On December 15, 2021, FDA offered a webinar for OTC Sunscreen and discussed Deemed Final Order(DFO) for OTC sunscreen drugs.
(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
Previously Proposed Order
Any of 16 active ingredients are considered as GRASE
Only (n) & (p) are GRASE
Other 14 Ingredients are NOT GRASE
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
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.
-oils, lotions, creams, gels, butters,
pastes, ointments, and sticks
-sprays (subject to particle size restrictions etc..)
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
• Clarifies that required records would be subject to
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
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
• 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