ABSTRACT
History and Scope of the Regulation 96
Key Provisions of the Final Monograph 101
Permitted Active Sunscreen Ingredients 101
Ingredients Listed in 21 CFR 352.10 101
Active Ingredient Combinations 102
Sunscreen Active Ingredient Combination Pattern A 102
Sunscreen Active Ingredient Combination Pattern B 103
Ingredients for Combination Sunscreen-Skin Protectant Products 103
Combinations of Sunscreens and Skin Protectant Ingredients 103
Labeling Requirements 104
On the Principal Display Panel 105
In the Drug Facts Panel 106
Labeling Caveats 108
Antiaging/Antiphotoaging 109 Tanning Accelerators, Melanin and Antioxidants 109
Warnings for Tanning Products without Sunscreens 109
“Chemical-free”, “Natural”, and “PABA-free” Ingredients 110
Extended Protection Claims 110
Freckles and Uneven Skin Tone 110
Testing Sunscreen Efficacy 111
What of the Future? 111
FDA Requests for Information and Comment 112
Conclusion 114
HISTORY AND SCOPE OF THE REGULATION
The US Food and Drug Administration (FDA) published the Final Rule for
Sunscreen Drug Products for Over-the-Counter Human Use on May 21, 1999,1
and the resulting regulation (or monograph) is codified in 21 Code of Federal
Regulations (CFR), Parts 352.1-352.77, 310.545, 700.35, and 740.19. The
Rule establishes the conditions under which a sunscreen is “generally recognized
as safe and effective” and not misbranded for its intended use by identifying the
authorized monograph sunscreen active ingredients, their permitted combi-
nations, and any limitations on their use; establishes the required label statements
and format for all sunscreen drug products; and sets forth the official test method to
determine sun protection factor (SPF) values and performance claims such as
“water resistant/very water resistant”. A major regulatory advantage of compliance with the Final Rule is that sunscreen products formulated and labeled in
accordance with the Final Rule and that also comply with other general require-
ments for over the counter (OTC) drug products and facilities2 may be placed
on the US market without further FDA review and are not subject to new drug
approval procedures.
