New Sunscreen Labeling Rules Issued

A new Broad Spectrum label and SPF 15 or higher means the product are beneficial against skin cancer, early skin aging, and sunburn.

The U.S. Food and Drug Administration announced a new regulation June 14 that allows sunscreen products meeting modern standards for effectiveness to be labeled with new information to help consumers reduce the risk of skin cancer, early skin aging, and sunburn. The regulation allows sunscreen products that pass FDA's test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled "Broad Spectrum."

Both UVB and UVA contribute to sunburn, skin cancer, and premature skin aging, but sunburn mainly reults from UVB radiation. Sunscreens labeled as both Broad Spectrum and SPF 15 or higher, if used regularly as directed and in combination with other sun protection measures, will be beneficial against all of these, FDA said.

"FDA has evaluated the data and developed testing and labeling requirements for sunscreen products so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families."

Products with SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products labeled as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. A product that is not Broad Spectrum (or is Broad Spectrum but has an SPF between 2 to 14) will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

"Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves," Woodcock said. "Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF of 15 or higher, they should also limit sun exposure."

A companion proposed rule would limit the maximum SPF value on sunscreen labels to "50 +" because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50, according to the agency.

The new regulations will become effective for most manufacturers in one year. Manufacturers with annual sales less than $25,000 have two years to comply.

Download Center

HTML - No Current Item Deck
  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Steps to Conduct a JSA

    We've put together a comprehensive step-by-step guide to help you perform a job safety analysis (JSA), which includes a pre-built, JSA checklist and template, steps of a JSA, list of potential job hazards, and an overview of hazard control hierarchy.

  • Everything You Need to Know about Incident investigations

    Need some tips for conducting an incident investigation at work after there’s been an occupational injury or illness, or maybe even a near miss? This guide presents a comprehensive overview of methods of performing incident investigations to lead you through your next steps.

  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - November December 2020

    November December 2020

    Featuring:

    • COLD STRESS
      Managing Cold Stress
    • TRAINING: FALL PROTECTION
      Providing Training for Fall Protection
    • PPE: HEARING PROTECTION
      Eight Tips for Hearing Testing Day
    • FACILITY SECURITY
      Incorporating COVID-19 Protections into Safety Programs
    View This Issue