我尝试了FDA时隔二十余年终于批准的新型防晒成分。

内容来源:https://lifehacker.com/health/new-sunscreen-ingredient-fda-approved?utm_medium=RSS
内容总结:
美国防晒市场迎来革新:FDA批准新型高效防晒剂,消费者有望用上"日系爆款"同款产品
美国食品药品监督管理局(FDA)近日传来一项令护肤爱好者振奋的消息:一种在欧洲和亚洲已安全使用数十年的防晒剂——双-乙基己氧苯酚甲氧苯基三嗪(俗称"天来施S"或bemotrizinol),终于获准加入美国防晒产品的可用成分清单。这意味着,美国消费者未来将有机会在本土购买到配方更先进、使用感更佳的防晒产品。
长期以来,以日本"碧柔水感防晒精华"为代表的亚洲防晒产品在欧美护肤社群中拥有大量拥趸,其核心优势正是添加了这种新型化学防晒剂。使用者普遍称赞此类产品质地轻薄、不黏腻、不泛白,且能提供稳定的广谱防护(同时抵御导致晒伤的UVB射线和导致皮肤老化的UVA射线),综合体验远超美国市面多数产品。
此次获批的bemotrizinol被皮肤科专家视为"理想防晒成分"。它不仅与其他防晒成分兼容性好,能调配出更轻盈的质地,其光稳定性也优于现有许多化学防晒剂,防护更持久。更重要的是,它在提供高效广谱防护的同时,完全避免了矿物防晒剂(如氧化锌)可能产生的泛白问题,实现了化学防晒的透明质感与矿物防晒的广谱稳定性之间的平衡。
在安全性方面,该成分自2000年起已在欧亚多国广泛使用,积累了长期安全数据。FDA此次批准后,它将成为继氧化锌和二氧化钛之后,第三种被认定为"公认安全有效"的防晒成分。
美国防晒新品审批长期滞后(上一次批准新成分是1996年),主要源于其将防晒产品按药品而非化妆品监管的严格流程。2020年通过的《CARES法案》为部分非处方药开辟了加速通道,使得已有充分国际安全使用数据的bemotrizinol得以更快进入美国市场。
根据流程,FDA相关规则预计在2026年底前完成最终定稿。届时,美国消费者将有望在本地货架上购买到添加这一创新成分的防晒产品,亲身感受此前只能通过海外购获得的"爆款"防晒体验。这标志着美国防晒产业即将迎来近三十年来最重要的成分升级,防晒产品的质地与效能有望实现跨越式提升。
中文翻译:
美国食品药品监督管理局(FDA)传来一则意外喜讯:防晒成分双-乙基己氧苯酚甲氧苯基三嗪(俗称天来施S)终于获准加入美国市场防晒产品的许可成分清单。这种成分在欧洲和亚洲已使用数十年,正是碧柔水感防晒精华等防晒产品中的核心活性成分——这类防晒霜因具备美国本土产品无法企及的特质而拥有大批忠实拥趸。
我曾亲身体验过日版碧柔水感防晒精华(产品全称)。这款防晒霜在护肤论坛和亚洲美妆社区备受推崇,因其质地清爽不黏腻,且能同时抵御UVA和UVB紫外线而不会产生泛白现象。我的那支来自旅行归国或海外代购的朋友——在美国实体店根本买不到。
下文将详述个中缘由,但首先必须强调:它的确与我们本土产品截然不同。即便标榜"清爽"的美国防晒霜也难免厚重黏腻,而这款产品涂抹后仿若无物。我瞬间理解了它备受追捧的原因。怀着这份记忆,我期待该成分获准后能为美国防晒市场带来革新。
双-乙基己氧苯酚甲氧苯基三嗪究竟有何特别?
据皮肤科专家向《女性健康》杂志解释,这种成分具有多重优势:其一"能与其他防晒成分完美协同",这正是碧柔防晒质感轻盈舒适的原因。为直观展示差异,可参考皮肤科医生对比日版与美国版碧柔防晒的视频——成分差异直接导致质地天差地别。
其二在广谱防护方面更卓越。当前美国防晒配方中,所有活性成分均能防护导致晒伤的UVB,但仅少数可抵御引发皱纹与皮肤老化的UVA。虽然UVB被视为皮肤癌主要风险源,两者实则都致癌。目前美国广谱防晒多采用氧化锌等矿物成分,虽防护力尚可,但足量涂抹时易产生泛白问题。
作为化学紫外线过滤剂,该成分不仅避免泛白现象,更能同时高效防护UVA与UVB。其光稳定性优于现有多数化学防晒剂,持久防护力更强。换言之,这款化学防晒剂兼具化学防晒与物理防晒的双重优势。
安全性方面亦属佼佼者。虽然所有市售防晒产品都比不涂更安全,但美国现有化学防晒成分因需进一步研究确认安全性,目前仅氧化锌和二氧化钛两种矿物成分被公认为安全有效。而该成分将成为第三种获此认定的防晒剂。
需注意的是,在查阅欧美防晒成分表时,该物质可能标注为Tinosorb S或bis-ethylhexyphenol methoxyphenyl triazine。
为何迟至今日才获批准?
