HOT TOPICSSouthwest Society of Cosmetic ChemistryAugust 2019

AGENDA• History of

Sunscreen Regulation in United States

• Review the Science

• Recap the Summer of 2019

1978The journey begins with US FDA Advance Notice of Proposed Rulemaking

This proposed rule would establish conditions for the safety, effectiveness, and labeling of over-the-counter (OTC) sunscreen drug products.

• FDA Panel review of sunscreen ingredients

• Notes the harmful effects of sunlight on skin:• Skin Cancer• Premature Aging

1988US FDA approves avobenzone, a UVA-filter

1997US FDA allows sunscreen makers to market to UVA protection

2006US FDA misses the Congressional deadline to approve proposed guidelines for sunscreens

2011Final Rule for labeling and effectiveness testing

2019Tentative Final Monograph

The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).

KEY SECTIONS:1. Need for Additional Safety

Information2. Framework for Evaluation of

Safety Data3. Existing Safety Data for

Sunscreen Active Ingredients4. Additional Proposed

Conditions of Use5. Comment Period6. Proposed Effective/Compliance

Dates

SAFETY• In Section VI: Need for Safety

Information, FDA expresses two concerns:

• Increased Consumer Exposure to Sunscreen Active Ingredients

• Emerging Safety Concerns

• reapply• after 40 minutes of

swimming or sweating• at least every 2 hours

SAFETYGRASE• Zinc Oxide• Titanium Dioxide

Not GRASE• PABA• Trolamine salicylate

Insufficient Data• 12 ingredients

Category 1

Category 2

Category 3

1. Cinoxate2. Dioxybenzone3. Ensulizole4. Homosalate5. Meradimate6. Octinoxate7. Octisalate8. Octocrylene9. Padimate O10.Sulisobenzone11.Oxybenzone12.Avobenzone

THE ENVIRONMENTBans on Oxybenzone & Octinoxate:

HawaiiKey West, FL

Palau (Pacific)Aruba & Bonaire (Caribbean)

Themes within the sunscreen bans:• Effective Jan 1, 2021 (-ish)• Beach product only, or• Promote “reef safe” sunscreens

THE ENVIRONMENT – NEW SCIENCE

STUDY DESIGN: Cultured adult coral exposed to 5 UV filters and 2 parabens for 5 weeksRESULTS: No adverse effects (lethal or sublethal) up to water solubility limit were observed

THE ENVIRONMENT – NEW SCIENCE

STUDY DESIGN: Evaluated 13 UV filters in seawater, sediment and coral tissue at 19 sites around Oahu, HIRESULTS: Provide information for further risk assessment. EX: aqueous BP-3 concentrations below reported toxicity thresholds

SUMMER OF 2019

Comments due to FDAReceived 1,001 comments

• NGOs• Industry Associations• Health Professionals• Private Citizens

SUMMER OF 2019

Deferral Request to FDAPCPC & CHPA requested a deferral to rulemaking on 8 Category 3 UV filters

1. Ensulizole2. Homosalate3. Meradimate4. Octinoxate5. Octisalate6. Octocrylene7. Oxybenzone8. Avobenzone

Not included:1. Cinoxate2. Dioxybenzone3. Padimate O4. Sulisobenzone

SUMMER OF 2019

US VIRGIN ISLANDS• Oxybenzone• Octinoxate• Octocrylene

Dec 31, 2019 – Import banSept 30, 2020 – Marketing banJan 1, 2021 – Ban on possession and use

AGENDAQUESTIONS• History of

Sunscreen Regulation in United States

• Review the Science

• Recap the Summer of 2019