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Urea moisturizing cream OEM/ODM manufacturing
Urea Moisturizing Cream · OEM/ODM
Urea is a small water-attracting molecule that is naturally present in the stratum corneum as part of the skin's natural moisturizing factor (NMF). Cosmetic-grade urea is synthesized from ammonia and carbon dioxide and purified by crystallization (PubChem); it is not taken from animal sources. Its effect changes with concentration: according to the review by Celleno (2018), up to 10% urea acts as a moisturizer, while above 10% it has a keratolytic effect; the Cosmetic Ingredient Review (CIR) safety report recorded use in cosmetics at 0.01% to 10%. For facial skin, Butter-C's urea article gives a clear answer: it can be used, at a low concentration as a humectant. Urea is also more than a passive humectant: in 21 healthy volunteers applying it for 4 weeks, a 20% urea cream reduced transepidermal water loss while 10% made no significant change, and both levels increased the skin's own defense peptides (Grether-Beck et al., 2012). 20% is above the moisturizing range, so these are data on urea in a study, not the effect of a face cream. A urea face cream has three specific tasks: keeping urea stable in a water-rich emulsion for the whole shelf life, controlling stinging — a frequent complaint with urea — and allowing for the fact that urea increases the penetration of other ingredients in the formula. This page differs from the general moisturizing cream page because urea is the named ingredient, and from the urea body lotion and foot cream pages in skin area and urea level. Butter-C offers turnkey OEM/ODM manufacturing, from formula development and testing to labeled finished goods and the notification dossier.
Formula base
Low-level urea, with the buffer and cream base built around its stability
The general moisturizing cream page lists low-level urea as one of many humectants. Here urea is the named ingredient, so the urea level, pH, mixing temperature and the humectants that go with it are all chosen for facial skin.
Urea — the named ingredient
INCI Urea (carbamide, CAS 57-13-6), very soluble in water (about 545 g/L at 25 °C). Not listed in ASEAN Annex II, III or VI (06/2026 release); not to be confused with thiourea (Annex II Ref 321), carbamide peroxide (under the hydrogen peroxide entry, Annex III Ref 12), the preservative imidazolidinyl urea (Annex VI Ref 27) or Hydroxyethyl Urea (a different INCI). Urea is not yet in Butter-C's current raw material list: source and certificate of analysis (COA) are confirmed per order.
Urea level for the face
Up to 10% is the moisturizing range (Celleno, 2018), and a face cream sits in the lower part of it. The levels tested in people in the sources checked — 4% urea with 4% sodium chloride (Loden et al., 2002), 5% urea with ceramide NP and lactate applied to the forearms of people over 60 (Danby et al., 2016) — were not trials on facial skin. The urea level of a face cream is therefore set by tolerance and stinging tests on the finished product itself, not taken from a ready-made number.
pH buffer
In the study by Panyachariwat and Steckel (2014), urea was more stable at pH 4–8 and degraded least in a lactate buffer at pH 6.0. Sodium Lactate is a salt of lactic acid and falls under ASEAN Annex III entry A6 — the lactate, expressed as acid, is added to the total AHA; a citrate buffer can be chosen to stay outside this entry, in which case urea stability has to be proven by stability testing.
Glycerin and lipids alongside
In a randomized double-blind trial in 197 people with atopic dermatitis, a 20% glycerin cream and a cream with 4% urea + 4% sodium chloride had the same effect on skin dryness, but moderate-to-severe smarting occurred in 24% of users of the urea–saline cream versus 10% with the glycerin cream (Loden, 2002). Glycerin therefore carries part of the moisturizing work so urea can stay at a low level; ceramide NP, squalane and light oils soften the skin and seal in moisture.
Oil-in-water emulsion for the face
Non-ionic emulsifiers, fatty alcohol at a low level, and Xanthan Gum, which tolerates the buffer's electrolytes better than Carbomer. Phenoxyethanol – Ethylhexylglycerin preservative system, checked by a preservative challenge test (formulation experience).
