Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.
Photodermatol Photoimmunol Photomed. 2020 Jan;36(1):42-52. doi: 10.1111/phpp.12503. Epub 2019 Sep 16.
Broad spectrum sunscreens with a sun protection factor (SPF) of 15 or greater are indicated to decrease the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures. To determine whether sunscreen product performance is compromised under solar exposure and to test spectral uniformity of protection across the UVA spectrum, we tested broad spectrum sunscreens with a variety of active pharmaceutical ingredients (APIs) and in a variety of dosage forms.
A cross-sectional market survey of 32 sunscreen drug products containing either organic or inorganic APIs with SPFs of 15, 30, 50, and 70 was tested. UV doses were delivered via natural sun in Silver Spring, Maryland between June and September of 2017.
Of the 32 sunscreen drug products, 6 products failed to meet their broad spectrum claim under solar exposure. Using FDA's new proposal to strengthen sunscreen broad spectrum requirements, spectral uniformity based on the mean sunscreen absorbance of UVA1(340-400 nm)/UV (290-400 nm) indicated that ~40% of sunscreen drug products tested had suboptimal UVA protection.
US consumers may unknowingly be receiving up to 36% more transmitted UVA when selecting between similarly labeled broad spectrum sunscreen drug products with equivalent SPF values. FDA's new proposal may help decrease consumers' overall lifetime UVA burden. Spectral absorbance data on sunscreen performance can be used to further improve the coupling of broad spectrum protection to a product's SPF value so that consumers have improved proportional increases in UV protection.
广谱防晒霜,防晒因子(SPF)为 15 或更高,如按指示与其他防晒措施一起使用,可降低因阳光引起的皮肤癌和皮肤过早老化的风险。为了确定防晒霜产品在阳光照射下的性能是否受到影响,并测试 UVA 光谱范围内的保护光谱均匀性,我们测试了含有各种活性药物成分(API)和各种剂型的广谱防晒霜。
对含有有机或无机 API、SPF 为 15、30、50 和 70 的 32 种防晒霜进行了横断面市场调查。2017 年 6 月至 9 月,在马里兰州银泉市通过自然阳光进行了紫外线剂量输送。
在 32 种防晒霜中,有 6 种产品在阳光照射下未能满足其广谱要求。使用 FDA 加强防晒霜广谱要求的新提案,基于 UVA1(340-400nm)/UV(290-400nm)的平均防晒霜吸收率的光谱均匀性表明,约 40%的防晒霜产品的 UVA 保护效果不佳。
美国消费者在选择具有等效 SPF 值的类似标签广谱防晒霜时,可能会不知不觉地接收到高达 36%的更多透射 UVA。FDA 的新提案可能有助于减少消费者的整体终生 UVA 负担。防晒霜性能的光谱吸收数据可用于进一步改善广谱保护与产品 SPF 值的结合,从而使消费者获得更好的 UV 保护比例增加。