The topic is short and compact
Around 70 percent of respondents describe their skin as at least somewhat sensitive, with figures ranging from about 23 to over 90 percent depending on the survey.
Sensitive skin often shows increased water loss and fewer ceramides; fragrance, propylene glycol, alcohol, and acids are considered typical triggers.
A barrier formulation is created through omission: few ingredients, a skin-identical lipid system, minimal emulsifier, and preservation matched to the packaging.
As of July 31, 2026, only products featuring the extended allergen labeling in accordance with Regulation (EU) 2023/1545 may be newly placed on the market.
Tests on the finished product—such as patch tests as well as TEWL and corneometer measurements over 28 days—are reliable; supplier raw material data usually does not replace them.
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Konzeptionierung
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Bemusterung – Standardmuster in 24 h
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Individualisierung
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Prototyping
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White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
How common is sensitive skin, and what does this mean for a product range?
Sensitive skin is not a marginal group in surveys. The review paper by Farage (2019) finds, across the evaluated studies, an average of around 70 percent of respondents who describe their skin as at least somewhat sensitive. The individual studies vary between about 23 and over 90 percent because no standardized questionnaire is used, and even the wording of the question significantly alters the result. Women report sensitive skin more frequently than men.
A professional consensus definition has been available since 2017. An expert group from the International Forum for the Study of Itch described it as a syndrome in the position paper by Misery et al.: unpleasant sensations such as stinging, burning, pain, pruritus, or tingling in response to stimuli that should not normally provoke such sensations, without being explained by a skin disease. The skin can appear normal or erythematous, with the face being primarily affected.
Two points follow from this for product planning:
Self-reporting is not a diagnosis: The high rate describes a target group, not a uniform skin condition. The briefing should define whether the line primarily addresses dry, barrier-compromised skin or sensorially reactive skin.
Cosmetics remain cosmetics: According to the definition, the complaints are not explained by a skin disease. Products intended to treat a disease step outside the scope of a cosmetic product.
What happens to the skin barrier of sensitive skin?
In sensitive skin, the permeability of the stratum corneum is increased in many cases. The review by Duarte et al. (2017) describes that this allows more substances to penetrate and more water to be lost. Individuals with increased transepidermal water loss (TEWL) are more likely to react with intolerance to products, and lower ceramide levels as well as lower skin moisture have been measured in sensitive skin.
The same review identifies cosmetic products themselves as the primary triggers, especially with excessive or improper use. Alpha-hydroxy acids, propylene glycol, alcohol, and fragrances, among others, are considered potentially irritating. In addition, there are environmental triggers such as cold, wind, heat, sun, and air pollution.
This distinction is important for the formulation: barrier care can support hydration and lipid supply to the stratum corneum and avoid irritating ingredients. In contrast, sensory hyperreactivity itself has a neurophysiological basis and cannot be controlled solely via the lipid system. This boundary belongs in the positioning before the first claim is formulated. How plant-based active ingredients are categorized in barrier concepts is shown in the article on triterpenoids in skincare.
Which formulation decisions support barrier care?
A formulation for sensitive skin is built through omission and selection, not through as many active ingredients as possible. Duarte et al. recommend products with few ingredients, fragrance-free, with preferably only one active ingredient per product and without penetration enhancers such as ethanol or propylene glycol. For development, this implies the following decisions:
Decision | Typical formulation problem | Consequence for development |
|---|---|---|
Lipid system | Ceramides have low solubility and can crystallize without a suitable oil phase | Combination of ceramides, cholesterol, and fatty acids; testing the emulsion for crystals and phase separation |
Emulsifier | High amounts of emulsifier can place additional stress on the barrier | Emulsifier system with the lowest possible usage rate; ensuring stability via viscosity and storage |
active ingredients | Acids and high concentrations of retinoids or vitamin C can increase the irritation potential | Few, low-dose active ingredients, concentration matching the claim |
Fragrance | Fragrances are among the typical triggers | Fragrance-free formulation or fragrance without declarable allergens above the threshold values |
Preservation | A reduced preservative system must still pass the challenge test | Plan preservation, water activity, and packaging materials together |
Packaging materials and filling
Airless dispensers and tubes reduce contact of the bulk product with air and fingers and are factored into the microbiological risk assessment. However, they limit viscosity: very firm creams and balms cannot be dispensed from every airless system, and the flow properties of the formulation must match the dispensing mechanism. Packaging materials should therefore be tested with the original formulation as early as the sampling stage, not only after formulation approval. A related consideration regarding fragrance is described in the article on fragrance-free cosmetics.
