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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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90 rows where docket_id = "FDA-2003-N-0196" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients 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

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