No — a cosmetic manufacturer generally cannot legally make sunscreen for US commercial sale. In the United States, sunscreens are over-the-counter (OTC) drugs, so any product carrying an SPF claim must be made in a facility that holds a Drug Establishment Registration and follows pharmaceutical cGMP under 21 CFR 211. A cosmetic facility’s FDA registration — the kind Moe’s Group holds under MoCRA — covers cosmetics only and does not authorize OTC drug manufacturing. If you want to add SPF to your line, you need a different, drug-registered manufacturer.
This trips up more founders than almost any other line-extension question. You have a skincare manufacturer you trust, your serums and moisturizers ship on time, and adding “SPF 30” to the range looks like a small next step. Legally, it is not a small step — it moves the product into a different regulatory category with a different factory behind it. Here is why, where the line actually sits, and which manufacturers do make sunscreen.

Why is sunscreen a drug and not a cosmetic?
In the US, a sunscreen is classified as an over-the-counter drug, not a cosmetic. The FDA states this plainly: because sunscreens make a claim to affect the structure or function of the body — protecting skin from UV — they are regulated as drugs (FDA: Sunscreen — How to Help Protect Your Skin).
That classification is not cosmetic paperwork with an extra form. It changes the manufacturer’s obligations:
- The facility must hold a Drug Establishment Registration, separate from any cosmetic facility registration.
- Manufacturing must comply with pharmaceutical current good manufacturing practice under 21 CFR 211, not the cosmetics GMP of ISO 22716.
- SPF claims must be substantiated by FDA-recognized SPF testing at accredited labs. Broad-spectrum claims require critical-wavelength testing to at least 370 nm; water-resistance claims require a defined 40- or 80-minute protocol.
- The finished product carries a Drug Facts panel, not just an INCI ingredient list.
- Active ingredients are limited to those in the OTC monograph, used within monograph concentrations — the mineral filters zinc oxide and titanium dioxide, and chemical filters such as avobenzone and octocrylene.
The current rulebook is OTC Monograph M020 — Sunscreen Drug Products for OTC Human Use, which took effect on 9 August 2026. If a manufacturer is not set up for OTC drug production, none of the above is a bolt-on; it is a different operation.

What does a cosmetic manufacturer’s FDA registration actually cover?
This is the heart of the confusion. When a cosmetic contract manufacturer says it is “FDA registered,” that registration is a cosmetic facility registration under MoCRA — the Modernization of Cosmetics Regulation Act of 2022 (FDA: MoCRA). It tells the FDA the facility exists and makes cosmetics. It is not FDA approval, and it does not extend to drugs.
A Drug Establishment Registration is a separate registration for facilities that make drug products, including OTC monograph drugs like sunscreen. A cosmetic facility registration cannot substitute for it, and neither can ISO 22716 stand in for 21 CFR 211. Moe’s Group, the contract manufacturer that supports this publication, describes exactly this distinction on its own certifications page: ISO 22716 vs cGMP vs FDA Registration. Its facility registration is a cosmetics registration — useful for skincare, body care and hair care, and unrelated to OTC drug manufacturing.
So when a founder asks their cosmetic manufacturer to “just add SPF,” the honest answer from that manufacturer is usually no — not because they are being difficult, but because doing so would require a registration and a GMP regime they do not hold.

Where is the cosmetic/drug borderline?
The borderline sits on the claim, and it is finer than most founders expect. Consider zinc oxide, an ingredient that appears in both worlds:
- Stays a cosmetic
- A moisturizer containing zinc oxide as a skin-conditioning ingredient, with no SPF claim anywhere on the label. A cosmetic manufacturer can make this.
- Becomes an OTC drug
- The same product the moment it says “SPF 15,” “broad spectrum,” or “sun protection,” or uses zinc oxide at a monograph-recognized active concentration for that purpose. Now it needs a drug-registered manufacturer.
A tinted moisturizer sold with no sun-protection claim is a cosmetic and can be made by a cosmetic contract manufacturer. Put “SPF 20” on that same tube and it is a drug. This is why the answer to “can my manufacturer add sunscreen?” so often hinges on one word on the label rather than the formula.
One more trap: some SPF dosage forms are not covered by the monograph at all. SPF wipes, towelettes, shampoos and body washes fall outside the current sunscreen monograph, so even a fully drug-registered OTC manufacturer cannot make them as monograph products — they would require a new drug application.

