Current Sunscreen Regulations

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Current Sunscreen Regulations

• Michael L. Koenig, Ph.D.
• May 21, 2007

Office of Nonprescription Products
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(No Transcript)
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Outline

• Regulation Development
• Whats in the sunscreen regulations?
• What about UVA regulations?
• Where can I find the regulations?
• Questions

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Regulation Development

• Category I GRASE
• Category II not GRASE
• Category III cannot determine if safe and
  effective

• Monograph/GRASE (Cat. I)
• Non-monograph (Cat. II and III)

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Regulation Development

• Monograph/GRASE
• Non-monograph

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Regulation Development
Public feedback
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Regulation Development
Public feedback
Information
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Regulation Development OTC Sunscreens
2010
1970
2000
1980
1990
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Whats in the Sunscreen Regulations?

• GRASE active ingredients
• Dosage strengths (Maximum)
• Combinations
• Labeling requirements
• Principal Display Panel (PDP)
• Drug Facts
• SPF Testing procedures

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Active Ingredients

• Aminobenzoic acid (PABA), to 15
• Avobenzone, to 3
• Cinoxate, to 3
• Dioxybenzone, to 3
• Ensulizole, to 4
• Homosalate, to 15
• Meradimate, to 5
• Octinoxate, to 7.5

• Octisalate, to 5
• Octocrylene, to 10
• Oxybenzone, to 6
• Padimate O, to 8
• Sulisobenzone, to 10
• Titanium dioxide, to 25
• Trolamine salicylate, to 12
• Zinc oxide, to 25

No minimum must provide an SPF 2
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GRASE Combinations

• SPF of combination 2 x ( active ingredients)
• Each active ingredient must contribute an SPF 2
  to the SPF of the formulation
• Sunscreens with each other
• Sunscreens with skin protectants

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Labeling - PDP

• Statement of identity Sunscreen (not
  Sunblock)
• SPF
• Specific number 30
• 30 or 30 plus
• Water/Sweat/Perspiration Resistant (not
  Proof)
• 20 min. activity in water
• Very Water/Sweat/Perspiration Resistant
• 40 min. activity in water

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Labeling Drug Facts

• Statement of identity (Purpose) sunscreen
• Indications (Uses)
• Warnings
• Directions
• Optional statements on product performance
• Minimum, moderate, high protection
• Sun alert
• Limiting sun exposure, wearing protective
  clothing, and using sunscreens may reduce the
  risks of skin aging, skin cancer, and other
  harmful effects of the sun

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Sunscreen Drug Facts
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SPF Testing Procedures

• Final Formulation
• Standard sunscreen
• Light source, calibration
• General procedures
• Subjects (, skin type, informed consent)
• Test sites
• Application of test materials
• Calculation of SPF
• Water Resistance

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What About UVA Regulations?

• Labeling
• Broad spectrum
• UVA and UVB protection
• UVA Testing (Clinical)
• Photosensitized subjects (8-MOP, psoralen)
• Unsensitized subjects (PPD)

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Where can I find the regulations?
21 CFR Part 352
http//www.access.gpo.gov/cgi-bin/cfrassemble.cgi?
title200621
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Is there more?
http//www.fda.gov/cder/Offices/OTC/default.htm
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Rulemaking History
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Sunscreen
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FR Citations
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Stay Tuned

• FR currently stayed indefinitely
• - Labeling?
• - Testing?
• 2. PR will be published posted on ONP website
• 3. Comment period
• 4. FR publishes

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Questions?
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More Questions?

• 301-796-2090
• http//www.fda.gov/cder/Offices/OTC/default.htm

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STEREO
Solar TErrestrial RElations Observatory