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Sunscreen Monograph Proposed New Rules and its Impact on Formulations

by NYSCC NYSCC No Comments

Introduction

In February of 2019, the FDA stunned the cosmetics industry one more time by publishing proposed rules for sunscreens in the Federal Register.  As indicated by its name, these are only proposed rules but historically companies have implemented proposed rules into their formulations to be proactive.  The FDA used the argument that since the issuance of the original Final Monograph in 1999, the use of sunscreens and exposure to UV filters substantially increased.  It was important for the Agency to re-evaluate sunscreens based on current scientific understanding and extend safety assessments for such topical products to include chronic use.

 

What are the changes

The biggest change that the proposed ruling brought was the reduction of the number of Category I (Safe and effective) approved sunscreens that can be used in the US.  The FDA reduced the number of sunscreens in Category I from 16 to 2.  These two sunscreens are Titanium Dioxide and Zinc Oxide and they are approved at a level of 25% in formulations.  In addition, the FDA classified paminobenzoic acid (PABA) and Trolamine Salicylate as Category two II (Not safe and effective) which means that these two sunscreens can no longer be used in sunscreen formulations.  The remaining 12 sunscreens namely, Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octinoxate, Octisalate, Octocrylene, Padimate O., Sulisobenzone, Oxybenzone, and Avobenzone were classified as Category III (Additional data needed to confirm safety and efficacy).  These 12 sunscreens can be used in formulations until the FDA categorizes them into Category I or II.  From a formulation prospective, the FDA decreased the number of sunscreens to 14 until further action.  The FDA did not address the percentage at which those sunscreens can be used specifically, but probably a good fall back would be to use them at the levels published in the 1999 Monograph.  The proposed rule does not address the sunscreen active ingredients that are being evaluated under a TEA (Time and Extent Application).

In addition, the FDA proposed changes to the types of dosage forms that can be used for sunscreen products.  For Category I, they proposed the following dosage forms: oils, lotions, creams, gels, butters, pastes, ointments and sticks.  The FDA proposed Category I status for sprays subject to testing for inhalation and flammability.  Powders were classified as Category III pending additional data.  All additional dosage forms including wipes, shampoos, body washes, towelettes and others are considered as new drugs.

Broad spectrum testing was also changed.  In most parts of the world, the Critical Wavelength is used to measure broad spectrum.  The FDA is proposing to use the UVAI/UV ratio of 0.7 or higher as a standard for all sunscreens of SPF 15 or higher.  The FDA had previously proposed to make the ratio 0.9 or higher but realized that it is impossible to achieve such ratio with the portfolio of approved Category I sunscreens available in the US.  The new ratio seems reasonable but now manufacturers must perform two tests for global products, the UVAI/UV ratio and the Critical Wavelength.

Final formulation testing and labeling requirements have changed as well.  The FDA proposed to label products with the lowest SPF number achieved in in vivo testing to eliminate the variability associated with such testing.  The FDA also raised the maximum labeled sunscreen product to SPF 60+ and they attributed their decision to the lack of evidence that higher SPF product could bring meaningful clinical benefits.  The FDA proposed to label sunscreens products with an SPF 30 or higher in increments of 10 (i.e. SPF 30, 40, 50 and 60+).  They also proposed labeling sunscreens with SPF 15 to 29 to be in increments of 5 (i.e. SPF 15, 20, and 25).  The FDA also brought attention to products that are labeled SPF2 to SPF 14 and proposed that such products be removed from the market since they do not bring any adequate protection to consumers.

Sunscreens-insect repellant combination products are proposed to be classified as Category II due to incompatibility between FDA and EPA labeling instructions.  In addition, the FDA believes that combining DEET with certain sunscreens may increase cutaneous absorption of either or both.

 

What is the impact

In this proposed ruling, the FDA addressed so many safety concerns that companies and consumers suspected for years.  Many sunscreens used in the US are no longer used in Europe, Asia and the rest of the world due to their safety profiles.  However, these markets have alternative sunscreens in their portfolio that they can use to formulate safe and effective sunscreens.  In the US, such large portfolio of approved Category I sunscreen does not exist, so I would like to urge the FDA to speed the approval of all the molecules awaiting approval in the TEA process.  This will enable US formulators to have the same tools that their counterparts in the rest of the world have.  In the meantime, I am sure that formulators will use their creativity and start adapting their new formulations to the guidelines set forth by the FDA.

 

About the Author

Dr. Hani Fares started his career in personal care studying the effect of solvents on sunscreen chemicals.  His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he completed his Ph. D. in Pharmaceutics.

Dr. Fares worked at Block Drug and GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care.  After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skincare.  He is currently the Senior Director of skincare and oral care at Ashland Specialty Ingredients.  Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care.

 

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