What Does “Dermatologically Tested” Really Mean?

What Does the Label “Dermatologically Tested” Mean?

Have you ever seen the label “dermatologically tested”? The testing of skincare products by dermatologists aims to ensure that the product is suitable and safe to use on the skin. The “Dermatologically tested” label is not given directly without actual testing on human skin. Clinical testing is mandatory to obtain this label, while testing using chemical instruments only serves as supporting data.

Applicable Testing Standards and Regulations

This testing is important to ensure user safety, product effectiveness, and product stability. Testing laboratories have standards and assessments of irritation and allergy potential to determine whether the product is safe to use or not. By using international standards such as ISO/TR 24475:2021 and the EU Cosmetic Regulation (1223/2009), this testing is handled directly by dermatology specialists. According to the Regulation of the Food and Drug Supervisory Agency (BPOM) Number 3 of 2022 concerning Technical Requirements for Cosmetic Claims, claims that provide product functionality with an efficacy period, claims related to testing by dermatologists ‘dermatologically tested’, and others must be accompanied by a product testing report.

Types of Dermatological Tests

Types of tests that are mandatory to obtain the “Dermatologically tested” label include patch test, repeated insult patch test (RIPT/HRIPT), stinging test, and in-use test. This series of tests is conducted to observe and evaluate the effects caused when the product is applied to human skin. Parameters observed include signs of irritation such as redness, itching, rashes, stinging, or allergic reactions (sensitization). 

Clinical testing on subjects with sensitive skin involves participants with a history of dermatitis and rosacea. Products intended for sensitive skin in particular need to undergo a stinging test. The test subjects are people with sensitive skin, and the assessment of stinging or burning sensation is carried out by the user over a specific period under the supervision of a dermatologist.

In addition, this testing also considers repeated product use in real daily life conditions. Therefore, the in-use test becomes an important part of the assessment process. Subjects will use the product as usual for several weeks, and during this period their skin will be observed by a dermatology specialist to see if there are any long-term adverse reactions.

Read more:
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The Importance of the “Dermatologically Tested” Claim for Consumers and Manufacturers

The claim “dermatologically tested” is not only intended to increase consumer trust but is also part of the manufacturer’s responsibility to ensure product safety. The label serves as an initial indicator for consumers in choosing safe products. Therefore, this claim must be supported by scientific data and testing processes that can be ethically and regulatorily accounted for. 

However, it must be understood that this label does not automatically mean the product is free from irritants or allergens; rather, it only indicates that the product has undergone limited trials on a certain group without showing significant reactions. Since each individual’s skin condition and response may vary, it is still possible for a skincare product with the “dermatologically tested” label to cause adverse skin reactions. Hence, it is recommended to consult independently with a dermatologist or perform a self-conducted patch test on areas such as behind the ears, hands, or back before full application. 

Reading the list of ingredients printed on the packaging can also be a preventive step to avoid allergens for individuals. Consumers still need to be cautious, especially those with specific skin conditions, such as allergies, eczema, or high sensitivity to certain ingredients. Ensure your product has undergone dermatological testing in a reputable laboratory.

Read more:
3 Characteristics of a Cosmetic Testing Laboratory Your Brand Deserves Trust

Laboratory testing is a crucial step in ensuring that the product is truly safe to use and worthy of the “dermatologically tested” claim.Valid and reliable test results will strengthen consumer confidence in your product.

author: delfia
editor: sabilla reza

References:

Peraturan Badan Pengawasan Obat dan Makanan (BPOM). 2022. Peraturan Badan Pengawasan Obat dan Makanan Nomor 3 Tahun 2022 Tentang Persyaratan Teknis Klaim Kosmetika. Diakses pada 24 April 2025. Tautan dapat diakses pada : https://standar-otskk.pom.go.id/storage/uploads/9fafd640-6c8b-4853-ae1f-9a2f9255db46/PerBPOM-No.-3-tahun-2022.pdf

Europian Union. 2009. Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products. Official Journal of the European Union. Diakses pada 24 April 2025. Tautan dapat diakses pada : https://health.ec.europa.eu/system/files/201611/cosmetic_1223_2009_regulation_en_0.pdf

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