ABSTRACT
Introduction 354
Formula Types 356
Emulsions 356
Oils 358
Gels 359
Sticks 361
Mousses 361
Aerosols 362
Ointments 362
Formulating Basics 362
Principles of Emulsification 362
Selecting Key Ingredients 365
Emulsifiers 365
Emollients 367
Film Formers 368
Stabilizers/Protectants 369 Organic Sunscreens 370
Inorganic/Particulate Sunscreens 372 Fragrances 373
Achieving Formula Goals 373
To Achieve High SPFs 373
To Achieve Water Resistance 374
To Obtain Mild Formulations 374
Patent Issues 375
Stability Evaluation 375
Organoleptic Considerations 376
The Use of Antioxidants in Sunscreen Formulations 376
Formulations 376
References 382
INTRODUCTION
With the publication of the Final Sunscreen Monograph on May 21, 1999, the
“playing field” for marketers of finish goods became more complex and now
offered some new opportunities for “marketing handles.” Although some
claims could no longer be made, such as those relating to aging and wrinkling,
we now see the appearance of strong claims dealing with ultraviolet-A (UV-A)
radiation. In fact, the US Food and Drug Administration (FDA) has even pub-
lished a list of those sunscreens for which usage permits UV-A reference.
Some additional claims have begun to appear deal with protection against infra-
red (IR) radiation. The FDA Tentative Final Monograph (TFM) does not deal with
IR in any way. Thus, IR claims are cosmetic and not drug claims. They must
be substantiated for the Federal Trade Commission (FTC), but not the FDA.
Marketersalso have made claims for “all-day” waterproof protection. The FDA
no longer allows a waterproof claim. They feel that the term suggests an
absolute-waterproof-which is not borne out by the currently available test
methods. The sweat proof claim can now be made, if the product meets the
requirements for a very water-resistant claim. Additionally, extended claims
such as “all day” are not permitted.