Which tests does a formulation for sensitive skin need?
A formulation for sensitive skin requires the same basic testing as any skin care product, as well as additional evidence of skin compatibility in the target group. Accelerated stability testing over twelve weeks at elevated temperatures in the final packaging and the preservation challenge test according to ISO 11930 with evaluation after 7, 14, and 28 days are standard practice. The procedure for these basic tests is described in the article on stability and safety testing.
Skin compatibility and barrier measurement
The study by Lyu et al. (2022) demonstrates what a study design for sensitive facial skin can look like:
Subject selection: Lactic acid stinging test using 50 µl of a 10% lactic acid solution in the nasolabial fold, with water as a control on the opposite side, evaluated after 30 seconds, 2.5 minutes, and 8 minutes.
Safety: Closed patch test over 24 hours with readings at 30 minutes, 24 hours, and 48 hours after removal.
Barrier: TEWL and skin hydration (Corneometer) at baseline, after 14 days, and after 28 days, measured at 22 ± 2 °C and 50 ± 5% relative humidity.
Duration: 28 days of twice-daily application; 34 out of 35 participants completed the study.
TEWL decreased in this study from 13.49 to 8.42 g/h/m². A control group is not described for the efficacy measurement; the authors themselves mention the small sample size and the short observation period as limitations and point out that no international standard method exists for testing the efficacy of such products. For planning purposes, this means: The application phase of such a study alone takes four weeks, plus recruitment, evaluation, and reporting. The testing order should therefore be commissioned in parallel with the stability testing.
Which advertising claims are substantiated for barrier products?
Claims that describe a cosmetic function and are substantiated by tests on the finished product are defensible. According to Art. 2(1)(a) of Regulation (EC) No 1223/2009, a cosmetic product serves, among other things, to protect the skin and keep it in good condition. Barrier support, hydration, and reduced water loss fall under this, whereas the treatment of eczema or atopic dermatitis does not. Art. 20(1) also prohibits text and imagery that imply characteristics or functions that the product does not possess.
Regulation (EU) No 655/2013 requires adequate and verifiable evidence relevant to the product. A claim regarding an ingredient must not create the impression that the final product has the same properties if this is not the case. Anyone attributing properties of an ingredient to the final product must specifically substantiate this, for instance by demonstrating an effective concentration in the product. Studies from a ceramide supplier alone are therefore generally not sufficient for a barrier claim regarding the finished cream; a measurement on the finished product is more robust.
The Technical Document on Cosmetic Claims by the Working Group on Cosmetics, whose Annexes III and IV have applied since July 1, 2019, becomes more specific:
Hypoallergenic: only if the product is designed to minimize its allergenic potential, and scientifically robust data confirm a very low allergenic potential. Known allergens and substances classified as skin sensitizers should be completely avoided.
Dermatologically tested: implies tests on humans under the supervision of a dermatologist. Purely consumer self-assessment studies are not sufficient.
skin compatibility tested: means that tests under the supervision of a scientifically qualified professional on a target group have demonstrated good skin compatibility.
Free from preservatives: claims such as "low in allergens because it contains no preservatives" are deemed inadmissible under the fairness criterion because they portray all preservatives as allergens.
Which formulations are permissible beyond this is summarized in the article on cosmetics advertising claims in the EU.
What does the new allergen labeling change for sensitive product lines?
Regulation (EU) 2023/1545 expands the list of fragrance allergens that must be individually listed in the ingredients list. Labeling is required as soon as a substance exceeds 0.001 percent in leave-on products and 0.01 percent in rinse-off products. Products that do not meet the new requirements may no longer be placed on the market from July 31, 2026. Goods already on the market may still be made available until July 31, 2028.
