Sunscreen

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Comments regarding guidance for industry pertaining to sunscreen ingredients requesting inclusion into the OTC sunscreen monograph.

Feb 22, 2016

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process."

Jan 19, 2016

Enclosed herein are comments on "Guidance for Industry; Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request", published as Draft Guidance.

Jan 19, 2016

Enclosed herein are comments on "Guidance for Industry; Nonprescription Sunscreen Drug Products - Content and Format of Data Submissions to Support a GRASE determination Under the Sunscreen Innovation Act."

Jan 19, 2016

We ask that in its review of the Proposed Orders, FDA take our framework into consideration when making its GRASE determinations.

Feb 23, 2015

The following comments address 1) data and information on sunscreen spray dosage forms to confirm their eligibility for inclusion in the final sunscreen monograph and 2) data and information supporting the inclusion of powder sunscreens in the final monograph.

Oct 17, 2011

We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.

Sep 15, 2011

Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.

Aug 16, 2011

Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.

Aug 16, 2011

CHPA applauds the approach for creating a public forum to collect current research and comments to advance the science of engineered nanomaterials.

Aug 15, 2011

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