Editing Sunscreen (section)

== Regulation ==
{{Expand section|date=January 2018}}
; Palau 
On 1 January 2020, [[Palau]] banned the manufacturing and selling of sun cream products containing any of the following ingredients: [[benzophenone-3]], [[octyl methoxycinnamate]], [[octocrylene]], [[Enzacamene|4-methyl-benzylidene camphor]], [[triclosan]], [[methylparaben]], [[ethylparaben]], [[butylparaben]], [[benzyl paraben]], and [[phenoxyethanol]].<ref>{{cite news|url=https://www.allcleartravel.co.uk/blog/palau-bans-reef-toxic-sunscreens/|title=Palau Bans 'Reef Toxic' Sunscreens|date=23 January 2020|access-date=August 9, 2023 }}</ref> The decision was taken to protect the local coral reef and sea life.<ref name="BBC News">{{cite news|url=https://www.bbc.com/news/world-asia-50963080|title=Palau is first country to ban 'reef toxic' sun cream|work=[[BBC News]]|date=1 January 2020|access-date=January 1, 2020|archive-date=November 27, 2020|archive-url=https://web.archive.org/web/20201127145518/https://www.bbc.com/news/world-asia-50963080|url-status=live}}</ref> Those compounds are known or suspected to be harmful to coral or other sea life.<ref name="BBC News"/>

; United States
Sunscreen labeling standards have been evolving in the United States since the FDA first adopted the SPF calculation in 1978.<ref>{{cite journal |author=Department of Health and Human Services: Food and Drug Administration |date=August 25, 1978 |title=Sunscreen Drug Products for Over-the-Counter Human Use |url=https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm090127.pdf |journal=[[Federal Register]] |volume=43 |issue=166 |pages=38206–38269 |access-date=July 30, 2014 |archive-date=February 22, 2017 |archive-url=https://web.archive.org/web/20170222153034/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm090127.pdf |url-status=dead }}</ref> 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.<ref name="fda20112">{{cite web |date=2011-06-23 |title=Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. |url=https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm |access-date=2012-04-10 |website=[[Food and Drug Administration]] |archive-date=April 23, 2019 |archive-url=https://web.archive.org/web/20190423132658/https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm |url-status=dead }}</ref><ref>{{cite journal |author=Department of Health and Human Services: Food and Drug Administration |date=June 17, 2011 |title=Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules |url=http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf |journal=Federal Register |volume=76 |issue=117 |pages=35620–35665 |access-date=August 19, 2014 |archive-date=October 19, 2020 |archive-url=https://web.archive.org/web/20201019123401/https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14766.pdf |url-status=live }}</ref><ref>{{cite journal |author=Department of Health and Human Services: Food and Drug Administration |date=May 11, 2012 |title=Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates |url=http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf |journal=Federal Register |volume=77 |issue=92 |pages=27591–27593 |access-date=September 27, 2012 |archive-date=July 10, 2017 |archive-url=https://web.archive.org/web/20170710130043/https://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf |url-status=live }}</ref> However, unlike other countries, the United States classifies sunscreen as an over-the-counter drug rather than a cosmetic product. As FDA approval of a new drug is typically far slower than for a cosmetic, the result is fewer ingredients available for sunscreen formulations in the US compared with many other countries.<ref>{{cite journal | vauthors = Narla S, Lim HW | title = Sunscreen: FDA regulation, and environmental and health impact | journal = Photochemical & Photobiological Sciences | volume = 19 | issue = 1 | pages = 66–70 | date = January 2020 | pmid = 31845952 | doi = 10.1039/c9pp00366e | bibcode = 2020PhPhS..19...66N | url = https://pubmed.ncbi.nlm.nih.gov/31845952 | access-date = February 20, 2023 | url-status = live | s2cid = 209388568 | archive-url = https://web.archive.org/web/20230425013950/http://pubmed.ncbi.nlm.nih.gov/31845952/ | archive-date = April 25, 2023 }}</ref><ref>{{cite journal | vauthors = Ma Y, Yoo J | title = History of sunscreen: An updated view | journal = Journal of Cosmetic Dermatology | volume = 20 | issue = 4 | pages = 1044–1049 | date = April 2021 | pmid = 33583116 | doi = 10.1111/jocd.14004 | url = https://pubmed.ncbi.nlm.nih.gov/33583116 | access-date = February 20, 2023 | url-status = live | s2cid = 231928055 | archive-url = https://web.archive.org/web/20230203152721/https://pubmed.ncbi.nlm.nih.gov/33583116/ | archive-date = February 3, 2023 }}</ref>

