Recently questions are pouring in the media regarding the debatable efficiency of sunscreen widely endorsed by the experts. So far, sunscreen is the main remedy to prevent the maladies inflicted by ultraviolet (UV) radiation. The prevalence of certain sun exposure-related pathologies like malignant melanoma, is also on the rise despite the continuously increasing frequency of sunscreen use worldwide. Yes, the sun’s rays do cause photo aging. But people are now smearing on themselves and their children sunscreen chemicals, SPF 2 to 50, without any idea of their safety. UV filters and their maximum allowable concentration are established by each country or union worldwide, for example, the European Union (EU), the United States of America (USA), Australia, Canada, ASEAN, and India. In the cosmetic regulation of India, there is no fixed maximum SPF value for sunscreens.
Worldwide experts are concerned that these chemicals may be absorbed through the skin, leading to irritation of skin, hormonal disruption and even skin cancer. The US FDA (Food and Drug Administration) recently called for more research on the safety and effectiveness of these cosmetic ingredients used as UV filters like benzophenone-3 (BP-3) or octocrylene in sunscreens.
Octocrylene is an organic UV filter which absorbs mainly Ultraviolet B (UVB) radiation and Ultraviolet A (UVA) wavelengths. There is no research that shows UV filters are beneficial ingredients in cosmetics and protect from skin cancer. But octocrylene has been recently incriminated to potentially induce adverse effects on the endocrine system in addition to having allergic or photoallergic potential.
According to Ruszkiewicz et al., repeated topical octocrylene applications resulted in higher levels of urine and plasma. Once octocrylene is in the systemic circulation, it is transported to different organs. Octocrylene is highly lipophilic, and in rats, it has been detected in the liver and brain. High concentrations of BP-3 were also detected in adipose tissue after topical administration.
On the other hand, in another safety review of octocrylene as an UV filter recently published in the Journal of European Academy of Dermatology and Venereology by Berardesca E et al., octocrylene is considered as safe when used as a UV ﬁlter and cosmetic ingredients at a concentration up to 10%. In India also, according to Bureau of Indian Standards (BIS) 10 % of octocrylene in sunscreen is advisable.
As per EWG (Environment Working Group), this table shows the present evidence of the safety of octocrylene.
||Proposed status of FDA 2019
||Penetration of the skin
||Disruption of hormone
||Allergy and Other Concerns
|Octocrylene is used widely
||Insufficient data to determine safety – significant
|According to a FDA study, blood levels of octocrylene are 14 times above the cutoff for systemic exposure
Found in breast milk
||High rates of skin allergy
In February 2019, FDA released its final draft of sunscreens monograph and raised questions about 12 sunscreen filters. These 12 ingredients are some of the most commonly used UV filters, such as oxybenzone, octinoxate, octisalate, octocrylene, homosalate and avobenzone.
There are limited or no data on the absorption of the active cosmetic ingredients of sunscreen. In 2019 and 2020, FDA published two studies that shows the ingredients oxybenzone, octinoxate, octisalate, octocrylene, homosalate and avobenzone are all systemically absorbed into the body after a single use (Matta 2019, Matta 2020). The FDA also found that the sunscreen ingredients could be detected on the skin and in blood weeks after application ended (Matta 2020).
The bottom line
There is a need for detailed investigation of the safety of all sunscreen ingredients by the FDA, and more research studies to ensure that none of them damages skin or cause other toxic effects. This will help all the stakeholders, including manufacturers, practitioners, and consumers, conclude on the safety of octocrylene used as an ingredient in sunscreen.
- Ruszkiewicza J A, Pinkas A, Ferrer B, Peres T V , Tsatsakis A , Aschner M. Neurotoxic effect of active ingredients in sunscreen products, a contemporary review. Toxicology Reports. 2017; (4): 245-259.
- Berardesca E, Zuberbier T, Sanchez Viera M, Marinovich M. Review of the safety of octocrylene used as an ultraviolet filter in cosmetics. J Eur Acad Dermatol Venereol. 2019; 33 (7):25-33.
- The Trouble With Ingredients in Sunscreens. Available at:https://www.ewg.org/sunscreen/report/the-trouble-with-sunscreen-chemicals/.Accessed on August 19th , 2020.