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Sunscreen, also known as sunblock or sun cream, is a photoprotective topical product for the skin that helps protect against sunburn and most importantly prevent skin cancer. Sunscreens come as lotions, sprays, gels, foams (such as an expanded foam lotion or whipped lotion[1]), sticks, powders and other topical products. Sunscreens are common supplements to clothing, particularly sunglasses, sunhats and special sun protective clothing, and other forms of photoprotection (such as umbrellas).

The first sunscreen in the world was invented in Australia, by chemist H.A. Milton Blake, in 1932[2] formulating with the UV filter 'salol' (phenyl salicylate) at a concentration of 10%.[3] Its protection was verified by the University of Adelaide[4] and it was also produced commercially by Blake's company, Hamilton Laboratories.[5] Despite sunscreen being relatively new, sun protection practices have been observed since at least the ancient Egyptians "who used ingredients such as rice bran, jasmine, and lupine"[6] to provide sun protection.

Sunscreens are classified into two types: mineral (also referred to as physical) sunscreens (i.e., zinc oxide and titanium dioxide) and chemical (also referred to as petrochemical, as they are typically derived from petroleum[7]) sunscreens.[8]Research by the FDA on the safety of the main three organic UV filters (oxybenzone, homosalate and octocrylene) found that the three ingredients could be detected on the skin, in blood, in breast milk and in urine samples weeks after no longer being used.[9][10][11]

Medical organizations such as the American Cancer Society recommend the use of sunscreen because it aids in the prevention of squamous cell carcinomas.[12] The routine use of sunscreens may also reduce the risk of melanoma.[13] However, many sunscreens do not block ultraviolet A (UVA) radiation, yet protection from UVA is important for the prevention of skin cancer.[14]

To provide a better indication of their ability to protect against skin cancer and other diseases associated with UVA radiation (such as phytophotodermatitis[15]), the use of broad-spectrum (UVA/UVB) sunscreens has been recommended.[16] Some sunscreens include an expiration date—a date indicating when they may become less effective.[17]


History

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Sama-Bajau woman from Maiga Island, Semporna, Sabah, Malaysia, with traditional sun protection called burak
Burmese girls wearing thanaka for sun protection and cosmetic purposes.

Early civilizations used a variety of plant products to help protect the skin from sun damage. For example, ancient Greeks used olive oil for this purpose, and ancient Egyptians used extracts of rice, jasmine, and lupine plants whose products are still used in skin care today.[18] Zinc oxide paste has also been popular for skin protection for thousands of years.[19] Among the nomadic sea-going Sama-Bajau people of the Philippines, Malaysia, and Indonesia, a common type of sun protection is a paste called borak or burak, which was made from water weeds, rice and spices. It is used most commonly by women to protect the face and exposed skin areas from the harsh tropical sun at sea.[20] In Myanmar, thanaka, a yellow-white cosmetic paste made of ground bark, is traditionally used for sun protection.

The first ultraviolet B filters were produced in 1928.[21] Followed by the first sunscreen, invented in Australia by chemist H.A. Milton Blake, in 1932[22] formulating with the UV filter 'salol' (Phenyl salicylate) at a concentration of 10%.[23] Its protection was verified by the University of Adelaide.[24][25] In 1936, L'Oreal released its first sunscreen product, formulated by French chemist Eugène Schueller.[26]

Early adopters of sunscreen were the US military. In 1944, as the hazards of sun overexposure became apparent to soldiers stationed in the Pacific tropics at the height of World War II,[27][26][28][29] Benjamin Green, an airman and later a pharmacist produced Red Vet Pet (for red veterinary petrolatum) for the US military. Sales boomed when Coppertone improved and commercialized the substance under the Coppertone girl and Bain de Soleil branding in the early 1950s. In 1946, Austrian chemist Franz Greiter introduced a product, called Gletscher Crème (Glacier Cream), subsequently became the basis for the company Piz Buin, named in honor of the mountain where Greiter allegedly received the sunburn.[30][31][32]

In 1974, Greiter adapted earlier calculations from Friedrich Ellinger and Rudolf Schulze and introduced the "sun protection factor" (SPF), which has become the global standard for measuring UVB protection.[27][33] It has been estimated that Gletscher Crème had an SPF of 2.