In 2019, the FDA proposed tighter regulations on sun protection and general safety, including the requirement that sunscreen products with SPF greater than 15 must be broad spectrum, and imposing a prohibition on products with SPF greater than 60.<ref>{{cite news | vauthors = LaMotte S |date=May 21, 2019 |title=Majority of sunscreens could flunk proposed FDA standards for safety and efficacy, report to say |work=[[CNN]] |url=https://www-m.cnn.com/2019/05/15/health/sunscreen-fda-safety-standards-study/index.html?r=https%3A%2F%2Fwww.cnn.com%2Fsearch%2F%3Fq%3DSunscreen |access-date=May 27, 2019 |archive-date=June 8, 2019 |archive-url=https://web.archive.org/web/20190608221932/https://www-m.cnn.com/2019/05/15/health/sunscreen-fda-safety-standards-study/index.html?r=https%3A%2F%2Fwww.cnn.com%2Fsearch%2F%3Fq%3DSunscreen |url-status=live }}</ref>

* To be classified as "broad spectrum", sunscreen products must provide protection against both [[Ultraviolet A|UVA]] and [[UVB]], with specific tests required for both.
* Claims of products being "[[waterproof]]" or "sweatproof" are prohibited, while the terms "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.<ref name="Geoffrey_2019">{{cite journal | vauthors = Geoffrey K, Mwangi AN, Maru SM | title = Sunscreen products: Rationale for use, formulation development and regulatory considerations | journal = Saudi Pharmaceutical Journal | volume = 27 | issue = 7 | pages = 1009–1018 | date = November 2019 | pmid = 31997908 | pmc = 6978633 | doi = 10.1016/j.jsps.2019.08.003 }}</ref>

In 2021, the FDA introduced an additional administrative order regarding the safety classification of cosmetic UV filters, to categorize a given ingredient as either:

* Generally recognized as safe and effective ([[Generally recognized as safe and effective|GRASE]])
* Not GRASE due to safety issues
* Not GRASE because additional safety data are needed.<ref name="Pantelic_2023"/><ref name=":13">{{Cite journal |last=Research |first=Center for Drug Evaluation and |date=2021-11-16 |title=Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen |url=https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen |archive-url=https://web.archive.org/web/20210924142839/https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-posts-deemed-final-order-and-proposed-order-over-counter-sunscreen |url-status=dead |archive-date=September 24, 2021 |journal=FDA |language=en}}</ref>

To be considered a GRASE active ingredient, the FDA requires it to have undergone both non-clinical animal studies as well as human clinical studies. The animal studies evaluate the potential for inducing carcinogenesis, genetic or 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. Two previously approved UV filters, para-aminobenzoic acid (PABA) and trolamine salicylate, were reclassified as ''not GRASE'' due to safety concerns and have consequently been removed from the market.<ref name="Pantelic_2023" />

'''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 2013.<ref name="Geoffrey_2019"/> The recommendations for formulating sunscreen products are guided by the Scientific Community on Consumer Safety (SCCS).<ref name="Pirotta_2020">{{cite book | vauthors = Pirotta G  |title=Sunscreens in Coastal Ecosystems |chapter=Sunscreen Regulation in the World |date=2020 |series=The Handbook of Environmental Chemistry |volume=94 |pages=15–35 |place=Cham |publisher=Springer International Publishing |doi=10.1007/698_2019_440 |isbn=978-3-030-56076-8 |s2cid=219055314 }}</ref> 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 cosmetic products.

VI. The product must contain UV filters approved in Europe.<ref name="Pirotta_2020"/>

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

# A SPF of 6
# UVA/UVB ratio ≥ 1/3
# The critical wavelength is at least 370 nanometers (indicating that it is "broad-spectrum").
# Instructions for using and precautions.
# Evidence the sunscreen meets UVA and SPF requirements.<ref name="Pirotta_2020"/>
# Labels of European sunscreens must disclose the use of nanoparticles in addition to the shelf life of the product.<ref name="Geoffrey_2019" />

'''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 sunscreen on the market.<ref name="Pirotta_2020"/>

'''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.<ref name="Pirotta_2020" />

'''Japan'''

Sunscreen is considered a cosmetic 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.<ref name="Pirotta_2020" />

'''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.<ref name="Pirotta_2020" />

'''Australia'''

Sunscreens are divided into therapeutic and cosmetic sunscreens. Therapeutic sunscreens are classified into primary sunscreens (SPF ≥ 4) and secondary sunscreens (SPF < 4).  Therapeutic 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).<ref name="Pirotta_2020" />

'''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.<ref name="Pirotta_2020" />

'''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 including 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.<ref name="Pirotta_2020" />