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New FDA Regulations are on the Horizon for OTC Sunscreens

FDA published a press release about new proposed regulations which will ensure that non-prescription, over-the-counter (OTC) sunscreen products are not only safe, but effective in late February of 2019. The proposed regulations would impact and update the regulatory requirements for the majority of sunscreen products in the U.S., which are marketed without FDA-approved applications.

Regulations Need to Change with Consumer Behavior

Broad spectrum sunscreens with sun protection factor (SPF) values of 15 or higher are known to aid in the prevention of skin cancer and skin damage from sun exposure. A greater number of people are using sunscreen more frequently, and they’re using more of it with each application.

The proposed updated sunscreen regulations address:

  • Dosage forms
  • SPF and broad-spectrum requirements
  • Safety of active ingredients in sunscreens
  • Product labeling for easy identification of key product information

An Overview of Proposed Changes to Sunscreen Regulations

FDA has proposed the following changes for OTC sunscreen products that are marketed without FDA-approved applications:

Dosage Forms

  • Generally recognized as safe and effective (GRASE) sunscreen dosage forms include lotions, oils, sprays, creams, gels, butters, ointments, sticks, and butters
  • Additional information is being sought for powders
  • Wipes, body washes, shampoos, towelettes, and other dosage forms are proposed to be new drugs due to a lack of data available to FDA

Maximum SPF

  • Raise maximum SPF value on sunscreen labels from SPF 50+ to SPF 60+

Broad Spectrum Protection

  • Sunscreens with SPF of 15+ must provide broad spectrum protection
  • UVA protection must increase with SPF values

Active Ingredients

  • 2 of the 16 marketed active ingredients, zinc oxide and titanium dioxide, are GRASE
  • 2 of the 16 marketed active ingredients, PABA and trolamine salicylate, are not GRASE due to safety issues
  • The other 12 marketed active ingredients don’t have sufficient safety data to make GRASE determination, and FDA has asked for additional data from both industry and other interested parties

Sunscreen Product Label Requirements

  • Active ingredients must appear on the front of the package, similar to other OTC drugs
  • For sunscreens that haven’t been shown to help prevent skin cancer, the front label must have a notification for consumers to read the skin cancer/skin aging alert
  • Revised SPF, broad spectrum and water resistance statements must be present

Insect Repellent Sunscreen Combination Products

  • Products that combine sunscreens with insect repellents are not GRASE in the proposed regulations

Sunscreen Testing

  • FDA’s expectations for sunscreen testing and record-keeping will be clarified to provide well-defined guidance for organizations that perform sunscreen testing

The Impact of Proposed Regulations on Consumers

The proposed FDA sunscreen regulations will result in safer, more effective sunscreen products for consumers, and the labeling requirements in the proposed regulations will easily provide consumers with essential information. However, skin-cancer prevention is more than just wearing sunscreen, and should include wearing hats that provide adequate shade, protective clothing, and sunglasses.

How Proposed Regulations will Impact the Sunscreen Industry

The proposed FDA OTC sunscreen requirements will impact the sunscreen industry, particularly in terms of which ingredients are considered GRASE. If your sunscreen product contains either of the 2 ingredients that have already been identified as not being GRASE, modifying your sunscreen product formula is a strategy that can keep you in compliance with regulations while maintaining market share.

Avomeen’s industry-leading expert formulation scientists have extensive experience developing safe and effective sunscreen products. Are you interested in exploring your options? Let’s talk.



Our featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.

Learn more about Katie’s expertise and experience.