Water-resistant sunscreens were introduced in 1977,[26] and recent development efforts have focused on overcoming later concerns by making sunscreen protection both longer-lasting and broader-spectrum, as well as more appealing to use.[27]

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Regulation

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Palau

On 1 January 2020, Palau became the first country in the world to ban sun cream that is harmful to corals and sea life. The ban came into effect immediately after an announcement by President Tommy Remengesau Jr.[34]

United States

Sunscreen labeling standards have been evolving in the United States since the FDA first adopted the SPF calculation in 1978.[35] The FDA issued a comprehensive set of rules in June 2011, taking effect in 2012–2013, designed to help consumers identify and select suitable sunscreen products offering protection from sunburn, early skin aging, and skin cancer:[36][37][38] Unlike other countries, the United States classifies sunscreen as an over the counter drug rather than a cosmetic product, resulting in less FDA approved ingredients used in sunscreen formulations .[39][40]


In 2019, the FDA proposed tighter regulations on sun protection and general safety, including the requirement that sunblock products with SPF greater than 15 must be broad spectrum and a prohibition on products with SPF greater than 60.[41]

  • To be classified as "broad spectrum", sunscreen products must provide protection against both UVA and UVB, with specific tests required for both.
  • Claims of products being "waterproof" or "sweatproof" are prohibited, while "sunblock" and "instant protection" and "protection for more than 2 hours" are all prohibited without specific FDA approval.
  • "Water resistance" claims on the front label must indicate how long the sunscreen remains effective and specify whether this applies to swimming or sweating, based on standard testing.
  • Sunscreens must include standardized "Drug Facts" information on the container. However, there is no regulation that deems it necessary to mention whether the contents contain nanoparticles of mineral ingredients. Furthermore, US products do not require the expiration date of products to be displayed on the label.[42] (The EU has stricter regulation against the use of nanoparticles, and in 2009 introduced labeling requirements for nanoparticle ingredients in certain sunscreens and cosmetics.)[43]

In 2021, the FDA introduced an additional administrative order regarding the safety classification of sunscreens. The new classification would categorize sunscreen into generally recognized as safe and effective (GRASE), not GRASE due to safety issues, or not GRASE due to additional information needed.[44] To be considered a GRASE sunscreen, the FDA requires the ingredient to have undergone both non-clinical animal studies as well as human clinical studies. The animal studies evaluate the potential for the induction of carcinogenesis, genetic and reproductive harm, and any toxic effects of the ingredient once absorbed and distributed in the body. The human trials expand upon the animal trials, providing additional information on safety in the pediatric population, protection against UVA and UVB, and the potential for skin reactions after application. In the United States, only two ingredients (Para-aminobenzoic acid and trolamine salicylate) are classified as not GRASE.[44]

Europe

In Europe, sunscreens are considered a cosmetic product rather than an over the counter drug. These products are regulated by the Cosmetic Regulation (EC) No 1223/2009, which was created in July of 2013.[42] The recommendations for formulating sunscreen products are guided by the Scientific Community on Consumer Safety (SCCS).[45] The regulation of cosmetic products in Europe requires the producer to follow six domains when formulating their product:

I. cosmetic safety report must be conducted by a qualified personnel

II. The product must not contain substances banned for cosmetic products

III. The product must not contain substances restricted for cosmetic products

IV. The product must adhere to the approved list of colourants for cosmetic products.

V. The product must adhere to the approved list of preservatives for comsetic products.

VI. The product must contain UV filters approved in Europe.[45]


According to the EC, sunscreens at a minimum must exhibit:

  1. A SPF of 6
  2. UVA/UVB ratio ≥ 1/3
  3. The critical wavelength is at least 370 nanometers (indicating that it is "broad-spectrum").
  4. Instructions for using and precautions.
  5. Evidence the sunscreen meets UVA and SPF requirements. [45]
  6. Labels of European sunscreens must disclose the use of nanoparticles in addition to the shelf life of the product. [42]

Canada

Regulation of sunscreen is dependent on the ingredient used; It is then classified and follows the regulations for either natural health products or drug product. Companies must complete a product licensing application prior to introducing their sunscreeen on the market.[45]

ASEAN (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam)

The regulation of sunscreen for ASEAN countries closely follows European regulations. However, products are regulated by the ASEAN scientific community rather than the SCCS. Additionally, there are minor differences in the allowed phrasing printed on sunscreen packages.[45]

Japan

Sunscreen is considered a cosemtic product, and is regulated under the Japan Cosmetic Industry Association (JCIA). Products are regulated mostly for the type of UV filter and SPF. SPF may range from 2 to 50. [45]

