April 6, 2021

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63-64, 1976. 209-218, 2005. Fisher, A.A., “Sunscreen Dermatitis: Para-Aminobenzoic Acid and its Derivatives,” Cutis, vol. Dermal exposure to oxybenzone (in acetone) in rats and mice and oral feeding of oxybenzone to rats and mice resulted in reduced sperm density in males in 13-week general toxicity studies conducted by the National Toxicology Program (NTP) (Ref. (3) Pipet 3 mL of the oxybenzone solution and 7 mL of the padimate O solution into a 100-mL volumetric flask. ... Eczema cream (2 oz.) Reactive oxygen species are “a type of unstable molecule that contains oxygen and that easily reacts with other molecules in a cell. Similar to dermal sensitivity testing described above, photoallergy tests use an induction/rest/challenge/rechallenge multiphase design to assess erythema, edema, and vesiculation. Brown, J.S., T. Gordon, O. Raney, S., P. Lehman, and T. Franz, “30th Anniversary of the Franz Cell Finite Dose Model: The Crystal Ball of Topical Drug Development,” Journal of Drug Delivery Science and Technology, vol. The Over-the-Counter (OTC) ... Generic Comparable of Benadryl Cream: Anti-Itch Cream: 28g: $5: 8B: Generic Comparable of Bacitracin: Bacitracin: 14g: $6: 8C: Generic Comparable of Lotrimin : Clotrimazole 1% Cream: 28g: $7: 8D: Generic Comparable of Cortisone: Hydrocortisone Cream: 28g: $5: 8E: Generic Comparable of Zinc Oxide: Zinc Oxide Ointment : 28g: $8: 8F: Generic Comparable of … 193. Also, many times, the painful symptoms of shingles respond quite well to these NSAIDS. 9. 1(3), pp. 154. Proposed § 201.327(i)(1)(i) requires responsible persons to, among other things, ensure that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Debra Rose Wilson, Ph.D., MSN, R.N., IBCLC, AHN-BC, CHT. This can be a 2-year study or a shorter (usually 6 months) alternative carcinogenicity model, and it should be conducted in a species different from that used in the dermal carcinogenicity study. 53, 54, and 55). Mitchnick, M.A., D. Fairhurst, and S.R. 10, p. 12, 2013. To address this, avobenzone is typically combined with a photostabilizer to prevent rapid photodegradation (Refs. We have no evidence, however, that this in fact occurs in sunscreen products containing titanium dioxide or that there are any other negative impacts resulting from such photocatalytic activity. For information on the availability of this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/​federal-register/​cfr/​ibr-locations.html. In determining the specific testing and other data needed to adequately demonstrate that an OTC sunscreen active ingredient is safe, FDA considers both the circumstances under which OTC sunscreen products are intended to be used by consumers (i.e., the conditions of use) and current scientific knowledge and assessment technology. Some are also available over the counter (OTC) for home use. 84(2), pp. While you may not be able to prevent future outbreaks completely, take comfort in knowing fast relief is available. We estimate the total burden of this recordkeeping to be 2,925 hours. By requiring that all sunscreens with SPF values of 15 or more satisfy the (new) broad spectrum standard (including the new ratio requiring proportionate protection), this proposal will also enable consumers to select a product primarily by numerical (SPF) value on the label, having assurance that, when used as directed, a product labeled with a higher numerical SPF value provides proportionately more protection not only against sunburn, but also against skin cancer and skin aging than lower numbered products [41] 4. “Identifying Gaps in Consumer Knowledge About Sunscreen,” Journal of the American Academy of Dermatology, vol. The Over-the-Counter (OTC) ... Generic Comparable of Benadryl Cream: Anti-Itch Cream: 28g: $5: 8B: Generic Comparable of Bacitracin: Bacitracin: 14g: $6: 8C: Generic Comparable of Lotrimin : Clotrimazole 1% Cream: 28g: $7: 8D: Generic Comparable of Cortisone: Hydrocortisone Cream: 28g: $5: 8E: Generic Comparable of Zinc Oxide: Zinc Oxide Ointment : 28g: $8: 8F: Generic Comparable of … 4. 1006, 2012. The current requirements for sunscreen labeling include directions that the product should be applied to all skin exposed to the sun, that it should be used “regularly” to decrease the risk of skin cancer and early skin aging,[27] Wear shorts under a dress or skirt. 