The final rule for over the counter (OTC) sunscreen products has been
delayed. Once the proposed legislation is in place, these products will be
subject to the requirements in 21 CFR 352, which was published in May 1999. It
should be noted that the requirements for effectiveness and labeling will
continue to be in 21 CFR 201.327.
The delay has been caused, in part, by Senate Bill 2740 having passed
through the first House of Congress. Among other requirements, this bill requires
the Secretary of Health and Human Services to:
- Amend and revise the administrative order surrounding OTC sunscreen products
- Issue a revised sunscreen order (within 18 months of the proposed OTC Reform Act’s enactment and effective one year later)
The revised proposal must include provisions relating to the
effectiveness of SPF levels and consider dosage forms. If it does not, there
must be a rationale for exclusion and a new plan and timeline.
Unless included in the Secretary of Health and Human Services’ proposal,
the provisions of this Act will delay and/or invalidate the provisions set
forth by the FDA Proposed Rule. This includes any new criteria for UVA
determination, updated labelling requirements, and other provisions surrounding
sunscreen efficacy testing. The bill is now with the House Committee on Energy
During this delay, the 2011 sunscreen final rule, outlined in 21 CFR
201.327(i), will continue to govern labeling and effectiveness. Therefore, the
current claim substantiation process is still in place for Broad Spectrum and
SPF claims when marketing sunscreens. Broad Spectrum claims are currently only
required when the product is marketed as having Broad Spectrum protection and is
only permitted if the product has total absorbance of at least 90% by 370 nm.
The current situation also allows the continued use of OTC sunscreen
products containing twelve ingredients initially left
without a GRASE determination in the current proposed rulemaking. These
include oxybenzone and octinoxate – two UV filters that have been much
scrutinized in recent years because they allegedly bleach and degrade coral.
Stakeholder should be aware that, while these ingredients may currently
still be marketed, individual jurisdictions, such as Hawaii, Florida and the US
Virgin Islands, do ban their use.
Manufacturers and suppliers should also note that a new bill – H.R. 4296
Safe Cosmetics and Personal Care Products Act of 2019 – exists that would
require ingredients to be reviewed and placed in one of the following
- Prohibited and restricted ingredients
- Ingredients safe without limits
- An insufficient data list
Twelve ingredients are included in the bill’s prohibited list, including
oxybenzone and octinoxate.
While there has been a delay, there is general bipartisan support for
the proposed bills, and once they are accepted there will be significant regulatory
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