China

Sunscreen is regulated as cosmetic product under the State Food and Drug Administration (SFDA). The list of approved filters is the same as it is in Europe. However, sunscreen in China requires safety testing in animal studies prior to approval.[45]

Australia

Sunscreens are divided into therapeutic and cosmetic sunscreens. Therapeutic sunscreens are classified into primary sunscreens (SPF ≥4) and secondary sunscreens (SPF<4). Therapeautic sunscreens are regulated by the Therapeutic Goods Administration (TGA). Cosmetic sunscreens are products that contain a sunscreen ingredient, but do not protect from the sun. These products are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).[45]

New Zealand

Sunscreen is classified as a cosmetic product, and closely follows EU regulations. However, New Zealand has a more extensive list of approved UV filters than Europe. [45]

MERCOSUR

MERCOSUR is an international group consisting of Argentina, Brazil, Paraguay, and Uruguay. Regulation of sunscreen as a cosmetic product began in 2012, and is similar in structure to the European regulations. Sunscreens must meet specific standards inclusing water resistance, sun protection factor, and a UVA/UVB ratio of 1/3. The list of approved sunscreen ingredients is greater than in Europe or the US.[45]

The state of Hawaii banned the commercial sale of sunscreens containing oxybenzone and octinoxate on January 1, 2021 due to concern of environmental effects linked to the two ingredients and their contribution to increased coral bleaching.[46] This ban is only applicable to sale within the state and to sunscreen products, not other cosmetic materials.

Sunscreen can be purchased using a tax-advantaged health savings account (HSA) or flexible spending account (FSA) in the United States.[47][48]

