Terephthalylidene Dicamphor Sulfonic Acid
What Is It?
Terephthalylidene Dicamphor Sulfonic Acid, also called Ecamsule, is an organic compoundA compound that contains carbon and hydrogen and usually other elements such as nitrogen, sulfur and oxygen. that absorbs ultraviolet (UV) light.
Why Is It Used?
In Europe, Terephthalylidene Dicamphor Sulfonic Acid is an approved UV filterUV filters are ingredients that filter certain UV rays that are found in sunlight and, to a lesser degree, artificial light. UV filter is a general term that is used for sunscreen agents, ingredients used to protect the skin from UV rays, and ultraviolet light absorbers, ingredients use to protect products, packaging and hair from UV rays., which means that this ingredient can be added to sunscreen products that are designed to protect the skin from the sun.
In Europe, sunscreen products are considered cosmetic products. In the United States, sunscreen products are OTC drugs. Several OTC sunscreen drug products containing Terephthalylidene Dicamphor Sulfonic Acid (Ecamsule) have been approved by the FDA via the NDA process.
When used in OTC sunscreen drug products in the United States, this ingredient must be called Ecamsule.
For cosmetics and personal care products in the United States, Terephthalylidene Dicamphor Sulfonic Acid may be used as an ultraviolet light absorberIngredients that protect cosmetic products or packaging from deterioration by absorbing, reflecting, or scattering UV rays. These ingredients may also be used to protect the hair from UV rays. See also UV Filters.. In this case, the ingredient protects the product from deterioration by absorbing UV light. When used to protect the product, this ingredient is called Terephthalylidene Dicamphor Sulfonic Acid.
Scientific Facts
When applied to the skin, sunscreen ingredients absorb, deflect or scatter UV rays. In addition to causing sunburn, UV radiation is a significant cause of premature aging of the skin and contributes to the development of melanoma and other forms of skin cancer.
Safety Information
Using the New Drug Application (NDA) process for Over-the-Counter (OTC) drug approval, a company submitted data to the Food and Drug Administration (FDA) on the safety and efficacy of OTC sunscreen products containing Terephthalylidene Dicamphor Sulfonic Acid (Ecamsule).
The FDA approved several OTC sunscreen drug products which also may contain the sunscreen active ingredients, Octocrylene, Avobenzone and Titanium Dioxide, in addition to Ecamsule.
The European Commission has evaluated the safety of Terephthalylidene Dicamphor Sulfonic Acid. Based on their review, they concluded that use of this ingredient in cosmetic products as a UV light absorber at a maximum concentration of 10% would not pose a health hazard.
They also concluded that this ingredient could be used in combination with any other listed UV absorber up to the 10% concentration level.
The data submitted to the FDA as part of the NDA to support the safety and efficacy of OTC sunscreen products containing Octocrylene, Avobenzone, and Ecamsule, with or without Titanium Dioxide, included information from 28 studies in over 2500 patients, ranging in age from 6 months to over 65 years old. In addition, the contribution of each of the active ingredients to sun protection was studied.
Side effects reported during clinical studies were infrequent and non-serious.
The most common side effects in patients were acne, dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort and sunburn. 3,3′-(1,4-Phenylenedimethylene)bis[7,7-dimethyl-2-oxo-bicyclo-(2,2,1)hept-1-yl methanesulfonic acid] (Terephthalylidene Dicamphor Sulfonic Acid) and its salts are listed in the Cosmetics Directive of the European Union and may be used as a UV filter individually or in combination with other listed UV filters in cosmetics and personal care products at a maximum concentration of 10% (expressed as the acid) (see Annex VII).
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
Canada, where sunscreens are considered to be drug products, permits Terephthalylidene Dicamphor Sulfonic Acid to be used in sunscreen products at a maximum concentration of 10%.
More Scientific Information
Terephthalylidene Dicamphor Sulfonic Acid is an organic compound that functions as a sunscreen agentIngredients that are applied to the skin to absorb, to reflect, or to scatter UV rays. In the United States, sunscreen agents are regulated as Over-The-Counter (OTC) drug ingredients. and an ultraviolet light absorber. It has the ability to convert UV radiation into less damaging infrared radiation (heat).
Resources
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/