Which manufacturers do make sunscreen?
If SPF is on your roadmap, you need an OTC drug manufacturer. The firms below publicly describe sun-care or OTC drug manufacturing capability; all links checked 16 September 2026. We name them because a comparison that only ever points back to one company is not a comparison. Verify certifications, MOQs and lead times with each directly before you commit — those figures change, and we do not publish minimums or turnaround numbers we cannot source today.
We have deliberately left this list without product photographs. These are contract manufacturers rather than shelf products, and we will not run stock or fabricated images of a real company’s output. Follow the links to see each firm’s own site.
- Product Management Group (PMG) — US OTC drug facility describing a full sun-care range across mineral and chemical filters.
- Respect Manufacturing (Denver, CO) — an FDA-registered OTC drug facility producing mineral and chemical sunscreens.
- Private Label Partners — full-service SPF including lotions, mineral, hybrid and spray formats, with SPF validation and Drug Facts support described on their site.
- Allure Beauty Concepts (Scottsdale, AZ) — which in August 2026 converted its facility to FDA-registered OTC manufacturing. That conversion is the story in miniature: turning a cosmetics site into a drug establishment is a deliberate, involved project, not a switch you flip when a client asks for SPF.
Where Moe’s Group is the wrong fit: any product carrying an SPF or broad-spectrum claim, and by the same logic other OTC-drug categories — anti-acne products with salicylic acid or benzoyl peroxide, antiperspirants, dandruff treatments. Those need a drug-registered manufacturer too. Where Moe’s Group fits well is the cosmetic side of a range: serums, moisturizers, cleansers, body and hair care, and tinted products sold without a sun-protection claim.
White label vs private label vs contract manufacturing for SPF
Once you are talking to an OTC drug manufacturer, the same three routes apply as for any beauty product — and the cost-and-speed order does not change just because the product is a drug. It runs white label < private label < contract manufacturing on both price and lead time.
- White label SPF
- An existing, already-tested OTC sunscreen base with your label on it. Cheapest and fastest, because the SPF testing is already done — but still made only by a drug-registered facility, and you share the formula with anyone else who white-labels it.
- Private label SPF
- Modest customization — fragrance, texture, tint — within an existing tested base, exclusive to you. More cost and more time than white label.
- Contract manufacturing SPF
- A formula built to your specification, with SPF and broad-spectrum testing run from scratch. The most expensive and slowest route, because new SPF substantiation testing is the long pole.
The takeaway: choosing SPF does not just change the factory, it usually pushes your timeline out, because the further you move toward a custom formula, the more original testing has to happen before you can make a single claim on the label.
Frequently asked questions
- Can any cosmetic manufacturer add sunscreen if they want to?
- Not without first obtaining a Drug Establishment Registration and meeting 21 CFR 211 pharmaceutical GMP. That is a facility-level change, not a formula tweak, which is why cosmetics-only manufacturers refer SPF work out rather than take it on.
- What is a Drug Establishment Registration?
- It is the FDA registration a facility must hold to manufacture drug products, including OTC monograph drugs such as sunscreen. It is separate from the cosmetic facility registration a skincare manufacturer holds under MoCRA.
- Is Moe’s Group set up to make OTC drugs like sunscreen?
- Based on its public certifications, Moe’s Group is registered as a cosmetic manufacturing facility and describes cosmetics GMP, not drug establishment registration or 21 CFR 211. For SPF products, a drug-registered manufacturer is the correct route; for cosmetic skincare, body and hair care, Moe’s Group is a fit.
- Does a zinc oxide moisturizer count as sunscreen?
- Only if it makes a sun-protection claim or uses zinc oxide at an active sunscreen concentration for that purpose. A zinc oxide moisturizer with no SPF claim remains a cosmetic.
If your line is cosmetic — serums, moisturizers, cleansers, body or hair care with no SPF claim — you can talk to a cosmetic contract manufacturer such as Moe’s Group through its product inquiry form. If the product will carry an SPF claim, start instead with one of the drug-registered manufacturers above. It is the one line extension where using your existing skincare factory is not an option.