References

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  1. ^ "WHIPPED FORMULATIONS WITH DESIRED SENSORY IMPACT". Canada Patent Data Base. July 8, 2022.
  2. ^ Rigel, Darrell S.; Weiss, Robert A.; Lim, Henry W.; Dover, Jeffrey S. (2004-01-30). Photoaging. CRC Press. ISBN 978-0-8247-5209-5.
  3. ^ Rigel, Darrell S.; Weiss, Robert A.; Lim, Henry W.; Dover, Jeffrey S. (2004-01-30). Photoaging. CRC Press. ISBN 978-0-8247-5209-5.
  4. ^ "7 Wonders of South Australia winners: Innovations - ABC (none) - Australian Broadcasting Corporation". www.abc.net.au. Retrieved 2021-07-06.
  5. ^ "History Of Hamilton". Hamilton. Retrieved 2021-07-06.
  6. ^ Aldahan, Adam S.; Shah, Vidhi V.; Mlacker, Stephanie; Nouri, Keyvan (1 December 2015). "The History of Sunscreen". JAMA Dermatology. 151 (12): 1316. doi:10.1001/jamadermatol.2015.3011. PMID 26650657.
  7. ^ Dinardo, Joe; Downs, Craig (April 2021). "Failure to Protect: Do Sunscreens Prevent Skin Cancer in Humans?". ResearchGate.{{cite web}}: CS1 maint: url-status (link)
  8. ^ Alain Ko, Stephen (2016-09-01). ""Physical" vs. "chemical" sunscreens and other sunscreen myths". KindofStephen. Retrieved 2022-01-09.
  9. ^ Matta, Murali K.; Florian, Jeffry; Zusterzeel, Robbert; Pilli, Nageswara R.; Patel, Vikram; Volpe, Donna A.; Yang, Yang; Oh, Luke; Bashaw, Edward; Zineh, Issam; Sanabria, Carlos (2020-01-21). "Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial". JAMA. 323 (3): 256–267. doi:10.1001/jama.2019.20747. ISSN 1538-3598. PMC 6990686. PMID 31961417.
  10. ^ Schlumpf, M.; Reichrath, J.; Lehmann, B.; Sigmundsdottir, H.; Feldmeyer, L.; Hofbauer, G. F.; Lichtensteiger, W. (2010). "National Library of Medicine". Dermato-Endocrinology. 2 (1): 19–25. doi:10.4161/derm.2.1.12016. PMC 3084961. PMID 21547144.
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  21. ^ Ma, Yangmyung; Yoo, Jinah (April 2021). "History of sunscreen: An updated view". Journal of Cosmetic Dermatology. 20 (4): 1044–1049. doi:10.1111/jocd.14004. PMID 33583116. S2CID 231928055.
  22. ^ Rigel, Darrell S.; Weiss, Robert A.; Lim, Henry W.; Dover, Jeffrey S. (2004-01-30). Photoaging. CRC Press. ISBN 978-0-8247-5209-5.
  23. ^ Rigel, Darrell S.; Weiss, Robert A.; Lim, Henry W.; Dover, Jeffrey S. (2004-01-30). Photoaging. CRC Press. ISBN 978-0-8247-5209-5.
  24. ^ "7 Wonders of South Australia winners: Innovations - ABC (none) - Australian Broadcasting Corporation". www.abc.net.au. Retrieved 2021-07-06.
  25. ^ "History Of Hamilton". Hamilton. Retrieved 2021-07-06.
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  27. ^ a b c Lim HW. "Quantum Leaps: New, Improved Sunscreens Have Arrived". The Skin Cancer Foundation. Archived from the original on April 14, 2012.{{cite web}}: CS1 maint: unfit URL (link)
  28. ^ Wang SQ, Hu JY. "Challenges in Making an Effective Sunscreen". The Skin Cancer Foundation. Retrieved 2014-06-12.
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  36. ^ "Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S." Food and Drug Administration. 2011-06-23. Retrieved 2012-04-10.
  37. ^ Department of Health and Human Services: Food and Drug Administration (June 17, 2011). "Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules" (PDF). Federal Register. 76 (117): 35620–35665. Retrieved August 19, 2014.
  38. ^ Department of Health and Human Services: Food and Drug Administration (May 11, 2012). "Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates" (PDF). Federal Register. 77 (92): 27591–27593. Retrieved September 27, 2012.
  39. ^ Narla, Shanthi; Lim, Henry W. (2020-01-22). "Sunscreen: FDA regulation, and environmental and health impact". Photochemical & Photobiological Sciences: Official Journal of the European Photochemistry Association and the European Society for Photobiology. 19 (1): 66–70. doi:10.1039/c9pp00366e. ISSN 1474-9092. PMID 31845952.
  40. ^ Ma, Yangmyung; Yoo, Jinah (2021-04). "History of sunscreen: An updated view". Journal of Cosmetic Dermatology. 20 (4): 1044–1049. doi:10.1111/jocd.14004. ISSN 1473-2165. PMID 33583116. {{cite journal}}: Check date values in: |date= (help)
  41. ^ LaMotte S (May 21, 2019). "Majority of sunscreens could flunk proposed FDA standards for safety and efficacy, report to say". CNN. Retrieved May 27, 2019.
  42. ^ a b c Geoffrey, Kiriiri; Mwangi, A. N.; Maru, S. M. (2019-11). "Sunscreen products: Rationale for use, formulation development and regulatory considerations". Saudi pharmaceutical journal: SPJ: the official publication of the Saudi Pharmaceutical Society. 27 (7): 1009–1018. doi:10.1016/j.jsps.2019.08.003. ISSN 1319-0164. PMC 6978633. PMID 31997908. {{cite journal}}: Check date values in: |date= (help)
  43. ^ "Is Sunscreen Safe?". Eluxe. June 8, 2014. Archived from the original on April 4, 2015.{{cite journal}}: CS1 maint: unfit URL (link)
  44. ^ a b Pantelic, Molly N.; Wong, Nikita; Kwa, Michael; Lim, Henry W. (2022-11). "Ultraviolet filters in the United States and European Union: A review of safety and implications for the future of US sunscreens". Journal of the American Academy of Dermatology: S0190962222031413. doi:10.1016/j.jaad.2022.11.039. {{cite journal}}: Check date values in: |date= (help)
  45. ^ a b c d e f g h i j Pirotta, Giulio (2020), "Sunscreen Regulation in the World", The Handbook of Environmental Chemistry, Cham: Springer International Publishing, pp. 15–35, ISBN 978-3-030-56076-8, retrieved 2023-02-14
  46. ^ Raffa, Robert B.; Pergolizzi, Joseph V.; Taylor, Robert; Kitzen, Jan M. (February 2019). "Sunscreen bans: Coral reefs and skin cancer". Journal of Clinical Pharmacy and Therapeutics. 44 (1): 134–139. doi:10.1111/jcpt.12778. PMID 30484882. S2CID 53731228.
  47. ^ Carrns, Ann (17 July 2015). "When Using a Health Savings Account, Know What Is Eligible". The New York Times.
  48. ^ Kliff, Sarah (3 December 2014). "From condoms to defibrillators, the best stuff you can buy with leftover FSA dollars". Vox.
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