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Allantoin — Gentle Skin Protectant and Soothing Agent

A well-established skin-conditioning ingredient listed in the U.S. FDA OTC Skin Protectant Monograph. Allantoin is valued for its soothing, moisturising, and mild keratin-softening properties, and is found in thousands of cosmetic products across all categories.

Data sources: EU CosIng (#31411), CIR Safety Assessment (2010), U.S. FDA OTC Monograph, and SkinSenseDiary internal evaluation. Last updated: April 2026.

At a Glance

Also Known As
Glyoxyldiureide, 尿囊素
CAS Number
97-59-6
CosIng Functions
Skin Conditioning, Humectant, Soothing
Source
Natural (comfrey) / Synthetic
Korean Name
알란토인
Regulation
Not listed in Annex II/III (EU); FDA OTC Monograph 0.5–2%

What Is Allantoin?

Allantoin (INCI: Allantoin, CAS 97-59-6) is a diureide of glyoxylic acid, also known as (2,5-dioxo-4-imidazolidinyl)urea. It is found naturally in comfrey root (Symphytum officinale), sugar beet, wheat sprouts, and chamomile. Most cosmetic-grade Allantoin is produced synthetically via oxidation of uric acid, yielding a high-purity white crystalline powder. The CIR Expert Panel (2010) concluded that Allantoin and its related complexes are safe as used in cosmetics.


Allantoin has a long regulatory history. It is listed in the U.S. FDA OTC Skin Protectant Monograph as a recognised active ingredient at concentrations of 0.5% to 2% for minor cuts, burns, and skin irritation. In the EU, it is registered in CosIng (#31411) with approved functions including skin conditioning and soothing, and is not listed in Annex II (prohibited) or Annex III (restricted), meaning it has no specific concentration limits in cosmetic products. It has been used in pharmaceutical and cosmetic formulations for over 70 years.


Allantoin functions through multiple mechanisms: it may support keratinocyte renewal and the skin's natural repair cycle, it has mild keratin-softening (keratolytic-like) properties that help smooth rough skin by facilitating the shedding of dead surface cells, and it acts as a humectant contributing to skin hydration. CIR industry survey data indicate Allantoin is used across a wide range of product categories — from moisturisers and cleansers to sunscreens and baby care products — at typical concentrations of 0.1% to 2%.

What Does Allantoin Do for Your Skin?

🌿

Soothes Irritation

Allantoin helps calm irritated and inflamed skin. Its soothing properties make it a staple in after-sun products, post-procedure care, and formulations for reactive skin. The FDA recognises it as a skin protectant that temporarily protects minor skin irritation.

💧

Moisturises & Softens

As a humectant, Allantoin helps attract and retain moisture in the stratum corneum, contributing to softer and smoother skin texture. It is often combined with other moisturising agents in formulations for dry skin.

Smooths Rough Texture

Allantoin has mild keratin-softening properties (keratolytic-like effect) — it supports the gentle loosening of dead skin cells from the surface, helping to smooth rough or flaky patches. Compared to dedicated exfoliants such as AHAs or BHAs, this effect is very mild, making it suitable for sensitive skin.

🛡️

Supports Skin Renewal

Allantoin may support keratinocyte renewal and the skin's natural repair process (limited evidence). This is one of the reasons it is commonly included in wound care and post-procedure formulations, though the degree of effect depends on concentration and formulation.

Generally suitable for: Most skin types, including sensitive, dry, irritated, and acne-prone skin. Allantoin is one of the gentlest active ingredients available and is widely used in baby care products. Individual tolerance may vary depending on the overall formulation.

Is Allantoin Safe?

1 / 10

Low Hazard

The CIR Expert Panel (2010) reviewed all available safety data and concluded that Allantoin and its related complexes are safe as used in cosmetics. Allantoin is listed in the U.S. FDA OTC Skin Protectant Monograph as a recognised active ingredient (0.5–2%). Not listed in EU Annex II (prohibited) or Annex III (restricted).

Our rating is based on
CIR — Cosmetic Ingredient Review
Safe as Used (2010)
CIR reviewed Allantoin and 7 related complexes. Safety test data and previous assessments were considered sufficient to support the safety of Allantoin in cosmetic product categories at concentrations in current use. Industry survey reported use concentrations up to 5%.
EU Cosmetics Regulation
No Restrictions
Not listed in Annex II (prohibited), III (restricted), or IV. Registered in CosIng as #31411. Unrestricted use across all EU cosmetic product categories.
Allergen & Sensitivity
Generally Well-Tolerated
No allergen flags in our database. The CIR report noted that Allantoin is non-irritating and non-sensitising in clinical patch tests. The Ames mutagenicity test was negative. One GHS code exists (H302: Harmful if swallowed) — this relates to oral ingestion toxicity, not topical cosmetic use.
CosIng
Approved Functions
Skin Conditioning · Humectant · Soothing — EU CosIng approved functions for this ingredient in cosmetic products.
GHS Hazard Flags
H302 — Acute Toxicity (Oral)
Harmful if swallowed
This hazard classification applies to oral ingestion, not to topical cosmetic application. Allantoin has low acute oral toxicity (LD50 in rats reported at approximately 5,000 mg/kg). This is a standard classification for many cosmetic raw materials and does not indicate risk when used as directed on skin.

Things to Know

Allantoin is historically derived from comfrey root (Symphytum officinale), but comfrey also contains pyrrolizidine alkaloids (PAs) which are toxic to the liver. Cosmetic-grade Allantoin is produced synthetically and does not contain PAs. If you encounter "comfrey extract" products, note that these are distinct from purified Allantoin.