For product lines aimed at sensitive skin, this is more than just a labeling issue:
Visibility: Each additional listed allergen is legibly displayed on the packaging for customers and retailers, which contradicts positioning for sensitive skin.
Plant-based raw materials: Extracts and essential oils can contain substances subject to labeling, even if no perfume is added. The raw material specification should therefore indicate the allergen levels.
Existing formulations: Sensitive product lines containing fragrances should be reviewed and, if necessary, reformulated by the time old stock is sold off, including obtaining new stability data.
In addition, there is the safety assessment: According to Annex I Part A No. 6 of Regulation (EC) No. 1223/2009, the safety report considers exposure including the target groups. A product line explicitly marketed for sensitive skin should therefore designate this target group in the safety report.
Labtree is a B2B cosmetics developer and cosmetics manufacturer with its own laboratory and production facilities in Germany. Formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production are all managed in one place, ensuring that the lipid system, preservation, and packaging of barrier care products are coordinated together.
Sampling: Samples of pre-qualified formulations are usually dispatched from the sample warehouse within 24 hours, and shipping of standard samples is free of charge. This allows texture and sensory profile to be evaluated early on the actual product.
White Label: A tested Labtree formulation is adapted for the brand and is typically ready for delivery in 2 to 3 months with standard packaging. The formulation remains the property of Labtree.
Private Label: The formulation is developed from scratch according to the brand's requirements, usually taking 3 to 6 months to reach market readiness. Rights and exclusivity are regulated by contract.
Testing and Documentation: Analytics, studies, regulatory documentation, and the safety report are part of the scope of services.
Quantity: The minimum order quantity is usually 1,500 units per product, depending on product type, fill size, and packaging.
The process from conceptualization through sampling, customization, and prototyping to production is described on the page Have cosmetics developed.
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FAQ
What is the difference between sensitive skin and a contact allergy?
Sensitive skin describes unpleasant sensations such as burning or stinging in response to stimuli that normally do not trigger a reaction, without the presence of a skin disease. A contact allergy is an immunological sensitization to a specific substance. For the formulation, this means: skin compatibility and allergenic potential are evaluated separately and substantiated separately.
Can a cream with ceramides claim to repair the skin barrier?
Claims regarding barrier support or reduced water loss are permissible for cosmetics if substantiated by testing on the finished product, such as a TEWL measurement. Studies provided by the ceramide supplier are generally not sufficient on their own, as Regulation (EU) No. 655/2013 requires evidence relevant to the final product. Claims concerning the treatment of eczema or atopic dermatitis categorize the product as a medicinal product.
What does “dermatologically tested” mean on packaging?
According to the Technical Document on Cosmetic Claims, the product was tested on humans under the supervision of a dermatologist, and consumers expect the results to be favorable. Consumer self-assessment studies alone do not support this claim. The test report must be included in the product information file.
Does skincare for sensitive skin have to be fragrance-free?
Not legally, but fragrances are among the typical triggers, and expanded allergen labeling makes every listed substance visible on the packaging. Many brands therefore avoid perfume altogether or select fragrance blends that contain no declarable allergens above the threshold values. The Labtree magazine article on fragrance-free cosmetics explores this trend in more depth.
Can skincare for sensitive skin do without preservatives?
Water-containing formulations need effective protection against germs that passes the challenge test according to ISO 11930. Reduced systems, low water activity, or anhydrous formats in combination with airless dispensers or tubes are possible options. According to the Technical Document, the claim "hypoallergenic because preservative-free" is considered unfair.
How long does it take to develop a barrier cream?
The duration mainly depends on whether an already tested formulation is adapted (White Label) or a formulation is created from scratch (Private Label), as stability testing and preservative challenge tests must be run completely anew for a new development. A skin compatibility study with 28 days of application plus recruitment and reporting extends the timeline if it is only commissioned after stability testing. Other time factors include the availability of raw materials and packaging materials.
