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withdrawn,object_id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
FDA-2003-N-0196-0055,FDA,FDA-2003-N-0196,"Initial Determination and Feedback Letter from FDA/CDER to L'Oreal USA Products, Inc re Time and Extent Application (TEA) Drometrizole Trisiloxane for use in Over-the-Counter (OTC) Sunscreens",Other,Letter(s),2014-08-29T04:00:00Z,2014,8,2014-08-29T04:00:00Z,,2014-08-29T21:20:12Z,,0,0,09000064818511a4
FDA-2003-N-0196-0054,FDA,FDA-2003-N-0196,"Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP)",Other,Letter(s),2014-06-23T04:00:00Z,2014,6,2014-06-23T04:00:00Z,,2014-06-23T18:14:09Z,,0,0,090000648175c494
FDA-2003-N-0196-0053,FDA,FDA-2003-N-0196,"Supplement from BASF AG (Morgan Lewis & Bockius, LLP)",Other,Supplement (SUP),2014-06-11T04:00:00Z,2014,6,2014-06-11T04:00:00Z,,2014-06-11T15:51:37Z,,0,0,090000648048b765
FDA-2003-N-0196-0051,FDA,FDA-2003-N-0196,"Data and Information from BASF AG (Morgan Lewis & Bockius, LLP)",Other,Submission of Information,2014-06-11T04:00:00Z,2014,6,2014-06-11T04:00:00Z,,2014-06-11T15:48:23Z,,0,0,090000648173afac
FDA-2003-N-0196-0052,FDA,FDA-2003-N-0196,"Supplement from BASF AG (Morgan Lewis & Bockius, LLP)",Other,Supplement (SUP),2014-06-11T04:00:00Z,2014,6,2014-06-11T04:00:00Z,,2014-06-11T15:49:59Z,,0,0,090000648048b660
FDA-2003-N-0196-0048,FDA,FDA-2003-N-0196,Letter from Symrise North America Cosmetic Division,Other,Letter(s),2014-06-09T04:00:00Z,2014,6,2014-06-09T04:00:00Z,,2014-06-09T21:19:55Z,,0,0,090000648048b606
FDA-2003-N-0196-0047,FDA,FDA-2003-N-0196,"Letter from Buchanan Ingersoll to the Division of Over-The-Counter Drug Products, July 25, 2003",Other,Letter(s),2014-06-09T04:00:00Z,2014,6,2014-06-09T04:00:00Z,,2014-06-09T21:12:37Z,,0,0,090000648048b600
FDA-2003-N-0196-0049,FDA,FDA-2003-N-0196,"Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP)",Other,Letter(s),2014-06-09T04:00:00Z,2014,6,2014-06-09T04:00:00Z,,2014-06-09T21:29:26Z,,0,0,090000648048b61b
FDA-2003-N-0196-0050,FDA,FDA-2003-N-0196,"Supplement from BASF AG (Morgan Lewis & Bockius, LLP)",Other,Supplement (SUP),2014-06-09T04:00:00Z,2014,6,2014-06-09T04:00:00Z,,2014-06-09T22:01:14Z,,0,0,090000648048b622
FDA-2003-N-0196-0039,FDA,FDA-2003-N-0196,"Volume 8 Test Substance G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:36:48Z,,0,0,090000648170431f
FDA-2003-N-0196-0044,FDA,FDA-2003-N-0196,"Volume 12 Report re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:52:30Z,,0,0,090000648170445e
FDA-2003-N-0196-0040,FDA,FDA-2003-N-0196,"Volume 7 Test Item G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:37:09Z,,0,0,090000648170431e
FDA-2003-N-0196-0046,FDA,FDA-2003-N-0196,"Volume 14 Clinical Evaluation of the Cutaneous Tolerance and Acceptance of a Cosmetic Product Applied Under Normal Conditions of Use in the Sun for Three Weeks by 30 Children  re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-07-16T19:26:05Z,,0,0,0900006481704460
FDA-2003-N-0196-0045,FDA,FDA-2003-N-0196,"Volume 13 Pediatric Use Study Reports re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:57:41Z,,0,0,090000648170445f
FDA-2003-N-0196-0035,FDA,FDA-2003-N-0196,"Volume 3 Admentment No. 1 to Final Report Dated 21 March 1996 re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:24:32Z,,0,0,090000648170431a