While some literature describes Allantoin as supporting keratinocyte renewal, the evidence is limited. It should be understood as supporting the skin's natural renewal cycle — it is not a pharmacologically active growth factor. The degree of effect depends on concentration and the overall formulation.

Pregnancy & Nursing

Allantoin is generally considered a low-risk topical ingredient during pregnancy and nursing. The CIR 2010 report noted oral developmental toxicity studies in rats and rabbits at doses well above cosmetic exposure levels showed no teratogenic effects. As a topical cosmetic ingredient, systemic absorption is expected to be minimal. However, no dedicated clinical trials have specifically studied pregnant human populations. Consult your healthcare provider for personal advice.

Sources & References
Look up this ingredient on each authoritative source:
🔗 EWG Skin Deep🔗 PubMed🔗 EU CosIng🔗 ECHA🔗 FDA🔗 AAD🔗 CIR
Safety data compiled from CIR Safety Assessment of Allantoin (Final Report, 2010), U.S. FDA OTC Monograph, EU CosIng Database, and SkinSenseDiary internal analysis. This is for educational purposes only and does not constitute medical advice. Last updated: April 2026.

Pairing Guide for Allantoin

✓ Great Pairings

Panthenol (Provitamin B5)

Two gentle soothing agents that complement each other. Panthenol adds moisturising depth while Allantoin contributes skin-protecting properties. A classic combination in sensitive skin formulations.

Ceramides

Allantoin soothes and supports skin renewal while ceramides rebuild the lipid barrier. Together they provide comprehensive repair for dry or compromised skin.

Niacinamide (Vitamin B3)

Niacinamide strengthens the skin barrier and helps with uneven tone; Allantoin soothes and conditions. No conflicts — they work well in the same formulation.

Retinol

Allantoin's soothing and protective properties can help offset the dryness and irritation that retinol may cause. Using an Allantoin product alongside retinol is a common strategy to improve tolerability.

⚠ Use with Care

Very Low pH Formulations

Allantoin's stability may be affected in very low pH environments (formulation-dependent). If using strong acid exfoliants, consider applying them at separate times of day as a precaution.

Comfrey Extract (Whole Plant)

Do not confuse purified Allantoin with whole comfrey extract. Comfrey contains pyrrolizidine alkaloids that are hepatotoxic. Synthetic Allantoin is PA-free and safe for cosmetic use.

Popular Products with Allantoin

Found in thousands of products across our database. Allantoin is one of the most widely used soothing ingredients in skincare. Here are some well-known options (ingredient lists verified via INCI):

Aveeno
Calm + Restore Gentle Smooth PHA Exfoliating Cleanser
Cleanser
Aveeno
Daily Care Moisturising Lotion
Moisturizer
CeraVe
AM Facial Moisturizing Lotion SPF 50
Moisturizer
Cetaphil
Advanced Defence Serum (AM)
Serum
Bioderma
ABCDerm Gentle Cleanser
Cleanser
Aveeno
Baby Daily Care Moisturising Lotion
Moisturizer

Frequently Asked Questions

Is Allantoin safe for sensitive skin?
Yes. Allantoin has a SkinSenseDiary safety rating of 1/10 (Low Hazard). The CIR Expert Panel (2010) concluded Allantoin and its related complexes are safe as used in cosmetics. It is non-sensitising and non-irritating in clinical patch tests. Allantoin is listed in the U.S. FDA OTC Skin Protectant Monograph as a recognised active ingredient (0.5–2%). No allergen flags exist in our database. It is one of the gentlest active ingredients available and is widely used in baby care products.
Can I use Allantoin every day?
Yes. Allantoin is gentle enough for daily use, including twice-daily application. It has a long history of use in dermatological and cosmetic products with no reports of cumulative irritation. It is commonly found in everyday products such as moisturisers, cleansers, and sunscreens designed for daily use.
Can I use Allantoin with Retinol?
Yes. Allantoin's soothing and skin-protecting properties make it a useful companion for retinol, which can cause dryness and irritation. Using an Allantoin-containing product can help calm the skin and support its barrier during retinoid use. There are no known conflicts between these two ingredients.
Is Allantoin safe during pregnancy?
Allantoin is generally considered a low-risk topical ingredient during pregnancy and nursing. The CIR 2010 report noted that oral developmental toxicity studies in rats and rabbits showed no teratogenic effects at doses well above cosmetic exposure levels. As a topical cosmetic ingredient, systemic absorption is expected to be minimal. However, no dedicated clinical trials have specifically studied pregnant human populations. Consult your healthcare provider for personal advice.
What is the difference between Allantoin and Panthenol?
Both are gentle, well-tolerated ingredients commonly used for soothing and skin conditioning. Allantoin is a diureide of glyoxylic acid listed in the FDA OTC Skin Protectant Monograph; it soothes irritation and has mild keratin-softening properties. Panthenol (provitamin B5) converts to pantothenic acid in the skin and is valued for its moisturising properties. They are often used together in formulations for sensitive or irritated skin, as they have complementary mechanisms.
What concentration of Allantoin is used in skincare?
The U.S. FDA OTC Skin Protectant Monograph lists Allantoin at 0.5% to 2%. In cosmetic formulations, concentrations typically fall within this range. CIR industry survey data reported use concentrations up to 5% in some product categories. These are observed industry usage levels, not recommended concentrations — the effective range for most skincare products is 0.5–2%.

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