Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526205.htm
Timestamp: 2019-04-22 10:01:52+00:00

Document:
This letter concerns your firm’s marketing of the KLĒNSKIN sunscreen product line, including “KLĒNSKIN™ SunBar™ SPF 20 Soap,” “KLĒNSKIN SPA™ Showeron™ Sunscreen Broad Spectrum SPF 30 Shampoo, Face & Body Wash Water Resistant (80 MIN),” “KLĒNSKIN Kids Showeron™ Sunscreen Broad Spectrum SPF 30 Shampoo, Face & Body Wash Water Resistant (80 MIN),” and “KLĒNSKIN™ Showeron™ Sunscreen Broad Spectrum SPF 30 Shampoo, Face & Body Wash Water Resistant (80 MIN)” (collectively, the KLĒNSKIN products).
The U.S. Food and Drug Administration (FDA) conducted an inspection of (b)(4), from September 29 - November 17, 2015. Your firm contracted with (b)(4) to manufacture the over-the-counter (OTC) drug product “KLĒNSKIN SPA™ Showeron™ Sunscreen Broad Spectrum SPF 30 Shampoo, Face & Body Wash Water Resistant (80 MIN).” The FDA Investigator collected the labeling for that product during the inspection. In addition, your firm’s website (http:\\www.Klenskin.com) markets additional KLĒNSKIN products.
As described below, the KLĒNSKIN products are unapproved new drugs because the products are ineligible for the OTC Drug Review for Sunscreens, are not generally recognized as safe and effective for use to help provide protection from sunburn, and we are not aware of FDA-approved applications on file for these products. As such, the use of KLĒNSKIN products may not help protect consumers from sunburn and may cause users to be susceptible to sunburn and other disease conditions.
Your firm’s introduction of these unapproved new drugs into interstate commerce is in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(d) and 355(a)].
The KLĒNSKIN products are labeled “Helps prevent sunburn.” Based on this labeling, KLĒNSKIN products are “drugs” as defined by section 20l(g)(l)(B) of the FD&C Act [21 U.S.C. § 321(g)(l)(B)], because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or any function of the body of man. Specifically, this product is intended for use to help provide protection from sunburn.
Based on the claims made for these products, the KLĒNSKIN products are "new drugs" within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they have not been used to a material extent or for a material time for their labeled use to help prevent sunburn, and also because they are not generally recognized as safe and effective for that use. The newness of a drug may arise among other reasons by reason of the newness of a dosage or method or duration of administration or application [see 21 CFR 310.3(h)(5)].
As the Agency specifically noted in 2011, nonprescription drug products intended for use to help prevent sunburn that are marketed in dosage forms including body washes and shampoos are not currently eligible for review under the OTC Drug Review for Sunscreens because FDA is not aware of evidence that a sunscreen in the form of a shampoo or a body wash existed in the OTC drug marketplace on or before May 1972 (76 FR 35669 at 35671, June 17, 2011). Also, nonprescription drug products intended to help prevent sunburn that are marketed in the form of soaps are not currently eligible for review under the OTC Drug Review for Sunscreens because FDA is similarly not aware of evidence that a sunscreen in the form of a soap existed in the OTC drug marketplace on or before May 1972. In addition, OTC sunscreen products in these dosage forms have not established eligibility for review under the Time and Extent Application (TEA) process (21 CFR 330.14(c)) or under the procedure set out by the Sunscreen Innovation Act (SIA) (21 U.S.C. 360fff) because we have not received any TEAs or any requests for review under the SIA for these products. OTC sunscreen products in these dosage forms that are marketed without an approved application therefore remain subject to regulatory action unless and until the requirements of the SIA or § 330.14(h) are satisfied.
Under sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)], new drugs may not be introduced or delivered for introduction into interstate commerce unless applications approved by FDA and submitted under section 505(b) or 505(j) of the FD&C Act [21 U.S.C. § 355(a)] are in effect for these products. Without such applications, there is a lack of adequate data to establish eligibility of or general recognition of the safety and effectiveness of KLĒNSKIN products for OTC use to help prevent sunburn. Therefore, these products may not help protect consumers from sunburn, and may cause consumers to be susceptible to sunburn and other disease conditions caused by the sun. Based on our information, there are no FDA-approved applications on file for the KLĒNSKIN products. The marketing of these products without approved applications violates these provisions of the FD&C Act.
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute the KLĒNSKIN products and provide the date(s) and reason(s) you ceased production.
If you have any questions regarding any issue in this letter, please contact William V. Millar, Compliance Officer, at (510) 337-6896, by fax at (510) 337-6703, or by email at william.millar@fda.hhs.gov.
 For general information on the Agency’s proposed approach to the enforcement of nonprescription sunscreen products marketed without approved applications see Draft Guidance for Industry: Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application , available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm259001.pdf (published for notice and comment purposes only).

References: § 321
 § 321
 § 321
 § 330
 § 355
 V.