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withdrawn,object_id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-1978-N-0018-0807,FDA,FDA-1978-N-0018,"Attachments 1, 2 and 4 re: Supplement from Merck KGaA",Supporting & Related Material,Background Material,2015-03-30T04:00:00Z,2015,3,,,2019-08-09T14:13:22Z,,0,0,090000648055a66e
FDA-1978-N-0018-0806,FDA,FDA-1978-N-0018,Letter from Personal Care Products Council and Consumer Healthcare Products Association to FDA  CDER,Other,Letter(s),2015-03-20T04:00:00Z,2015,3,2015-03-20T04:00:00Z,,2015-03-20T16:22:32Z,,0,0,0900006481a549c3
FDA-1978-N-0018-0802,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:21Z,,0,0,0900006481a1130c
FDA-1978-N-0018-0805,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:50Z,,0,0,0900006481a11044
FDA-1978-N-0018-0788,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:02Z,,0,0,0900006481a112c8
FDA-1978-N-0018-0794,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:03Z,,0,0,0900006481a112ce
FDA-1978-N-0018-0775,FDA,FDA-1978-N-0018,"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,2015-04-14T02:11:05Z,2015-03884,0,0,0900006481a1641f
FDA-1978-N-0018-0780,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:45Z,,0,0,0900006481a10e87
FDA-1978-N-0018-0785,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:35Z,,0,0,0900006481a112c5
FDA-1978-N-0018-0795,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:12Z,,0,0,0900006481a11305
FDA-1978-N-0018-0797,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:36Z,,0,0,0900006481a11307
FDA-1978-N-0018-0798,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:47Z,,0,0,0900006481a11308
FDA-1978-N-0018-0790,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:20Z,,0,0,0900006481a112ca
FDA-1978-N-0018-0804,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:41Z,,0,0,0900006481a1130e
FDA-1978-N-0018-0779,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:38Z,,0,0,0900006481a10e86
FDA-1978-N-0018-0777,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:22Z,,0,0,0900006481a10e84
FDA-1978-N-0018-0778,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:30Z,,0,0,0900006481a10e85
FDA-1978-N-0018-0787,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:54Z,,0,0,0900006481a112c7
FDA-1978-N-0018-0796,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:27Z,,0,0,0900006481a11306
FDA-1978-N-0018-0786,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:46Z,,0,0,0900006481a112c6
FDA-1978-N-0018-0783,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:16Z,,0,0,0900006481a10e8a
FDA-1978-N-0018-0784,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:26Z,,0,0,0900006481a10e8b
FDA-1978-N-0018-0791,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:32Z,,0,0,0900006481a112cb
FDA-1978-N-0018-0799,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:36:57Z,,0,0,0900006481a11309
FDA-1978-N-0018-0801,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:14Z,,0,0,0900006481a1130b
FDA-1978-N-0018-0803,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:33Z,,0,0,0900006481a1130d
FDA-1978-N-0018-0781,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:55Z,,0,0,0900006481a10e88
FDA-1978-N-0018-0782,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:34:05Z,,0,0,0900006481a10e89
FDA-1978-N-0018-0789,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:12Z,,0,0,0900006481a112c9
FDA-1978-N-0018-0776,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:33:10Z,,0,0,0900006481a10e83
FDA-1978-N-0018-0792,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:41Z,,0,0,0900006481a112cc
FDA-1978-N-0018-0793,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:35:52Z,,0,0,0900006481a112cd
FDA-1978-N-0018-0800,FDA,FDA-1978-N-0018,"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,,,2015-02-25T17:37:05Z,,0,0,0900006481a1130a
FDA-1978-N-0018-0774,FDA,FDA-1978-N-0018,"Slide Presentation from the Sunscreen Innovation Act Stakeholder Meeting re Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act (SIA), February 4 2015, FDA-1978-N-0018-0772",Supporting & Related Material,Meeting Materials,2015-02-23T05:00:00Z,2015,2,,,2015-02-24T04:43:32Z,,0,0,0900006481a10372
FDA-1978-N-0018-0773,FDA,FDA-1978-N-0018,"Summary of Meeting re  Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act SIA February 4 2015, FDA-1978-N-0018-0772",Supporting & Related Material,Meeting Summary,2015-02-23T05:00:00Z,2015,2,,,2015-02-24T04:44:20Z,,0,0,0900006481a1036f
FDA-1978-N-0018-0772,FDA,FDA-1978-N-0018,"Meeting Announcement from FDA CDER re FDA Implementation of the Sunscreen Innovation Act (SIA), February 4 2015",Other,Memorandum,2015-01-26T05:00:00Z,2015,1,2015-01-26T05:00:00Z,,2015-02-24T04:46:31Z,,0,0,09000064819e06e0
FDA-1978-N-0018-0771,FDA,FDA-1978-N-0018,Letter from The Proprietary Association to FDA,Other,Letter(s),2015-01-05T05:00:00Z,2015,1,,,2019-08-09T17:54:57Z,,0,0,09000064805596c4