US-FDA Proposed Changes in the Labelling of Sunscreen Products

Authors

Brajesh Singh
University Institute of Pharmacy, Chhatrapati Shahu Ji Maharaj University, Kanpur, U.P
Archan Gupta
United Institute of Pharmacy
Ajay Kumar Gupta
University Institute of Pharmacy, Chhatrapati Shahu Ji Maharaj University, Kanpur,UP

Synopsis

Sunscreen products are meant to protect the skin from UV radiation from the sun, specifically UVB radiation. Sunscreens are used to supplement the body's natural defence mechanisms in order to protect against the sun's harmful UV radiation. Its ability to absorb, reflect, or scatter the sun's rays determines its function. Around 90% non-melanoma skin cancers are caused by UV radiation. The sad part is every hour a person dies because of skin cancer that is caused because of exposure to sun’s UV radiation. When the skin is exposed to harmful UVR for an extended period of time, it can cause severe damage to the skin by producing free radicals, DNA breakdown, and other factors, resulting in sunburn, pigmentation, wrinkles, dermatitis, urticaria, ageing, immune-suppression, and eventually, skin cancer. The strength of the protective effect of a sunscreen product is measured in terms of SPF (Sun Protection Factor). The labels on the sunscreen product depict the details of products; these labels are designed under the guidelines of COSMOS, and US-FDA. Recently in September 2021, US-FDA proposed a few changes in the labelling of sunscreen products which is a point of discussion as these changes will impact the sunscreen product market as well as the existing awareness of users. The US-FDA proposed change in SPF denotation, i.e., only SPF 60+ will be written for products with SPF of 60 and above while earlier specific SPF was mentioned. Other notable proposed changes are the mentions of “Skin Cancer/Skin Aging alert” in the main content. All sunscreens with an SPF value of 15+ provide broad-spectrum sun protection at a ratio of ultraviolet (UV) A1/UV of 0.7 or higher. Several other changes are also discussed in this presentation.

LR
Published
February 1, 2023