id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2003-N-0196-0100,FDA,FDA-2003-N-0196,"Letter from BASF SE (Morgan, Lewis & Bockius LLP)",Other,Letter(s),2015-10-15T04:00:00Z,2015,10,2015-10-15T04:00:00Z,,2015-10-15T14:36:02Z,,0,0,0900006481ccc9d3
FDA-2003-N-0196-0101,FDA,FDA-2003-N-0196,"Advice Letter from FDA CDER to Morgan, Lewis & Bockius LLP",Other,Letter(s),2015-10-15T04:00:00Z,2015,10,2015-10-15T04:00:00Z,,2015-10-15T14:36:07Z,,0,0,0900006481ccc9d4
FDA-2003-N-0196-0094,FDA,FDA-2003-N-0196,"Memorandum of Meeting Minutes between FDA CDER and BASF regarding Octyl Triazone and Bemotrizinol March 19, 2015",Other,Memorandum,2015-06-15T04:00:00Z,2015,6,2015-06-15T04:00:00Z,,2015-06-15T17:12:42Z,,0,0,0900006481b37d71
FDA-2003-N-0196-0093,FDA,FDA-2003-N-0196,"Letter from L'Oreal USA Products, Inc. re March 18, 2015 Meeting with FDA CDER",Other,Letter(s),2015-03-09T04:00:00Z,2015,3,2015-03-09T04:00:00Z,,2015-06-15T16:42:52Z,,0,0,0900006481a317b6
FDA-2003-N-0196-0092,FDA,FDA-2003-N-0196,"Letter from FDA/CDER to Morgan, Lewis & Bockius LLP (BASF SE) Granting Meeting Request regarding GRASE Status of Octyl Triazone and Bemotrizinol",Other,Letter(s),2015-03-09T04:00:00Z,2015,3,2015-03-09T04:00:00Z,,2015-03-09T13:52:37Z,,0,0,0900006481a33ef8
FDA-2003-N-0196-0091,FDA,FDA-2003-N-0196,Letter from FDA/CDER to L'Oreal USA Products Inc. Granting Meeting Request regarding Drometrizole Trisiloxane,Other,Letter(s),2015-03-05T05:00:00Z,2015,3,2015-03-05T05:00:00Z,,2015-03-09T13:47:26Z,,0,0,0900006481a2e7f6
FDA-2003-N-0196-0088,FDA,FDA-2003-N-0196,"Reference 28 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2) (Revision 1), September 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:59Z,,0,0,0900006481a1138e
FDA-2003-N-0196-0070,FDA,FDA-2003-N-0196,"Reference 10 - Mueller et al,  Activation of Estrogen Receptor Alpha and ERbeta by 4-Methylbenzylidene-Camphor in Human and Rat Cells:  Comparison With Phyto- and Xenoestrogens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:51Z,,0,0,0900006481a11344
FDA-2003-N-0196-0069,FDA,FDA-2003-N-0196,"Reference 9 - Ma et al,  UV Filters With Antagonistic Action at Androgen Receptors in the MDA-kb2 Cell Transcriptional-Activation Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:46Z,,0,0,0900006481a11338
FDA-2003-N-0196-0065,FDA,FDA-2003-N-0196,"Reference 5 - Janjua et al, Sunscreens in Human Plasma and Urine After Repeated Whole-Body Topical Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:20Z,,0,0,0900006481a1132f
FDA-2003-N-0196-0066,FDA,FDA-2003-N-0196,"Reference 6 - Scientific Committee on Consumer Products (SCCP)/1184/08-SCCNFP Opinion on 4-Methylbenzylidene Camphor (4-MBC) Colipa n° S60 Adopted During the 16th Plenary Meeting of June 24, 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:26Z,,0,0,0900006481a11331
FDA-2003-N-0196-0079,FDA,FDA-2003-N-0196,"Reference 19 - Faas et al, Female Sexual Behavior, Estrous Cycle and Gene Expression in Sexually Dimorphic Brain Regions After Pre- and Postnatal Exposure to Endocrine Active UV Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:59Z,,0,0,0900006481a11366
FDA-2003-N-0196-0081,FDA,FDA-2003-N-0196,"Reference 21 - Maerkel et al, Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters:  Developmental Exposure of Rats to 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:13Z,,0,0,0900006481a11376
FDA-2003-N-0196-0084,FDA,FDA-2003-N-0196,"Reference 24 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:34Z,,0,0,0900006481a1137c
FDA-2003-N-0196-0067,FDA,FDA-2003-N-0196,"Reference 7- Jimenez-Diaz et al,  Simultaneous Determination of the UV-Filters Benzyl Salicylate, Phenyl Salicylate, Octyl Salicylate, Homosalate, 3-(4-Methylbenzylidene) Camphor and 3-Benzylidene Camphor in Human Placental Tissue by LC-MS/MS. Assessment of Their In Vitro Endocrine Activity re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:33Z,,0,0,0900006481a11333
FDA-2003-N-0196-0068,FDA,FDA-2003-N-0196,"Reference 8 - Gomez et al, Estrogenic Activity of Cosmetic Components in Reporter Cell Lines:  Parabens, UV Screens and Musks re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:39Z,,0,0,0900006481a11336
FDA-2003-N-0196-0063,FDA,FDA-2003-N-0196,"Reference 3 - Janjua, et al  Systemic Absorption of the Sunscreens Benzophenone-3, Octyl-Methoxycinnamate, and 3-(4-Methyl-Benzylidene) Camphor After Whole Body Topical Application and Reproductive Hormone Levels in Humans re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:06Z,,0,0,0900006481a1104a