Key technical points
Four points specific to urea in a face cream
Among creams that all "contain urea", stability, stinging and what goes into the formula with urea decide whether a cream feels comfortable or stings, and whether it keeps its quality until the end of its shelf life.
Keeping urea stable for the shelf life
Urea breaks down in solution and is less stable at higher temperatures (Panyachariwat and Steckel, 2014). Urea is therefore added to the water phase once the emulsion has cooled, with the pH set between 4 and 8 and buffered. From formulation experience, urea breakdown products can make the pH drift upward and give an ammonia smell — two signs monitored together with urea assay during stability testing.
Stinging is a common complaint
The CIR report (2005) noted that burning was the most frequently reported effect when urea was used on diseased skin; 5% urea was slightly irritating and 20% irritating in some reports. A review by Loden (2003) lists sensory reactions from urea, lactic acid and low pH among the reasons people find a moisturizer hard to accept. Butter-C tests stinging on the finished product and the label says: stop using if stinging persists.
Urea increases penetration of other ingredients
The CIR panel cautioned formulators that urea can increase skin absorption of other substances; urea itself is absorbed at 9.5% through normal skin versus 67.9% through abraded skin. Facial skin often also receives serums, AHAs and retinoids: our urea article notes that the sources checked did not directly assess these combinations, so Butter-C recommends a fragrance-free version and reassesses safety when the client wants to add actives.
The skin barrier depends on the whole formula
Loden (1996): on normal skin, two urea creams reduced transepidermal water loss after 10 and 20 days and made skin less reactive to the detergent sodium lauryl sulphate. But a 7-week trial in 78 people found that a simplified cream that also contained 5% urea increased transepidermal water loss, while an ordinary 5% urea cream did the opposite (Buraczewska et al., 2007). The effect on the barrier belongs to the whole formula and has to be measured on the finished product.
Three formulation directions
Three ways to put urea into a face cream
Light urea – glycerin moisturizer
Low-level urea with glycerin, a lactate buffer and a light, quickly absorbed cream texture for normal to dry skin, morning and evening. A short formula with few ingredients alongside urea; stinging still has to be tested on the finished product.
Urea – ceramide cream for dry skin
Following a formula type tested in people: a 5% urea cream with ceramide NP and lactate hydrated the skin more and for longer than a control cream without these ingredients in people over 60 with dry skin (Danby, 2016 — applied to the forearm, a result of the whole formula). The face version keeps urea at the level set by tolerance testing and adds squalane and a light butter for a softer texture.
Urea gel-cream with NMF components
Urea combined with other components of the natural moisturizing factor such as Sodium PCA, Sodium Lactate and glycerin, in a low-oil gel-cream base for combination skin and hot, humid climates. Total lactate expressed as acid is counted under entry A6.
Packaging is planned with the formula
Airtight tubes or pump bottles limit finger contact with the cream; packaging is filled with samples in the stability study to track odor and pH under the actual conditions of sale.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters Butter-C monitors during formula development and scale-up to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- pH over time
- Measured at 25 °C at production and at each stability time point; an upward pH drift is a sign that the buffer needs revisiting.
- Urea content
- Assayed at the start and after stability testing to confirm the remaining urea matches the figure on the label.
- Odor
- Checked for ammonia odor after storage at 40 °C and freeze–thaw cycling.
- Viscosity & emulsion stability
- Rotational viscometer at 25 °C; centrifugation, freeze–thaw cycling, storage at 40 °C; monitoring for separation and color change.
- Tolerance, stinging
- Stinging and smarting after application assessed on volunteers under the testing facility's protocol; the eye area is avoided.
- Total AHA (if lactate is used)
- With a lactate buffer: a calculation of the A6 total expressed as acid is kept in the dossier.
- Microbiology & preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy test under ISO 11930.
- Packaging compatibility
- Filled into the actual tube or bottle; checks for pump force, tightness and material odor.
Claims
Writing claims within cosmetic scope
Much of the urea literature comes from people with atopic dermatitis, people with diabetes or high-strength urea preparations for thickened skin and nails — a medical setting that does not translate into claims for a face cream. Butter-C reviews the wording on the label and in marketing materials when preparing the notification dossier.
