Changes to US Sunscreen Regulations

Nov 1, 2011 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Title: Changes to US Sunscreen Regulations
FDAx sunscreenx critical wavelengthx SPFx labelingx
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Keywords: FDA | sunscreen | critical wavelength | SPF | labeling

Abstract: The newest regulations and comments on sunscreens from the US Food and Drug Administration (FDA) were officially published in the Federal Register on June 17, 2011, and will go into effect June 17, 2012.

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DC Steinberg, Changes to US Sunscreen Regulations, Cosm & Toil 126(11) 788 (2011)

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The newest regulations and comments on sunscreens from the US Food and Drug Administration (FDA) were officially published in the Federal Register on June 17, 2011, and will go into effect June 17, 2012. The final rule titled Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use amends the Final Monograph that went into effect in May 1999 but has been stayed until now. Parts are still stayed until the FDA issues further rules. The recently published regulations are a small part of the overall regulations; therefore, this column will clarify the overall regulations by reviewing the full picture—sunscreen drugs, labeling, registrations and unanswered questions.

US Sunscreen Requirements

In the United States, sunscreen drugs are listed in 21CFR352. This listing (see Permitted Filters) provides the allowed active ingredients and permitted combinations of these actives in addition to the required tests and labeling. Labeling and registrations will be covered later. Note that these are the drug names (not INCI) and the maximum permitted level. They must be United States Pharmacopoeia (USP) grade. A sufficient level of a UV filter must be used to give an SPF of at least 2.

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Biography: David C. Steinberg, Steinberg & Associates

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, NJ, USA, in 1995. Co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on cosmetic chemistry, Steinberg has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry. In addition, he was president of the Society of Cosmetic Chemists in 1991. Steinberg is a frequent speaker worldwide on cosmetic regulations and preservation as well as sunscreen and cosmetic ingredient chemistry. In 2009, he was honored as the first regulatory expert in personal care to be granted fellow status by the Regulatory Affairs Professional Society. He wrote the Alluredbook, Preservatives for Cosmetics, Third Edition. 

Permitted Filters

Aminobenzoic acid     ≤ 15.0%
Avobenzone                  ≤ 3.0%
Cinoxate                        ≤ 3.0%
Dioxybenzone               ≤ 3.0%
Ensulizole                     ≤ 4.0%
Homosalate                 ≤ 15.0%
Meradimate                  ≤ 5.0%
Octinoxate                     ≤ 7.5%
Octisalate                      ≤ 5.0%
Octocrylene                   ≤ 10.0%
Oxybenzone                  ≤ 6.0%
Padimate O                  ≤ 8.0%
Sulisobenzone            ≤ 10.0%
Titanium dioxide         ≤ 25.0%
Trolamine salicylate  ≤ 12.0%
Zinc oxide                    ≤ 25.0%

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