近二十年来,护肤界对美国防晒产品的普遍诟病在于错失国际优质成分(美国上次批准新型防晒成分还是1996年)。多数国家将防晒品归为化妆品监管,美国却将其列为药品管理,这意味着需要更严苛的测试与审批流程。
2020年颁布的《冠状病毒援助、救济与经济安全法案》为非处方药开辟了绿色通道:只要FDA确认其安全有效,即可免去完整审批流程。该成分自2000年起在欧亚澳多地安全使用的记录,使其顺利符合标准。虽然FDA相关法规尚待最终确认,但预计2026年底前,含该成分的新型防晒产品就将登陆美国市场。
英文来源:
Some unexpected good news from the FDA: bemotrizinol, a sunscreen ingredient that has been used in Europe and Asia for decades, is finally being added to the allowable ingredients list for products sold in the U.S. Bemotrizinol is the active ingredient in sunscreens like Bioré Watery Essence, which has a cult following for being unlike anything we can get in the U.S.
I’ve tried Bioré UV Aqua Rich Watery Essence (that’s the full name of the product) in its original Japanese formulation. This sunscreen is a cult favorite on skincare and Asian beauty forums because of its non-greasy feel, and because it protects against both UVA and UVB rays without leaving a white cast. I got mine from a friend who had either picked it up while traveling or possibly ordered from overseas; you can’t buy it in U.S.-based stores.
I’ll explain why this is below, but first: it truly is nothing like anything we have locally. Even our most “non-greasy” sunscreens tend to feel a little goopy or sticky. This one really feels like nothing after you rub it in. I instantly understood why it’s so sought-after. Remembering that experience, I’m looking forward to what we might see in American sunscreens once manufacturers are allowed to include this ingredient.
What’s so special about bemotrizinol?
Bemotrizinol has a lot of things going for it. One is that it “plays well with other sunscreen ingredients,” as one dermatologist told Women’s Health. You can make lighter, nicer-feeling sunscreens with it, hence the popularity of the Bioré formulation I tried. To see what I mean, check out this video where a dermatologist shows off the differences between Bioré's Japanese formulation and the version it sells in the U.S. The ingredients are different, and the texture just isn't the same.
It’s also more effective at broad-spectrum protection. With our current sunscreen formulations, all active ingredients protect against UVB rays (the rays that cause sunburn) but only a few can also provide protection against UVA rays (which contribute to wrinkling and aging of skin). UVB is considered to be the bigger risk for skin cancer, but both probably contribute to cancer risk. Right now, most broad-spectrum U.S. sunscreens use mineral components like zinc oxide. Mineral sunscreens work pretty well, but can leave a white cast on your skin when applied as thickly as you’re supposed to.
Bemotrizinol is a chemical UV filter, so it doesn’t leave that white cast. But it protects well against UVA rays in addition to UVB, and it’s more photostable than a lot of our existing chemical sunscreen ingredients so it can last longer on the skin. In other words, it’s a chemical sunscreen, but combines some of the best features of both chemical and mineral sunscreens.
It’s also considered to be one of the safest sunscreens. All sunscreens on the market are much safer than going without sunscreen, but all of our chemical sunscreen ingredients are currently undergoing a safety evaluation because regulators determined they are probably fine but need more research to know for sure. Currently only our two mineral sunscreen ingredients (zinc oxide and titanium dioxide) are considered GRAS, or generally recognized as safe and effective. Bemotrizinol will be the third.
If you're looking at ingredient lists on Asian or European sunscreens, be aware that it goes by several names. Tinosorb S is bemotrizinol; so is bis-ethylhexyloxyphenol methoxyphenyl triazine.
Why it’s taken so long
Ask anyone in the skincare world what they think about U.S. sunscreens, and for decades now you’d get complaints that we’re missing out on the best sunscreens that the rest of the world uses. (Our last new sunscreen ingredient was approved in 1996.) In most countries, sunscreens are regulated as cosmetics, but in the U.S. they are regulated as drugs. That means the U.S. requires more rigorous testing and approval.
The CARES act, passed in 2020 for pandemic relief, provided a way for over-the-counter drugs to be sold without going through the complete approval process, so long as the FDA was satisfied they were safe and effective. Bemotrizinol met the criteria, thanks in large part to the fact that it’s been used safely since 2000 in Europe, Asia, and Australia. The FDA’s rule on bemotrizinol still needs to be finalized, but it seems likely we’ll see new sunscreens on shelves before the end of 2026.
文章标题:我尝试了FDA时隔二十余年终于批准的新型防晒成分。
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