107. Additional specificity has been proposed here to clarify how the more general recordkeeping provisions of part 211 apply to final formulation testing. In our view, as a matter of good clinical practice, IRB approval should already be routinely currently obtained for clinical final formulation testing under current § 201.327 because it is essential to producing results that are scientifically sound and ethically appropriate. Agren, M.S., “Influence of Two Vehicles for Zinc Oxide on Zinc Absorption through Intact Skin and Wounds,” Acta Dermato-Venereologica, vol. Quicker responses to adverse events, improved inspections, and better protection of human subjects. 219-226, 2012. Proposed Maximum SPF and Broad Spectrum Requirements, D. Proposed Requirements Related to Final Formulation Testing and Recordkeeping, E. Proposed Status of Sunscreen-Insect Repellent Combination Products, X. Tewari, A., R.P. (2) The product does not meet the definition of the term “extremely flammable” as defined in § 352.3(f). (5) Testing in accordance with part 211 of this chapter must confirm that the product meets the conditions for particle size, flammability, and drying time as required by this section and reflected in the product labeling. IR3535 is classified in Toxicity Category IV (practically nontoxic) for acute oral, dermal, and inhalation toxicity and Category III (slightly toxic) for eye irritation (Ref. 51 and 52). Accordingly, we clarify in proposed § 201.327(l) that records documenting proper maintenance of equipment used in final formulation testing must be kept, consistent with existing obligations in 21 CFR 211.68. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It does so by numbing the skin, as an analgesic. The data submitted were similar and in some cases overlapping. However, in that study, the sunscreen and insect repellent ingredients were applied separately and were not part of a combination product (Ref. Over-the-counter antibiotic creams, gels, and ointments may help clear up a small patch of folliculitis. We estimate the total burden of this recordkeeping to be 41,040 hours. 360fff-5), as amended by the SIA (21 U.S.C. 76. For each subject, determine the final MEDu,ss MEDp, andtp MEDp by administering a series of five UV doses to the appropriate test sites. Finally, as discussed further in section VIII.D, if the sunscreen active ingredient is determined to be GRASE for use in sunscreens, the sunscreen monograph, when finalized, must set out the conditions under which any future sunscreen containing that active ingredient will be GRASE and not misbranded. This proposed approach accounts for situations in which investigators and other personnel conducting final formulation testing are employees of the responsible person. 11/05/2021, 235 (ii) HPLC assay. Before they can be marketed, most skin-applied insect repellents must be registered by EPA, although a few plant-derived insect repellent active ingredients are exempt from registration because EPA has determined they present minimum risk potential to humans (Ref. FDA estimates a burden of 0.5 hours per response. The purpose of these changes is to help ensure that sunscreen testing is conducted and documented in a way that verifiably provides for protection of human subjects and increases the reliability of the testing data that underlies sunscreen labeling, and to update the labeling requirements. (ii) Test subsite. (A) The solar simulator must have the following percentage of erythema-effective radiation in each specified range of wavelengths: Table 2 to Paragraph (i)(2)(i)(A)—Solar Simulator Emission Spectrum. on FederalRegister.gov These volatile solvents are necessary to the formulation to allow the product to be sprayed onto the skin. 791-796, 1997. Krause, M., A. Klit, M. Blomberg Jensen, et al., “Sunscreens: Are They Beneficial for Health? Dermal carcinogenicity data are available from the National Toxicology Program for trolamine in acetone and trolamine alone (applied neat). The labeling of the product contains the statement in § 201.327(f) of this chapter under the heading “Other information.”. We request comment on this assumption. b. 439, pp. With these, the bruise heals fast while one gets rid of the pain as well. * 181. These characteristics include: (1) Containing the ingredients we propose to classify as categories II and III (see sections VIII.B-C); (2) being labeled, represented, or promoted for use as a combined sunscreen-insect repellant (see section IX.E); (3) failing to comply with provisions relating to maximum SPF values and broad spectrum requirements (see section IX.B); and (4) failing to conform to certain other sunscreen formulation and dosage form conditions (see sections IX.A and D). Based on marketing data submitted to the ANPR docket and in a related citizen petition (Docket