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The SPF of any combination product is measured by the testing
procedures established in subpart D of this part.
(a) Combinations of sunscreen active ingredients. (1) Two
or more sunscreen active ingredients identified in § 352.10(a),
(c), (e), (f), and (h) through (r) may be combined with each other
in a single product when used in the concentrations established for
each ingredient in § 352.10. The concentration of each active
ingredient must be sufficient to contribute a minimum SPF of not
less than 2 to the finished product. The finished product must have
a minimum SPF of not less than the number of sunscreen active
ingredients used in the combination multiplied by 2.
(2) Two or more sunscreen active ingredients identified in §
352.10(b), (c), (e), (f), (i) through (l), (o), and (q) may be
combined with each other in a single product when used in the
concentrations established for each ingredient in § 352.10. The
concentration of each active ingredient must be sufficient to
contribute a minimum SPF of not less than 2 to the finished
product. The finished product must have a minimum SPF of not less
than the number of sunscreen active ingredients used in the
combination multiplied by 2.
(b) Combinations of sunscreen and skin protectant active
ingredients. Any single sunscreen active ingredient or any
permitted combination of sunscreen active ingredients when used in
the concentrations established for each ingredient in § 352.10 may
be combined with one or more skin protectant active ingredients
identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m),
and (r) of this chapter. The concentration of each sunscreen active
ingredient must be sufficient to contribute a minimum SPF of not
less that 2 to the finished product. The finished product must have
a minimum SPF of not less than the number of sunscreen active
ingredients used in the combination multiplied by 2, and the
product must be labeled according to § 352.60.
(c) [Reserved]
[64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4,
2003] Effective Date Note:At 67 FR 41823, June 20, 2002, § 352.20
was amended by revising paragraphs (a)(1) through (a)(2), effective
Sept. 1, 2002. This amendment could not be incorporated because at
66 FR 67485, Dec. 31, 2001 the effective date was stayed until
further notice. For the convenience of the user, the text is set
forth as follows: § 352.20 Permitted combinations of active
ingredients.
(a) Combinations of sunscreen active ingredients. (1) Two
or more sunscreen active ingredients identified in § 352.10(a),
(c), (e), (f), (g), and (i) through (r) may be combined with each
other in a single product when used in the concentrations
established for each ingredient in § 352.10. The concentration of
each active ingredient must be sufficient to contribute a minimum
SPF of not less than 2 to the finished product. The finished
product must have a minimum SPF of not less than the number of
sunscreen active ingredients used in the combination multiplied by
2.
(2) Two or more sunscreen active ingredients identified in §
352.10(b), (c), (e), (g), (j) through (m), (o), and (q) may be
combined with each other in a single product when used in the
concentrations established for each ingredient in § 352.10. The
concentration of each active ingredient must be sufficient to
contribute a minimum SPF of not less than 2 to the finished
product. The finished product must have a minimum SPF of not less
than the number of sunscreen active ingredients used in the
combination multiplied by 2.
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