WARNING LETTER
Waxhead Sun Defense Company
MARCS-CMS 688286 —
March 12, 2025
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Kari Kenner, CEO
Recipient Title
Shannon Kenner, CEO
Waxhead Sun Defense Company
614 Santa Maria Dr
Fernandina Beach
,
FL
32034
United States
mac@gowaxhead.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
March 12, 2025
RE: 688286
Dear Mr. and Mrs. Kenner:
This letter is to advise you that in May 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://gowaxhead.com/ where your “Waxhead SUN DEFENSE SHAMPOO + CONDITIONER + BODY WASH + UV PROTECTION SUN DEFENSE BODY WASH with zinc oxide” (hereinafter “Waxhead Sun Defense Body Wash”) product is available for purchase in the United States without a prescription.
Your “Waxhead Sun Defense Body Wash” product is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in 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 it is intended to affect the structure or any function of the body.
Examples of the claims from the product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:
“Scalp Sunscreen…Our Zinc Shampoo provides your hair and skin with daily UVA/UVB/UVC protection, creating a barrier against the sun's harsh rays…” [from your “Waxhead Sun Defense Body Wash” product website]
Embrace the Waxhead Experience…∙ Boosts daily UVA/UVB/UVC protection: Safeguard your face, skin, and hair from incidental sun exposure.” [from your “Waxhead Sun Defense Body Wash” product website]
“Waxhead Zinc Body Wash and Shampoo is the game-changer you've been waiting for…With our innovative scalp sunscreen and zinc body wash combination, you can effortlessly protect your skin from the sun's harmful rays without the need for sunscreen lotions…” [from your “Waxhead Sun Defense Body Wash” product website]
“Added Layer of UV Protection… Our Zinc Body Wash and Shampoo boosts UV protection for the face, skin, and hair and helps protect areas difficult to cover with sunscreen, such as the scalp and ears.” [from your “Waxhead Sun Defense Body Wash” product website]
Based on the above labeling, your “Waxhead Sun Defense Body Wash” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1,2 However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.3 To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a shampoo or face/body wash dosage form. As previously stated, there is no FDA-approved application in effect for your drug product.
Thus, even if your product were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “Waxhead Sun Defense Body Wash” sunscreen drug product is a misbranded drug introduced or delivered for introduction into interstate commerce in violation of sections 502(ee) and 301(a) of the FD&C Act, 21 U.S.C. 352(ee) and 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
____________________
1
See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.
2
We note that your “Waxhead Sun Defense Body Wash” also appears to include intended uses as an antifungal, for the control of dandruff and psoriasis, and for acne. OTC antifungal drug products, dandruff and psoriasis drug products, and acne drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in their respective final administrative orders: Over-the-Counter Monograph M005: Topical Antifungal Drug Products for Over-the-Counter Human Use; Over-the-Counter Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use; and Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use, respectively. There are no provisions in any of the respective categories’ monographs, nor any monograph, that allow for a combination sunscreen, antifungal, control of dandruff and psoriasis, and acne drug product.
3
Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6024 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6024 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act.
Content current as of:
03/18/2025
Regulated Product(s)
Drugs
Over-the-Counter Drugs