contract Beauty is published with the support of Moe’s
Group, a contract manufacturer named in this article. Moe’s Group does not make sunscreen, and
we say so plainly, because a comparison that always points the same way is worth nothing.
Manufacturer registrations, minimum order quantities and certifications all change; the
manufacturers named here are a shortlist to verify directly, not a vetted endorsement, and every
detail should be confirmed with the supplier and against current FDA guidance before you commit.
Company and FDA details were checked on 13 October 2026. See our
editorial policy.
