Medik8 Sunscreen and USA

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Medik8 Sunscreen and USA

As sunscreen specialists, here at Medik8, we are passionate about providing our customers all around the world with the best of the best in suncare. Each country is governed by different regulations which determine the rules regarding what can (and can’t) go into sunscreens. 

We have wanted to launch into the US market for a long time, but it has taken us a while because the US market has very different rules and regulations compared to the UK (where Medik8 is based). 

Sunscreens in the US are governed by the FDA (Federal Drug Administration) and are classified as over-the-counter (OTC) drugs, following a different set of regulations to sunscreens sold in the EU. Notably, there is a very limited set of UV filters which are allowed. Physical sunscreen filters titanium dioxide and zinc oxide are allowed. However, chemical-based sunscreens are restricted to the following set of 12 filters:

Cinoxate

Dioxybenzone (Benzophenone-8)

Ensulizole (Phenylbenzimidazole sulfonic acid)

Homosalate

Menthyl Anthranilate

Octinoxate (Ethylhexyl methoxycinnamate)

Octisalate (Ethylhexyl salicylate)

Octocrylene 

Ethylhexyl Dimethyl PABA

Sulisobenzone (Benzophenone-4)

Oxybenzone (Benzophenone-3)

Avobenzone 

Medik8 USA | Sunscreens

A lot of these chemical UV filters have some concerns regarding their safety and efficacy in formulation. For these reasons we avoid using them in our Medik8 sunscreens. For example, avobenzone is associated with instability in sunlight. There is some research to show it can lose up to 36% of its potential for UV absorption after only 1 hour of exposure to sunlight.[1] There are some concerns surrounding the safety and environment impact on the coral reefs of oxybenzone and octinoxate.[2,3,4] They have recently been banned in Hawaii because of this. 

At Medik8, we only use a select few modern chemical UV filters which we believe are the future of suncare. We only use phenylbenzimidazole sulfonic acid (Ensulizole, which is on the US-approved list), diethylamino hydroxybenzoyl hexyl benzoate (Uvinul® A Plus), bemotrizinol (Tinosorb® S) and ethylhexyl triazone (Uvinul® T150). 

Traditional sunscreens in the US primarily use avobenzone to get significant levels of UVA protection. Uvinul A Plus is a powerful alternative chemical UVA absorber which avoids the photostability issues of avobenzone.[5] It’s also known to be non-irritating or sensitising on the skin.[6] Tinosorb S and Uvinul T150 cover the UVB spectrum and have none of the safety or environmental issues associated with some of the older filters. We choose all of our sunscreen filters with the lens that they have to be safe, non-irritating, powerful absorbers and kind to the coral reefs. 

Unfortunately, Uvinul A Plus, Tinosorb S and Uvinul T150 are not yet approved for use within the US market. The issue is that it takes a lengthy amount of time for the FDA to approve new UV filters. This results in fewer filters to choose from and hence unfortunately the US market does not yet have access to the more modern chemical filters. We hope that eventually the FDA will approve these modern filters for an improved, new generation of suncare. All of our chemical UV filters are fully approved for use by the EU and other bodies throughout the rest of the world. 

And this is why unfortunately none of our sunscreen products with chemical UV filters are available yet to purchase in the US. The good news is that our physical filters are approved by the FDA; and therefore our Physical Sunscreen is available in the US. 

Our Physical Sunscreen offers broad spectrum, SPF 50+ protection, in an elegant, moisturizing  texture that makes this a sunscreen you will truly love wearing every day. Based on zinc oxide, it is formulated without controversial nanoparticles; instead formulated with optimally-sized molecules that give a light, velvety texture. The sunscreen is fragrance-free, water-resistant for up to 80 minutes and boosted with anti-pollution technology, all whilst providing powerful protection from damage caused by UV exposure.


REFERENCES

[1] L. Von Oppen-Bezalel et al, IBR web-publication, Phytoene and Phytofluene the COLORLESS CAROTENOIDS - Anti Aging and Photo Protection - a New Way of Stabilizing Sunscreens, Available from, as of 8 Feb, 2018:

(http://www.in-cosmetics.com/__novadocuments/35820?v=635137232454270000)

[2] M. Krause et al., Sunscreens: Are They Beneficial for Health? An Overview of Endocrine Disrupting Properties of UV-Filters, International Journal of Andrology, 2012, 35, pp 424-436

(https://www.ncbi.nlm.nih.gov/pubmed/22612478)

[3] M. Schlumpf et al, In Vitro and in Vivo Estrogenicity of UV Screens, Environmental Health Perspectives, 2001, 109(3), pp 239-244

(https://www.ncbi.nlm.nih.gov/pubmed/11333184)

[4] C. A. Downs et al, Toxicopathological Effects of the Sunscreen UV Filter, Oxybenzone (Benzophenone-3), on Coral Planulae and Cultured Primary Cells and Its Environmental Contamination in Hawaii and the U.S. Virgin Islands, Archives of Environmental Contamination and Toxicology, 2016, 70(2), pp 265-288

[5] C. Martins Kawakami et al, Diethylamino hydroxybenzoyl hexyl benzoate (DHHB) as additive to the UV filter avobenzone in cosmetic sunscreen formulations - evaluation of the photochemical behavior and photostabilizing effect, European Journal of Pharmaceutical Sciences, 2017, 99, pp 299-303

(https://www.ncbi.nlm.nih.gov/pubmed/28042100

[6] The Danish Environmental Protection Agency, Ministry of Environment and Food, Survey and health assessment of UV filters, 2015

(https://www2.mst.dk/Udgiv/publications/2015/10/978-87-93352-82-7.pdf)

 


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