• Provision Consulting Group

FDA Webinar, OTC Sunscreen Deemed Final Order (DFO)


On December 15, 2021, FDA offered a webinar for OTC Sunscreen and discussed Deemed Final Order(DFO) for OTC sunscreen drugs.





Active Ingredients


(a) Aminobenzoic acid (PABA) up to 15 percent.

(b) Avobenzone up to 3 percent.

(c) Cinoxate up to 3 percent.

(d) Dioxybenzone up to 3 percent.

(e) Ensulizole2 up to 4 percent.

(f) Homosalate up to 15 percent.

(g) Meradimate3 up to 5 percent.

(h) Octinoxate4 up to 7.5 percent.

(i) Octisalate5 up to 5 percent.

(j) Octocrylene up to 10 percent.

(k) Oxybenzone up to 6 percent.

(l) Padimate O up to 8 percent.

(m) Sulisobenzone up to 10 percent.

(n) Titanium dioxide up to 25 percent.

(o) Trolamine salicylate up to 12 percent.

(p) Zinc oxide up to 25 percent.


* DFO considers the above 16 active ingredients to be GRASE.


Differences between DFO and previously proposed order

DFO

Previously Proposed Order

Active Ingredients

Any of 16 active ingredients are considered as GRASE

Only (n) & (p) are GRASE

Other 14 Ingredients are NOT GRASE


Maximum SPF

No limit on maximum SPF values

Maximum SPF = SPF 60+

(permits the marketing of sunscreen products formulated with SPF values up to 80)


Broad Spectrum Requirement

Not Required. But it is necessary for the broad spectrum labeling claim

All sunscreens with SPF values of

15 and above must satisfy broad

spectrum requirements, including

a proposed new requirement that

broad spectrum products meet a

UVA I / UV ratio of 0.7 or higher


Dosage Forms

section 505G(m)(2)


All dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder can only be marketed with an NDA or ANDA.


GRASE

-oils, lotions, creams, gels, butters,

pastes, ointments, and sticks

-sprays (subject to particle size restrictions etc..)


NOT GRASE

-powders


​Principal Display Panel (PDP) Labeling

Same labeling requirements that have been in effect for sunscreen products since 2011

Revised Statement of Identity (SOI)

- Alphabetical listing of active ingredients followed by “Sunscreen” and the product’s dosage form

Sunscreens with an SPF below 15 required to include the SPF statement on PDP followed by an asterisk(*) to a statement directing consumers to see the “SkinCancer/Skin Aging alert” in the Drug Facts label (DFL)

Font and placement changes to ensure SPF, broad spectrum, and water resistance statements stand out


Final formulation testing and recordkeeping

Does not address record keeping

Records of required final formulation testing of

sunscreen products be maintained for 1 year after

the product expiration date, or, if the product is

exempt from expiration dating (as most sunscreens

are), for 3 years after distribution of the last lot

labeled in reliance on that testing

• Responsible persons keep records of sunscreen

formulation testing

• Clarifies that required records would be subject to

FDA inspection


Sunscreen-insect repellent combinations

Does not address sunscreen-insect repellent combinations

These products are not GRASE because incompatibilities between FDA and EPA

labeling requirements prevent these products from being labeled in a manner

that sufficiently ensures safe and effective

use of the sunscreen component and provides adequate directions for use


Other Information


Proposed order does not represent a conclusion by FDA that the 12 sunscreen active ingredients (Other than (n)&(p)) proposed as needing additional data are unsafe for use in OTC sunscreen drugs


FDA requested additional information on these active ingredients so that we can evaluate their GRASE status considering changed conditions of use such as:


– substantially increased sunscreen drug usage and exposure to sunscreens by consumers

– evolving information about their potential risks



Resources


• Deemed Final Order for OTC Sunscreens - Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use


• Proposed Order for OTC Sunscreens - Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use


• OTC Monographs@FDA - https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm


• FDA’s OTC Drug Review | OTC Monograph Reform in the CARES Act website https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otcmonograph-reform-cares-act


• Additional Webinars on OTC Monograph Reform – For Topic, select ‘OTC Drug Regulation’ https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-andindustry-assistance-sbia-learn