There are FDA regulations what you can print on a container of a sunscreen (classified as OTC-drugs in the US).
I dout it very much that you could write anywhere in the world on a container of a sunscreen: "
taking 300 mg of ibuprofen will improve the protective factor of this sunscreen".
For more info on FDA regulations please see the FDA's monograph on sunscreen
and the attached files Regulations Worldwide
FDA Proposed UVA testing and labelling (IIIE: Labelling)
FDA Final Monograph
LAbelling of sunscreens (Rule:1998)
§ 352.52 Labeling of sunscreen drug
products.
* * * * *
(b) * * *
(2) * * *
(vii) For products containing the
active ingredient identified in
§ 352.10(v), the following labeling
statements may be used—(A) ‘‘Broad
spectrum sunscreen.’’
(B) ‘‘Provides’’ (select one of the
following: ‘‘UVB and UVA’’ or ‘‘broad
spectrum’’) ‘‘protection.’’
© ‘‘Protects from UVB and UVA’’
(select one of the following: ‘‘rays’’ or
‘‘radiation’’).
(D) (Select one of the following:
‘‘Absorbs,’’ ‘‘Protects,’’ ‘‘Screens,’’ or
‘‘Shields’’) ‘‘within the UVA spectrum.’’
(E) ‘‘Provides protection from the
UVA rays that may contribute to skin
damage and premature aging of the
skin.’’
Dated: October 10, 1998.
Today:
Subpart C—Labeling
§ 352.50 Principal display panel of all
sunscreen drug products.
In addition to the statement of
identity required in § 352.52, the
following labeling statements shall be
prominently placed on the principal
display panel:
(a) For products that do not satisfy the
water resistant or very water resistant
sunscreen product testing procedures in
§ 352.76. (1) For products with SPF
values up to 30. ‘‘SPF (insert tested SPF
value of the product up to 30).’’
(2) For products with SPF values over
30. ‘‘SPF 30’’ (select one of the
following: ‘‘plus’’ or ‘‘+’’). Any
statement accompanying the marketed
product that states a specific SPF value
above 30 or similar language indicating
a person can stay in the sun more than
30 times longer than without sunscreen
will cause the product to be misbranded
under section 502 of the Federal Food,
Drug, and Cosmetic Act (the act).
(b) For products that satisfy the water
resistant sunscreen product testing
procedures in § 352.76. (1) (Select one of
the following: ‘‘Water,’’ ‘‘Water/Sweat,’’
or ‘‘Water/Perspiration’’) ‘‘Resistant.’’
(2) ‘‘SPF (insert SPF value of the
product, as stated in paragraph (a)(1) or
(a)(2) of this section, after it has been
tested using the water resistant
sunscreen product testing procedures in
§ 352.76).’’
© For products that satisfy the very
water resistant sunscreen product
testing procedures in § 352.76. (1)
‘‘Very’’ (select one of the following:
‘‘Water,’’ ‘‘Water/Sweat,’’ or ‘‘Water/
Perspiration’’) ‘‘Resistant.’’
(2) ‘‘SPF (insert SPF value of the
product, as stated in paragraph (a)(1) or
(a)(2) of this section, after it has been
tested using the very water resistant
sunscreen product testing procedures in
§ 352.76).’’
§ 352.52 Labeling of sunscreen drug
products.
(a) Statement of identity. The labeling
of the product contains the established
name of the drug, if any, and identifies
the product as a ‘‘sunscreen.’’
(b) Indications. The labeling of the
product states, under the heading
‘‘Uses,’’ all of the phrases listed in
paragraph (b)(1) of this section that are
applicable to the product and may
contain any of the additional phrases
listed in paragraph (b)(2) of this section,
as appropriate. Other truthful and
nonmisleading statements, describing
only the uses that have been established
and listed in this paragraph (b), may
also be used, as provided in § 330.1©(2)
of this chapter, subject to the provisions
of section 502 of the act relating to
misbranding and the prohibition in
section 301(d) of the act against the
introduction or delivery for introduction
into interstate commerce of unapproved
new drugs in violation of section 505(a)
of the act.
(1) For products containing any
ingredient in § 352.10. (i) ‘‘[bullet]1
helps prevent sunburn [bullet] higher
SPF gives more sunburn protection’’.
(ii) For products that satisfy the water
resistant testing procedures identified in
§ 352.76. ‘‘[bullet] retains SPF after 40
minutes of’’ (select one or more of the
following: ‘‘activity in the water,’’
‘‘sweating,’’ or ‘‘perspiring’’).
(iii) For products that satisfy the very
water resistant testing procedures
identified in § 352.76. ‘‘[bullet] retains
SPF after 80 minutes of’’ (select one or
more of the following: ‘‘activity in the
water,’’ ‘‘sweating,’’ or ‘‘perspiring’’).
