G/TBT/N/USA/1443/Add.2  
 
28 September 2021  
(21-7223) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  28 September 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Sunscreen Drug Products for Over-the-Counter Human Use  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[  ] Interpretive guidance issued and text available from1:  
[X] Other: https://www.govinfo.gov/content/pkg/FR -2021-09-27/html/2021 -20780.htm  
https://www.govinfo.gov/content/pkg/FR -2021-09-27/pdf/2021 -20780.pdf  
https://members.wto .org/crnattachments/2021/TBT/USA/21_6166_00_e.pdf  
 
Description:  TITLE: Amending Over -the-Counter Monograph M020: Sunscreen Drug Products for 
Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability  
AGENCY: Food and Drug Administration, HHS  
ACTION: Notice of availability  
SUMMARY: The Food and  Drug Administration (FDA, Agency, or we) is announcing the availability 
of an over -the-counter (OTC) monograph proposed order (order ID OTC000008) entitled "Amending 
Over-the- Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use." FDA i s 
issuing this proposed order to amend and revise the deemed final administrative order concerning 
nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the 
Coronavirus Aid, Relief, and Economic Security Act (CARES Ac t). This proposed order, if finalized, 
would replace the Deemed Final Order in its entirety with new conditions under which nonprescription 
sunscreen drug products would be determined to be generally recognized as safe and effective 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1443/Add.2  
 
- 2 - 
 
  (GRASE) under the Feder al Food, Drug, and Cosmetic Act (FD&C Act). It also sets forth certain 
characteristics that would establish that a sunscreen drug product is not GRASE.  
DATES: Submit electronic comments on the proposed order by 11:59 p.m. Eastern Time at the end 
of 12 Nove mber 2021.  
This notice of availability and previous actions notified under the symbol G/TBT/N/USA/1443  are 
identified by Docket Number FDA -1978-N-0018. The Docket Folder is available on Regulations.gov 
at https://www.regulations.gov/docket/FDA -1978-N-0018/document  and provides access to 
primary and supporting documents as well as comments received. Documents are also accessible 
from Regulations.gov  by searching the Docket Number. WTO Members and their stakeholders are 
asked to submit comments to the USA TBT Enquiry Point . Comments received by the USA TBT 
Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will 
also be submitted to the Docket  on Regulations.gov if received within the comment period.  
__________