FDA-2003-N-0196-0037,FDA,FDA-2003-N-0196,"Volume 5 Test to Evaluate PhotoAllergic in the Guinea Pig re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:30:13Z,,0,0,090000648170431c
FDA-2003-N-0196-0043,FDA,FDA-2003-N-0196,"Volume 11 English Summary of the Report re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:48:46Z,,0,0,090000648170445d
FDA-2003-N-0196-0036,FDA,FDA-2003-N-0196,"Volume 4  re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:29:41Z,,0,0,090000648170431b
FDA-2003-N-0196-0034,FDA,FDA-2003-N-0196,"Volume 2  re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:24:53Z,,0,0,0900006481704319
FDA-2003-N-0196-0042,FDA,FDA-2003-N-0196,"Volume 10 Human Safety Study Reports re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:48:37Z,,0,0,090000648170445c
FDA-2003-N-0196-0038,FDA,FDA-2003-N-0196,"Volume 6 Determination of G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:30:31Z,,0,0,090000648170431d
FDA-2003-N-0196-0033,FDA,FDA-2003-N-0196,"Volume 1 Time and Extension Application re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-07-16T19:23:25Z,,0,0,0900006481704318
FDA-2003-N-0196-0041,FDA,FDA-2003-N-0196,"Volume 9 Test Report CCR Project 532003 re Data and Information from L'Oreal, USA Products, Inc.",Supporting & Related Material,Data,2014-05-19T04:00:00Z,2014,5,,,2014-05-19T22:44:43Z,,0,0,0900006481704320
FDA-2003-N-0196-0031,FDA,FDA-2003-N-0196,"Response Letter from FDA CDER to Symrise, Inc., and Ego Pharmaceuticals Ltd re  re Time and Extent Application TEA",Other,Letter(s),2014-02-28T05:00:00Z,2014,2,2014-02-28T05:00:00Z,,2014-05-14T11:33:42Z,,0,0,09000064815e9304
FDA-2003-N-0196-0030,FDA,FDA-2003-N-0196,Request for Extension from BASF AG and BASF Corporation,Other,Request for Extension,2014-02-14T05:00:00Z,2014,2,2014-02-14T05:00:00Z,,2014-02-14T20:44:26Z,,0,0,090000648048b5fd
FDA-2003-N-0196-0025,FDA,FDA-2003-N-0196,Amiloxate USP  Neo Heliopan E1000 by Symrise Safety Data Book 2,Other,References (internal) (REF),2014-01-07T05:00:00Z,2014,1,2014-01-07T05:00:00Z,,2014-01-07T21:40:26Z,,0,0,09000064814f1dc2
FDA-2003-N-0196-0027,FDA,FDA-2003-N-0196,Amiloxate USP Neo Heliopan E1000 by Symrise Safety Data Book 4,Other,References (internal) (REF),2014-01-07T05:00:00Z,2014,1,2014-01-07T05:00:00Z,,2014-02-28T18:17:37Z,,0,0,09000064814f1dc4
FDA-2003-N-0196-0024,FDA,FDA-2003-N-0196,"Amiloxate, USP - Neo Heliopan E1000 by Symrise Safety Data Book 1 (EU Commission Approval and Opinion of SCCNFP, Animal safety testing tabs 1-15)",Other,References (internal) (REF),2014-01-07T05:00:00Z,2014,1,2014-01-07T05:00:00Z,,2014-01-07T21:40:20Z,,0,0,09000064814f1dc1
FDA-2003-N-0196-0026,FDA,FDA-2003-N-0196,Amiloxate USP Neo Heliopan E1000 by Symrise Safety Data Book 3,Other,References (internal) (REF),2014-01-07T05:00:00Z,2014,1,2014-01-07T05:00:00Z,,2014-01-07T21:40:32Z,,0,0,09000064814f1dc3
FDA-2003-N-0196-0023,FDA,FDA-2003-N-0196,"Drometrizole Trisiloxane Eligibility for Potential Inclusion in Sunscreen Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety, Effectiveness, and Environmental Data",Notice,Notice of Solicitation,2010-06-02T04:00:00Z,2010,6,2010-06-02T04:00:00Z,2010-09-01T03:59:59Z,2014-12-18T03:05:57Z,2010-13001,0,0,0900006480afa64d
FDA-2003-N-0196-0020,FDA,FDA-2003-N-0196,Response from FDA/CDER to Buchanan Ingersoll,Other,Answer,2003-12-15T05:00:00Z,2003,12,,,2014-06-09T21:16:55Z,,0,0,090000648048b603