(2) Additional indications. In addition
to the indications provided in paragraph
(b)(1) of this section, the following may
be used for products containing any
ingredient in § 352.10:
(i) For products that provide an SPF
of 2 to under 12. Select one or both of
the following: [‘‘[bullet]’’ (select one of
the following: ‘‘provides minimal,’’
‘‘provides minimum,’’ ‘‘minimal,’’ or
‘‘minimum’’) ‘‘protection against’’
(select one of the following: ‘‘sunburn’’
or ‘‘sunburn and tanning’’)], or ‘‘[bullet]
for skin that sunburns minimally’’.
(ii) For products that provide an SPF
of 12 to under 30. Select one or both of
the following: [‘‘[bullet]’’ (select one of
the following: ‘‘provides moderate’’ or
‘‘moderate’’) ‘‘protection against’’ (select
one of the following: ‘‘sunburn’’ or
‘‘sunburn and tanning’’)], or ‘‘[bullet] for
skin that sunburns easily’’.
(iii) For products that provide an SPF
of 30 or above. Select one or both of the
following: [‘‘[bullet]’’ (select one of the
following: ‘‘provides high’’ or ‘‘high’’)
‘‘protection against’’ (select one of the
following: ‘‘sunburn’’ or ‘‘sunburn and
tanning’’)], or ‘‘[bullet] for skin highly
sensitive to sunburn’’.
© Warnings. The labeling of the
product contains the following warnings
under the heading ‘‘Warnings:’’
(1) For products containing any
ingredient in § 352.10. (i) ‘‘When using
this product [bullet] keep out of eyes.
Rinse with water to remove.’’
(ii) ‘‘Stop use and ask a doctor if
[bullet] rash or irritation develops and
lasts’’.
(2) For products containing any
ingredient identified in § 352.10
marketed as a lipstick. The external use
only warning in § 201.66©(5)(i) of this
chapter and the warning in paragraph
©(1)(i) of this section are not required.
(d) Directions. The labeling of the
product contains the following
statements, as appropriate, under the
heading ‘‘Directions.’’ More detailed
directions applicable to a particular
product formulation (e.g., cream, gel,
lotion, oil, spray, etc.) may also be
included.
(1) For products containing any
ingredient in § 352.10. (i) ‘‘[bullet]
apply’’ (select one or more of the
following, as applicable: ‘‘liberally,’’
‘‘generously,’’ ‘‘smoothly,’’ or ‘‘evenly’’)
‘‘(insert appropriate time interval, if a
waiting period is needed) before sun
exposure and as needed’’.
(ii) ‘‘[bullet] children under 6 months
of age: ask a doctor’’.
(2) In addition to the directions
provided in § 352.52(d)(1), the following
may be used for products containing
any ingredient in § 352.10. ‘‘[bullet]
reapply as needed or after towel drying,
swimming, or’’ (select one of the
following: ‘‘sweating’’ or ‘‘perspiring’’).
(3) If the additional directions
provided in § 352.52(d)(2) are used, the
phrase ‘‘and as needed’’ in
§ 352.52(d)(1) is not required.
(4) For products marketed as a
lipstick. The directions in paragraphs
(d)(1) and (d)(2) of this section are not
required.
Federal Register / Vol. 64, No. 98 / Friday, May 21, 1999 / Rules and Regulations 27689
(e) Statement on product
performance—(1) For products
containing any ingredient identified in
§ 352.10, the following PCD labeling
claims may be used under the heading
‘‘Other information’’ or anywhere
outside of the ‘‘Drug Facts’’ box or
enclosure.
(i) For products containing active
ingredient(s) that provide an SPF value
of 2 to under 12. (Select one of the
following: ‘‘minimal’’ or ‘‘minimum’’)
‘‘sun protection product.’’
(ii) For products containing active
ingredient(s) that provide an SPF value
of 12 to under 30. ‘‘moderate sun
protection product.’’
(iii) For products containing active
ingredient(s) that provide an SPF value
of 30 or above. ‘‘high sun protection
product.’’
(2) For products containing any
ingredient identified in § 352.10, the
following labeling statement may be
used under the heading ‘‘Other
information’’ or anywhere outside of the
‘‘Drug Facts’’ box or enclosure. ‘‘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.’’ Any variation of this
statement will cause the product to be
misbranded under section 502 of the
act.
(f) Products labeled for use only on
specific small areas of the face (e.g.,
lips, nose, ears, and/or around eyes)
and that meet the criteria established in
§ 201.66(d)(10) of this chapter. The title,
headings, subheadings, and information
described in § 201.66© of this chapter
shall be printed in accordance with the
following specifications:
(1) The labeling shall meet the
requirements of § 201.66© of this
chapter except that the title, headings,
and information described in
§ 201.66©(1), ©(3), and ©(7) may be
omitted, and the headings, subheadings,
and information described in
§ 201.66©(2), ©(4), ©(5), and ©(6)
may be presented as follows:
(i) The active ingredients
(§ 201.66©(2) of this chapter) shall be
listed in alphabetical order.
(ii) The heading and the indication
required by § 201.66©(4) may be
limited to: ‘‘Use [in bold type] helps
prevent sunburn.’’