Moisturizes and helps dry skin hold moisture
Instead of: restores skin, promises to fix dry skin at the root.
Helps skin feel softer and smoother (sensory, tested on the finished product)
Instead of: exfoliates, "peels away" — a face cream uses urea in the moisturizing range and is not positioned as keratolytic.
Supports the skin barrier — when there are data measured on the formula
Instead of: boosts filaggrin, boosts the skin's defense peptides (the Grether-Beck 2012 data are for urea in a study).
Contains X% urea
State the exact percentage matching the assay after stability testing. Instead of: dryness-reduction figures borrowed from studies of other formulas.
Directions and cautions on the label
Try on a small area of skin first; avoid the eyes and scratched or cracked skin; stop using if stinging persists; people using a topical product prescribed by a doctor, and pregnant women, should ask a doctor. Instead of: suitable for every skin type, "for sensitive skin", safe for babies.
Target users described as normal to dry skin
Instead of: statements about effects on atopic dermatitis, ichthyosis or keratosis — these conditions need a dermatologist.
Manufacturing specifications
Our capabilities
- Texture
- Light cream, rich cream or gel-cream; dry-touch or softer for dry skin.
- Pack formats
- Tubes, pump bottles, jars. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order — depends on the formula direction and the pack format chosen.
- Testing
- Performed at a GLP / ISO 17025-accredited laboratory, with the results delivered with every batch.
- Dossier
- Product Information File (PIF) and notification dossier prepared by Butter-C, including stability results that track pH, odor and urea content.
- Packaging
- Label design, printing and packing run in parallel with formula work; the patch-test and broken-skin cautions are laid out from the first label draft.
Suggested product concept
Fragrance-free urea – ceramide moisturizer for dry facial skin
A product concept to help you picture the possibilities, not a ready-made product for sale. The actual formula is developed to match your brand positioning and price range.
Low-level urea and Glycerin
Urea as the named ingredient in the moisturizing range, its level set by stinging tests on samples; glycerin as the companion humectant.
Ceramide NP and Squalane
Lipids that soften and seal in moisture for dry skin; "supports the skin barrier" is used only when measured on this cream itself.
Lactate buffer around pH 6
The pH range where urea degraded least in the Panyachariwat and Steckel study; the lactate level is kept low so the A6 total stays below 2.5% expressed as acid (a cautious reading), so no sunburn warning is required.
50 ml tube, fragrance-free
No fragrance to limit stinging triggers; an airtight tube, with a patch-test caution on the label.
Customization options
What you can specify
The same product type can serve very different customer groups depending on the brand. Tell us your requirements in the areas below and our team of pharmacists will develop a matching formula.
Urea level
A low level within the moisturizing range, set by tolerance testing on the finished product; a face cream is not made at keratolytic levels.
Buffer
Lactate buffer (urea stays stable, but it counts toward entry A6) or citrate buffer (stability has to be proven); this decides the calculation in the dossier and the label wording.
Combinations
Glycerin, Sodium PCA, Panthenol, ceramides, squalane; other actives are reassessed because urea increases penetration.
Texture
Gel-cream for combination skin, light cream for daytime or richer cream for night.
Fragrance
Fragrance-free recommended; if a fragrance is needed, a fragrance-free version is developed in parallel.
Ingredient preferences
Paraben-free, mineral-oil-free, silicone-free, vegan — please state these at the outset.
Further reading
Related topics
Urea in cosmetics
How it moisturizes, the 10% boundary, human evidence, stability and safety (in Vietnamese).
Moisturizing cream manufacturing
General page: humectants, emollients, occlusives — urea is one of many options.
Urea body lotion manufacturing
Urea for the whole body, with levels up to the 10% ceiling of the moisturizing range.
Foot cream manufacturing
Thick skin, higher urea levels and combination with lactic acid.
Sodium lactate in cosmetics
The lactate buffer for urea and how to convert it to lactic acid (in Vietnamese).
The skin barrier
Structure of the stratum corneum, the natural moisturizing factor and how to keep the barrier healthy (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details →
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