FDA-2003-N-0196-0075,FDA,FDA-2003-N-0196,"Reference 15 - Soeborg et al, Risk Assessment of Topically Applied Products re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:29Z,,0,0,0900006481a1135e
FDA-2003-N-0196-0077,FDA,FDA-2003-N-0196,"Reference 17 - Durrer et al, Estrogen Sensitivity of Target Genes and Expression of Nuclear Receptor Co-Regulators in Rat Prostate After Pre- and Postnatal Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:45Z,,0,0,0900006481a11362
FDA-2003-N-0196-0078,FDA,FDA-2003-N-0196,"Reference 18 - Durrer et al, Estrogen Target Gene Regulation and Coactivator Expression in Rat Uterus After Developmental Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:50Z,,0,0,0900006481a11364
FDA-2003-N-0196-0082,FDA,FDA-2003-N-0196,"Reference 22 - Maerkel et al, Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:19Z,,0,0,0900006481a11378
FDA-2003-N-0196-0060,FDA,FDA-2003-N-0196,"Over-the-Counter Sunscreen Drug Products—Regulatory Status of
Enzacamene",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-02-25T05:00:00Z,2015,2,2015-02-25T05:00:00Z,2015-04-14T03:59:59Z,2015-03-23T02:01:20Z,2015-03884,0,0,0900006481a16b76
FDA-2003-N-0196-0076,FDA,FDA-2003-N-0196,"Reference 16 -Tinwell et al, Confirmation of Uterotrophic Activity of 3-(4-Methylbenzylidine) Camphor in the Immature Rat re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:38Z,,0,0,0900006481a11360
FDA-2003-N-0196-0080,FDA,FDA-2003-N-0196,"Reference 20 - Hofkamp et al, Region-Specific Growth Effects in the Developing Rat Prostate Following Fetal Exposure to Estrogenic Ultraviolet Filters re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:07Z,,0,0,0900006481a11374
FDA-2003-N-0196-0085,FDA,FDA-2003-N-0196,"Reference 25 - Schlumpf et al, Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters-An Update re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:40Z,,0,0,0900006481a11388
FDA-2003-N-0196-0087,FDA,FDA-2003-N-0196,"Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:53Z,,0,0,0900006481a1138c
FDA-2003-N-0196-0090,FDA,FDA-2003-N-0196,"Reference 30 - International Conference on Harmonization (ICH) Toxicokinetics:  The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:20:11Z,,0,0,0900006481a1139f
FDA-2003-N-0196-0061,FDA,FDA-2003-N-0196,"Reference 1 - FDA, Guidance for industry, Photosafety Testing, May 2003 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of
Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:16:50Z,,0,0,0900006481a11046
FDA-2003-N-0196-0086,FDA,FDA-2003-N-0196,"Reference 26 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:46Z,,0,0,0900006481a1138a
FDA-2003-N-0196-0073,FDA,FDA-2003-N-0196,"Reference 13 - Schreurs et al, Estrogenic Activity of UV Filters Determined by an In Vitro Reporter Gene Assay and an In Vivo Transgenic Zebrafish Assay re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:17Z,,0,0,0900006481a1134a
FDA-2003-N-0196-0064,FDA,FDA-2003-N-0196,"Reference 4 - Schauer, et al, Kinetics of 3-(methylbenzlidene) Camphor in Rats and Humans After Dermal Application re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:12Z,,0,0,0900006481a1104c
FDA-2003-N-0196-0071,FDA,FDA-2003-N-0196,"Reference 11 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:58Z,,0,0,0900006481a11346
FDA-2003-N-0196-0083,FDA,FDA-2003-N-0196,"Reference 23 - Schlumpf et al, In Vitro and In Vivo Estrogenicity of UV Screens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:19:27Z,,0,0,0900006481a1137a
FDA-2003-N-0196-0089,FDA,FDA-2003-N-0196,"Reference 29 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry, Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:20:05Z,,0,0,0900006481a11390
FDA-2003-N-0196-0074,FDA,FDA-2003-N-0196,"Reference 14 - Seidlova Wuttke et al, Comparison of Effects of Estradiol With Those of Octylmethoxycinnamate and 4-Methylbenzylidene Camphor on Fat Tissue, Lipids and Pituitary Hormones re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:23Z,,0,0,0900006481a1134c
FDA-2003-N-0196-0062,FDA,FDA-2003-N-0196,"Reference 2 - FDA, Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:17:00Z,,0,0,0900006481a11048
FDA-2003-N-0196-0072,FDA,FDA-2003-N-0196,"Reference 12 - Schmutzler et al, Endocrine Disruptors and the Thyroid Gland-A Combined In Vitro and In Vivo Analysis of Potential New Biomarkers re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T18:18:05Z,,0,0,0900006481a11348
FDA-2003-N-0196-0057,FDA,FDA-2003-N-0196,"Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen
Innovation Act",Notice,Request for Comments,2015-01-07T05:00:00Z,2015,1,2015-01-07T05:00:00Z,2015-02-24T04:59:59Z,2015-02-24T03:14:01Z,2015-00002,0,0,09000064819a971f