FDA-2003-N-0196-0021,FDA,FDA-2003-N-0196,"Response from FDA/CDER to North America Cosmetic Division, Symrise",Other,Answer,2003-12-15T05:00:00Z,2003,12,,,2014-06-09T21:22:06Z,,0,0,090000648048b618
FDA-2003-N-0196-0022,FDA,FDA-2003-N-0196,"Response from FDA/CDER to Morgan, Lewis & Bockius LLP",Other,Answer,2003-12-15T05:00:00Z,2003,12,,,2014-06-09T21:33:27Z,,0,0,090000648048b61e
FDA-2003-N-0196-0013,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b587
FDA-2003-N-0196-0007,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b56c
FDA-2003-N-0196-0016,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b596
FDA-2003-N-0196-0008,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b571
FDA-2003-N-0196-0002,FDA,FDA-2003-N-0196,"Division of OTC Drug Products Memorandum to Dockets Management, July 14, 2003 - ""Public Admlnistratlve File for Over-the-Counter Drug Products; Safety and Efficacy, Volume No. 352-01"" - Background",Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2014-06-09T20:51:58Z,,0,0,090000648048b53d
FDA-2003-N-0196-0003,FDA,FDA-2003-N-0196,"Reference 5  FDA's Evaluation and Comments on the TEA for Encacamene Division of OTC Drug Products Memorandum to Dockets Management, July 14, 2003 re Public Admlnistratlve File for Over-the-Counter Drug Products; Safety and Efficacy, Volume No. 352-01 - Background",Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2014-06-09T20:52:46Z,,0,0,090000648048b554
FDA-2003-N-0196-0009,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b577
FDA-2003-N-0196-0005,FDA,FDA-2003-N-0196,"Regulatory Review - (Ego Pharmaceuticals, Pty Ltd. - Data and Information)]",Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2010-07-16T16:03:27Z,,0,0,090000648048b561
FDA-2003-N-0196-0014,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b58b
FDA-2003-N-0196-0019,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b5a1
FDA-2003-N-0196-0004,FDA,FDA-2003-N-0196,"Table of Contents Time and Extent Application for Amiloxate - [Amiloxate, Neo Heliopan® 1000"" - (Ego Pharmaceuticals, Pty Ltd. - Data and Information)]",Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2010-07-16T16:00:52Z,,0,0,090000648048b559
FDA-2003-N-0196-0010,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b57a
FDA-2003-N-0196-0017,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b599
FDA-2003-N-0196-0011,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b580
FDA-2003-N-0196-0006,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b568
FDA-2003-N-0196-0015,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:21Z,,0,0,090000648048b592
FDA-2003-N-0196-0018,FDA,FDA-2003-N-0196,"Reference 6 - ""FDA's Evaluation and Comments on the TEA for Octyl Trlazone."" - [Division of OTC Drug Products Memorandum to Dockets Management, July 14, 2003 - ""Public Admlnistratlve File for Over-the-Counter Drug Products; Safety and Efficacy, Volume No. 352-01"" - Background]",Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2014-06-09T20:54:14Z,,0,0,090000648048b59e
FDA-2003-N-0196-0012,FDA,FDA-2003-N-0196,BACKGROUND,Supporting & Related Material,BKG-Background Material,2003-07-30T04:00:00Z,2003,7,,,2008-04-12T00:59:20Z,,0,0,090000648048b583
FDA-2003-N-0196-0001,FDA,FDA-2003-N-0196,Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients,Notice,Requests for Information (RFI),2003-07-11T04:00:00Z,2003,7,2003-07-11T04:00:00Z,2003-10-11T03:59:59Z,2014-06-14T20:55:15Z,,0,0,090000648048b511