ISO 16217 Cosmetics - Immersion Procedure for Determining Water Resistance

The ISO 16217 Cosmetics - Sun protection testing methods - Immersion procedure for determining water resistance standard, published by the International Organization for Standardization (ISO), describes the immersion procedure for determining the water resistance of sunscreen products in a living organism. This standard applies to products intended for contact with human skin that contain any component capable of absorbing, reflecting, or scattering UV rays, and are also designed to be less easily removed from the skin during immersion in water or water. This standard is intended to be read in conjunction with the ISO 24444 Cosmetics - Sun protection testing methods - Determination of sun protection factor (SPF) in a living organism standard.

ISO 16217 is an international standard that defines a standardized immersion method for evaluating the water resistance of sunscreen products. This standard provides a consistent methodology for determining how well sunscreen products maintain their sun protection performance after exposure to water. It is used in conjunction with ISO 24444, which defines the method for determining the sun protection factor (SPF) of sunscreen products.

The ISO 16217 standard applies to sunscreen products that have the following characteristics:

• Products designed for application to human skin.
• Products containing components that absorb, reflect, or scatter ultraviolet (UV) radiation.
• Products marketed as water-resistant or designed to remain on the skin during water exposure.
• It requires verification of performance after immersion in water.

The main objectives of the ISO 16217 standard are:

• To establish a standardized testing procedure for the water resistance of sunscreen.
• To improve consistency among laboratories and testing organizations.
• To support reliable water-resistant claims on sunscreen labels.
• To increase consumer confidence in the performance of sunscreen.
• To facilitate the international regulatory acceptance of test results.

In principle, this standard evaluates how effective a sunscreen product remains after controlled submersion in water. Generally, the process involves the following:

• Application of sunscreen to human subjects according to defined protocols.
• Controlled immersion cycles under specified conditions.
• Post-immersion SPF testing using the methodology described in the ISO 24444 standard.
• Water resistance is determined by comparing sun protection factor (SPF) values ​​before and after exposure to water.

This procedure ensures that sunscreen products claiming waterproof properties are tested under repeatable and scientifically controlled conditions.

The ISO 16217 standard controls many important variables, including:

• Water temperature
• Immersion time
• Number of immersion cycles
• Drying procedures between immersions
• Subject preparation
• Product application requirements
• Sun protection factor (SPF) evaluation methodology

This standard reduces variability in test results between different laboratories by standardizing these parameters.

The ISO 16217 standard is widely used by:

• sunscreen manufacturers
• Cosmetic testing laboratories
• Regulatory authorities
• Certification bodies
• Research institutions
• Product development teams

This standard is particularly important for companies marketing products that claim to be waterproof or highly waterproof.

The benefits provided by the ISO 16217 standard are as follows:

• Improved consumer safety: Consumers receive more reliable information about sunscreen performance during swimming, watersports, and other water-related activities.
• International harmonization: This standard offers a globally recognized testing approach that helps manufacturers use their products in international markets.
• Reliable product claims: Manufacturers can support their waterproof claims using scientifically validated testing methods.
• Improved product development: Research and development teams can compare formulations using a consistent testing framework.
• Regulatory support: Many regulatory bodies recognize ISO-based testing methods when evaluating sunscreen product claims.

The ISO 16217 standard does not define the sun protection factor independently. Instead, it works in conjunction with the ISO 24444 standard. The ISO 24444 standard specifies the basic sun protection factor (SPF) performance. The ISO 16217 standard specifies the water immersion procedure used before reassessing the sun protection factor. Together, these standards provide a complete framework for evaluating both sun protection effectiveness and water resistance.

The ISO 16217 standard is important because it provides a standardized and scientifically validated method for evaluating the waterproofness of sunscreen products. Sunscreens are frequently used during swimming, sports, and outdoor activities. Exposure to water and sweat during these activities can reduce their effectiveness. Without a uniform testing procedure, manufacturers may make inconsistent or misleading waterproofing claims. The main reasons why this standard is considered necessary are as follows:

• Protects consumer health: The primary purpose of sunscreen is to protect the skin from harmful ultraviolet (UV) rays. If sunscreen loses its effectiveness after exposure to water, users may face risks such as sunburn, premature skin aging, UV-induced skin damage, or an increased risk of skin cancer. This standard ensures that products marketed as water-resistant continue to provide meaningful protection even after being submerged in water.
• It provides reliable water resistance claims: Statements like "water resistant" can influence purchasing decisions. This standard establishes a consistent testing methodology that allows manufacturers to support these claims with objective data.
• It establishes global consistency: Before international standards were widely adopted, different regions and laboratories often used different testing methods, making it difficult to compare results. This standard,
  • It harmonizes international testing procedures.
  • It reduces the differences between laboratories.
  • It facilitates global product registration and acceptance.
• It supports compliance with legal regulations: Regulatory bodies often require scientific evidence to support sunscreen performance claims. This standard provides a recognized testing methodology, documented procedures for laboratory evaluation, and reliable evidence for product submissions and regulatory reviews. This helps manufacturers demonstrate compliance with cosmetic and sunscreen regulations.

In conclusion, ISO 16217 is the international standard for testing sunscreen products underwater. It defines a controlled procedure for evaluating water resistance and is designed to be used in conjunction with ISO 24444 standard testing. This standard supports both consumer safety and regulatory compliance by ensuring that sunscreen water resistance claims are accurate, repeatable, and internationally acceptable.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting them in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services compliant with the ISO 16217 standard.