No. (iv) Records of sunscreen product application, including: (A) A record of all sample weights, including analytical balance; and. In 2007 (72 FR 49070 at 49085 to 49087) and then in 2011 (Max SPF PR), we tentatively concluded that data existed to show that sunscreens with labeled SPF values of up to 50+ provide additional clinical benefit to consumers. Found inside – Page 46... an eye bath and eye wash bottle ; ready - to - use antiseptic solution and cream ; simple over - the - counter medicines such as aspirin and antacids ; and a booklet or leaflet giving advice on first - aid treatment . Pesticides that are or have been used in combination products that also contain sunscreens include DEET, IR3535, and oil of citronella. Sunscreen products must be labeled with an SPF value calculated using a standardized SPF testing procedure set forth in FDA regulations (in § 201.327(i)). As indicated above, FDA also does not propose to categorically classify sunscreen products that are manufactured using nanotechnology or contain nanomaterials as GRASE or not, solely on that basis. A number of changes in § 201.327(i)(1) are being proposed to ensure adequate monitoring of clinical final formulation testing. 58-67, 2011. Part B, Developmental and Reproductive Toxicology, vol. Raju, and E.M. Warshaw, “Adverse Reactions to Sunscreen Agents: Epidemiology, Responsible Irritants and Allergens, Clinical Characteristics, and Management,” Dermatitis, vol. 383-389, 2009. FDA, “Nonprescription Drug Advisory Committee, September 4-5, 2014, Meeting Minutes” (available at https://wayback.archive-it.org/​7993/​20170404152726/​https://www.fda.gov/​downloads/​AdvisoryCommittees/​CommitteesMeetingMaterials/​Drugs/​NonprescriptionDrugsAdvisoryCommittee/​UCM421304.pdf), accessed March 27, 2018. Although insect repellents and sunscreens are designed to exert their Start Printed Page 6248protective effects on the surface of the skin, the studies described above suggest that combining a sunscreen and insect repellent in a single product may result in unintended systemic exposure to the sunscreen ingredient oxybenzone and the insect repellent ingredient DEET. In addition, the entire statement would appear in the same font style, size, and color with the same background color, and as continuous text with no intervening text or graphic. FDA estimates 1.943 responses per respondent for a total of 1,500 responses. 152. Found inside – Page 301Since July 1994 she had been combating constipation by improper use of an iodine-containing antiseptic cream for ... in this patient was probably triggered by improper long-term use of an over-the-counter iodinecontaining cream. (vii) Investigator reports—(A) Safety reports. FDA's general labeling regulations for OTC drugs provide for OTC monographs to require flammability labeling in suitable cases (§ 201.66(c)(5)(ii)(C)) (21 CFR 201.66(c)(5)(ii)(C))), and we have done so for products such as topical antitussives (21 CFR 341.74) and wart removers (21 CFR 358.150). Explore Mobility Products . This improved fidelity across the UV spectrum is especially important for high SPF products which, as discussed above, are associated with longer intentional sun exposure, which in turn can result in significant doses of UVA radiation. After publication of the final sunscreen monograph in 1999, FDA published its TEA regulation (§ 330.14), (67 FR 3060 at 3074, January 23, 2002), which sets forth criteria and procedures by which OTC drugs initially marketed in the United States after the OTC Drug Review began and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system. It is found in antibacterial soaps, wound-cleansing applications, and household antiseptics. Diffey, “The Effect of Applied Thickness on Sunscreen Protection: In Vitro and In Vivo Studies,” Photochemistry and Photobiology, vol. Use of oxybenzone in sunscreens increased when “PABA-free” sunscreens were introduced into the market because of recognition that PABA and its esters induced contact and photocontact allergic reactions (Ref. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: [bullet] limit time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses”. In section VIII, we discuss our review of the scientific literature, submissions to the sunscreen monograph docket, and adverse event reports submitted to FDA's Adverse Event Reporting System (FAERS) for the ingredients listed in the Stayed 1999 Final Monograph and identify any existing gaps. 187). Most people develop an immune response that causes warts to go away by themselves. 