Guidance for Industry
Drug Products Containing Ensulizole,
Hypromellose, Meradimate,
Octinoxate, and Octisalate 
Labeling Enforcement Policy
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
May 2003
Procedural Guidance for Industry
Drug Products Containing Ensulizole,
Hypromellose, Meradimate,
Octinoxate, and Octisalate 
Labeling Enforcement Policy
Additional copies are available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch (HFD-210)
5600 Fishers Lane
Rockville, MD  20857
(Tel) 301-827-4573
(Internet)  http://www.fda.gov/cder/guidance/index/htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
May 2003
Procedural TABLE OF CONTENTS
I. INTRODUCTION.................................................................................................................1
II. BACKGROUND...................................................................................................................1
A. USP Monograph Title Changes....................................................................................................1
B.  Established Names.........................................................................................................................2
C. Citizen Petitions.............................................................................................................................2
III.  EXERCISE OF ENFORCEMENT DISCRETION...........................................................3 1
Guidance for Industry
Drug Products Containing Ensulizole, Hypromellose,
Meradimate, Octinoxate, and Octisalate  Labeling
Enforcement Policy
This guidance represents the Food and Drug Administration's (FDA's) current thinking on
this topic.  It does not create or confer any rights for or on any person and does not operate
to bind FDA or the public.  You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot
identify the appropriate FDA staff, call the appropriate number listed on the title page of
this guidance.
I.  INTRODUCTION
This guidance discusses how FDA plans to exercise its enforcement discretion after September 1,
2002, with regard to drug products whose labeling does not use the established names for
ensulizole, hypromellose, meradimate, octinoxate, and octisalate. 
II.  BACKGROUND
A series of actions related to the need for labeling changes for certain drug products has led to
the development of this guidance.  The actions are outlined briefly here.
A. USP Monograph Title Changes
In the May and June 2000 Pharmacopeial Forum, Volume 26, No. 3, the United States
Pharmacopeial Convention proposed changes to several United States Pharmacopeia (USP)
monographs.  These title changes, which shortened the names of certain substances, were made
to harmonize USP usage with World Health Organization (WHO) and, in some cases, European
Pharmacopoeia usage.  These changes were finalized on January 2, 2001, in the 3rd USP 24-NF
19 Supplement.  The Supplement generally went into effect March 1, 2001.  However, the
                                                
1 This guidance has been prepared by the Office of Regulatory Policy in the Center for Drug Evaluation and
Research (CDER) at the Food and Drug Administration.
1 monograph title changes discussed in this guidance were given a delayed effective date of
September 1, 2002.  The following title changes were made:
  hydroxypropyl methylcellulose to hypromellose
  menthyl anthranilate to meradimate
  octyl methoxycinnate to octinoxate
  octyl salicylate to octisalate
  phenylbenzimidazole sulfonic acid to ensulizole 
Ensulizole, meradimate, octinoxate, and octisalate are active ingredients used in sunscreen drug
products for over-the-counter (OTC) human use.  Hypromellose is a widely used inactive
ingredient and is used to a lesser extent as an active ingredient in pharmaceutical products.
B.  Established Names
Section 502(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C.
352(e)(1)(A)) generally requires the label of a drug product to bear the established name of the
drug products active and inactive ingredients.  Section 502(e)(3) (21 U.S.C. 352(e)(3)) defines
the established name as: 
(A) the applicable official name designated pursuant to section 508 [of the Act],
or (B) if there is no such name and such drug, or such ingredient, is an article
recognized in an official compendium, then the official title thereof in such
compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph
applies, then the common or usual name, if any, of such drug or of such ingredient
* * *.  
The USP is one of the official compendia recognized in the Act (section 201(j), 21 U.S.C.
321(j)).  
Section 508 of the Act (21 U.S.C. 358) authorizes us to designate an official name for any drug if
we determine "that such action is necessary or desirable in the interest of usefulness and
simplicity.''  We do not, however, routinely designate official names for drug products under
section 508 of the Act.  In the absence of designation by FDA of an official name, the current
compendial name will ordinarily be used as the established name (or if there is no compendial
name, the common and usual name would be considered to be the established name).  See 21
CFR 299.4(e).  Because we have not designated official names for these substances, their
compendial names (i.e., ensulizole, hypromellose, meradimate, octinoxate, and octisalate) would
be the established names of the substances.
C. Citizen Petitions
On July 26, 2002, the Cosmetic, Toiletry, and Fragrance Association (CTFA) submitted a
petition requesting that we publish a rule amending  352.10 and 352.20 to provide a
September 1, 2003, effective date for the active ingredient name changes to ensulizole,
2 meradimate, octinoxate, and octisalate.2  As an alternative, the CTFA requested that we provide
notice to industry that we will exercise enforcement discretion and not enforce the requirement
that labeling of drug products subject to the OTC sunscreen monograph bear the new names until
September 1, 2003. 
On August 2, 2002, Bayer Health Care, Consumer Health Division also submitted a petition
essentially requesting us to stay, until September 1, 2003, any enforcement action based on a
manufacturers or distributors failure to bring its products labeling into compliance with the
USP monograph title change from hydroxypropyl methylcellulose to hypromellose.3
III.  EXERCISE OF ENFORCEMENT DISCRETION
As we discuss in further detail in our response to CTFA's petition, we determined that industry
could have experienced uncertainty regarding our timing for implementation of the USP name
changes for sunscreen products.  In addition, we have determined that exercising our
enforcement discretion regarding all of the labeling changes discussed in this guidance is
appropriate to avoid the need for drug manufacturers and distributors to incur extraordinary
expenses in implementing the labeling changes immediately or to cease marketing certain drug
products whose labeling cannot be changed in a timely manner.  As the petitioners state, these
ingredients are found in numerous sunscreen and other pharmaceutical products. 
While harmonization of drug names with WHO and the European Pharmacopoeia is an
important goal of both USP and FDA, this limited use of enforcement discretion should not lead
to any significant confusion.  Most pharmacists or other individuals who are knowledgeable
about inactive ingredients or active ingredients in sunscreen and ophthalmic products are familiar
with the names hydroxypropyl methylcellulose, menthyl anthranilate, octyl methoxycinnate, octyl
salicylate, and phenylbenzimidazole sulfonic acid.  These names have been used for years, and
the continued use of the names for one more year should not cause any significant problems.
Accordingly, we intend to exercise our enforcement discretion by not initiating any enforcement
action based on a firms failure to bring its products labeling into compliance, before September
1, 2003, with the USP monograph title changes for ensulizole, hypromellose, meradimate,
octinoxate, and octisalate. 
We note, however, that the USP is currently considering a large number of similar changes.
Manufacturers and distributors are responsible for keeping up to date on these changes and any
other changes being considered for, or made to, the USP.  The USP-NF and the Pharmacopeial
Forum are available by purchase or subscription.  The changes will be first proposed in the
Pharmacopeial Forum.  Interested parties have opportunities to comment on proposed changes
and request appropriate effective dates. While we intend to exercise our enforcement
discretion in relation to the established names discussed in this guidance, manufacturers should
                                                
2 See docket number 78N-0038/PSA3.
3 See docket number 02P-0357/PSA1.
3 not assume we will exercise such discretion in the future with respect to other established name
changes.  
4