SPF Labeling and Testing Requirements for OTC Sunscreen Products

ICR 201902-0910-001

OMB: 0910-0717

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0717 201902-0910-001
Active 201507-0910-010
SPF Labeling and Testing Requirements for OTC Sunscreen Products
Extension without change of a currently approved collection   No
Approved without change 03/21/2019
Retrieve Notice of Action (NOA) 02/28/2019
If related regulatory changes are finalized, this ICR will need to be revised accordingly (in time for a final rule's effective date).
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved 03/31/2019
183 0 183
1,689 0 1,689
0 0 0

This ICR pertains to testing and labeling requirements for OTC sunscreen products marketed containing specified active ingredients and marketed without an approved new drug application or abbreviated new drug application. OTC sunscreen products are required to be tested according to the SPF test procedure in 21 CFR 201.327(i). OTC sunscreen product must be labeled with its SPF value on its principal display panel according to labeling requirements in 21 CFR 201.327(a)(1). The requirement to label OTC sunscreen products with an SPF value determined by the SPF test results in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreen products. Compliance with the drug facts label requirement at 21 CFR 201.66 results in an additional third-party disclosure burden for these manufacturers.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act (FD&C Act)

Not associated with rulemaking

  83 FR 42509 08/22/2018
84 FR 2878 02/08/2019

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 183 183 0 0 0 0
Annual Time Burden (Hours) 1,689 1,689 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Domini Bean 301 796-5733 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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