82, 115, and 116). Additionally, we propose to consolidate under new § 310.549 (21 CFR 310.549) certain properties that render an OTC drug product offered for use as sunscreen a new drug for which an approved NDA is required prior to marketing. However, if FDA were to receive sufficient data to support a positive GRASE finding for avobenzone up to 5 percent, we would expect to include Start Printed Page 6228avobenzone at this percentage in a final sunscreen monograph. Ha, et al., “Exome Sequencing Identifies Recurrent Somatic Rac1 Mutations in Melanoma,” Nature Genetics, vol. The following sections describe the specific safety data that FDA expects the Agency will need to determine whether an active ingredient is GRASE for use in sunscreens. 4). 71(2), pp. * 8. Avobenzone, like oxybenzone, is an organic (chemical) UV filter. We found neither in the existing record. Dermatologists recommend this at-home therapy for people who have eczema and other skin rashes. Consumers would also experience transaction cost savings. 16. 119). provide legal notice to the public or judicial notice to the courts. Other diffusion tests using pigskin or artificial membranes and various combinations of DEET and oxybenzone in different media suggested an enhancing effect on dermal penetration of both DEET and oxybenzone (Refs. Young, et al., “Non-Melanoma Skin Cancer: Ten Years of Cancer-Registry-Based Surveillance,” International Journal of Cancer, vol. We expect that persons responsible for conducting final formulation testing should already be following best practices in their current testing programs. Accordingly, a MUsT and toxicokinetic data are needed to determine the relevance of these findings to human use of oxybenzone as a sunscreen active ingredient. 39-43, 2006 (available at http://eur-lex.europa.eu/​legal-content/​EN/​TXT/​PDF/​?uri=​CELEX:32006H0647&​from=​EN), accessed March 27, 2018. (2) SPF testing records. If the calculated safety margin for an active ingredient (based on nonclinical results and human MUsT) is relatively small, FDA will exercise its scientific judgment to determine whether a sunscreen active ingredient MUsT in young children or other studies are warranted to ensure that the safety margin for marketed products containing the ingredient is within an acceptable range for this population. 69. 99-104, 2001. Failure of an entity to comply with provisions of this part governing responsibilities it has assumed would subject that entity to the same regulatory action as if it were a responsible person who had failed to comply with those obligations. As previously noted, we expect that data from all the types of studies described in section VII will be needed to support general recognition of safety and effectiveness for these ingredients. This will occur one time per study, with each of the 20 investigators conducting multiple studies per year. In addition to the active ingredient safety data already described, FDA's GRASE evaluation also takes into consideration publicly available information about serious adverse drug experiences and known or expected adverse effects associated with commercially marketed products that contain the active ingredient(s) under consideration. (iii) As an option, the labeling may state “[bullet] apply to all skin exposed to the sun”. 46). Their results indicated that the enhanced dermal penetration evidenced in the in vitro studies translated to increased systemic exposure to both oxybenzone and DEET (Refs. Nonetheless, we invite comment (including supporting data) on whether sunscreens containing titanium dioxide are negatively impacted by the potential photocatalytic effects of that ingredient and, if so, to what extent; and on additional regulatory conditions, if any, that are necessary to address this potential issue. Background. 177-195, 2009. Proposed Maximum Sun Protection Factor and Broad Spectrum Requirements, 5. FDA estimates 2 responses per respondent (1 CV and 1 investigator statement) for a total of 40 annual responses. Among other things, the L&E Final Rule established optional broad spectrum labeling, created an optional indication relating to decreasing the risk of skin cancer and early skin aging for broad spectrum products with an SPF of 15 or higher, and required a labeling warning for sunscreens that did not both satisfy the broad spectrum test and provide an SPF of at least 15. Matlack, S., “From Tanning Accessory to Health Necessity: History of the OTC Sunscreen Monograph in Light of the Sunscreen Revolution” (available at https://nrs.harvard.edu/​urn-3:HUL.InstRepos:8965570), accessed March 27, 2018.

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