(iii) The ‘‘external use only’’ warning
in § 201.66©(5)(i) of this chapter may
be omitted.
(iv) The subheadings in
§ 201.66©(5)(iii) through ©(5)(vii) of
this chapter may be omitted, provided
the information after the heading
‘‘Warnings’’ states: ‘‘Keep out of eyes.’’
and ‘‘Stop use if skin rash occurs.’’
(v) The warning in § 201.66©(5)(x) of
this chapter may be limited to the
following: ‘‘Keep out of reach of
children.’’
(vi) For a lipstick, the warnings ‘‘Keep
out of eyes’’ in § 352.52(f)(1)(iv) and
‘‘Keep out of reach of children’’ in
§ 352.52(f)(1)(v) and the directions in
§ 352.52(d) may be omitted.
(2) The labeling shall be printed in
accordance with the requirements of
§ 201.66(d) of this chapter except that
any requirements related to
§ 201.66©(1), ©(3), and ©(7), and the
horizontal barlines and hairlines
described in § 201.66(d)(8), may be
omitted.
§ 352.60 Labeling of permitted
§ 352.60 Labeling of permitted
combinations of active ingredients.
Statements of identity, indications,
warnings, and directions for use,
respectively, applicable to each
ingredient in the product may be
combined to eliminate duplicative
words or phrases so that the resulting
information is clear and understandable.
(a) Statement of identity. For a
combination drug product that has an
established name, the labeling of the
product states the established name of
the combination drug product, followed
by the statement of identity for each
ingredient in the combination, as
established in the statement of identity
sections of the applicable OTC drug
monographs. For a combination drug
product that does not have an
established name, the labeling of the
product states the statement of identity
for each ingredient in the combination,
as established in the statement of
identity sections of the applicable OTC
drug monographs.
(b) Indications. The labeling of the
product states, under the heading
‘‘Uses,’’ the indication(s) for each
ingredient in the combination as
established in the indications sections
of the applicable OTC drug monographs,
unless otherwise stated in this
paragraph. Other truthful and
nonmisleading statements, describing
only the indications for use that have
been established in the applicable OTC
drug monographs or listed in this
paragraph (b), may also be used, as
provided by § 330.1©(2) of this chapter,
subject to the provisions of section 502
of the Federal Food, Drug, and Cosmetic
Act (the act) relating to misbranding and
the prohibition in section 301(d) of the
act against the introduction or delivery
for introduction into interstate
commerce of unapproved new drugs in
violation of section 505(a) of the act.
(1) In addition, the labeling of the
product may contain any of the ‘‘other
allowable statements’’ that are identified
in the applicable monographs.
(2) For permitted combinations
containing a sunscreen and a skin
protectant identified in § 352.20(b).
© Warnings. The labeling of the
product states, under the heading
‘‘Warnings,’’ the warning(s) for each
ingredient in the combination, as
established in the warnings section of
the applicable OTC drug monographs.
For permitted combinations containing
a sunscreen and a skin protectant
identified in § 352.20(b).
(d) Directions. The labeling of the
product states, under the heading
‘‘Directions,’’ directions that conform to
the directions established for each
ingredient in the directions sections of
the applicable OTC drug monographs,
unless otherwise stated in this
paragraph. When the time intervals or
age limitations for administration of the
individual ingredients differ, the
directions for the combination product
may not contain any dosage that
exceeds those established for any
individual ingredient in the applicable
OTC drug monograph(s), and may not
provide for use by any age group lower
than the highest minimum age limit
established for any individual
ingredient. For permitted combinations
containing a sunscreen and a skin
protectant identified in § 352.20(b).
topical as well as oral ibuprofen are published as having UVA spf function ; are there jurisdictions where it is legal to print on a container of sunscreen:
taking 300 mg of ibuprofen will improve the protective factor of this sunscreen then give a journal reference
also, there are chemicals that produce hypothermia at the cytolevel, is it possible that downregulating dermis metabolism during plus immediately after radiation (like UVA) would reduce harmhttp://www.ncbi.nlm....Pubmed_RVDocSum
Tributyl S,S,S-phosphorotrithioate (DEF) produces profound hypothermia in rats, mice and guinea pigs by inhibition of thermogenesis
the vanilloid (capsaicin) receptor agonist resiniferatoxin induces marked hypothermia in the ferret, rat and mouse. The aim of this study was to further characterise the thermoregulatory effects of resiniferatoxin in the rat in an attempt to understand the mechanism by which resiniferatoxin induces this hypothermic effect.
It is well known that radiation causes more harm to metabolically active (rna from dna transcribing) tissues; reducing the rate of tissue metabolism while sunning might strongly reduce harm
also: I have read that scarring occurs when tissue regrows too rapidly; the "fill it" competes with the "repair it" processes; I have not read anything that says this yet it is possible that a chemical that causes dermal hypothermia could reduce cumulative scarring; thats a fancy way of saying: maintain youthful connective tissue structure
Eva Victoria what do you think
Edited by Eva Victoria, 18 June 2008 - 03:12 PM.
