chapter  7
22 Pages

The Final Monograph

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.