US with a Gap in UVA Protection
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GAO-18-61, SUNSCREEN: FDA Reviewed Applications For
United States Government Accountability Office Report to Congressional Committees November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed GAO-18-61 November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed Highlights of GAO-18-61, a report to congressional committees Why GAO Did This Study What GAO Found Using sunscreen as directed with other The Food and Drug Administration (FDA), within the Department of Health and sun protective measures may help Human Services, implemented requirements for reviewing applications for reduce the risk of skin cancer—the sunscreen active ingredients within time frames set by the Sunscreen Innovation most common form of cancer in the Act, which was enacted in November 2014. For example, the agency issued a United States. In the United States, guidance document on safety and effectiveness testing in November 2016. sunscreen is considered an over-the- counter drug, which is a drug available As of August 2017, all applications for sunscreen active ingredients remain to consumers without a prescription. pending after the agency determined more safety and effectiveness data are Some sunscreen active ingredients not needed. By February 2015, FDA completed its initial review of the safety and currently marketed in the United States effectiveness data for each of the eight pending applications, as required by the have been available in products in act. FDA concluded that additional data are needed to determine that the other countries for more than a ingredients are generally recognized as safe and effective (GRASE), which is decade. Companies that manufacture needed so that products using the ingredients can subsequently be marketed in some of these ingredients have sought the United States without FDA’s premarket approval. -
WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 8/30 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US2012/054376 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 10 September 2012 (10.09.2012) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (26) Publication Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW. 61/532,701 9 September 201 1 (09.09.201 1) US (84) Designated States (unless otherwise indicated, for every (71) Applicant (for all designated States except US): UNIVER¬ kind of regional protection available): ARIPO (BW, GH, SITY OF FLORIDA RESEARCH FOUNDATION, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, INC. -
OSEQUE ZSOLE DUAL SUN BLOCK- Octinoxate Avobenzone Bisoctrizole Spray SONGHAK CO., LTD
OSEQUE ZSOLE DUAL SUN BLOCK- octinoxate avobenzone bisoctrizole spray SONGHAK CO., LTD. ---------- Active ingredients: Octyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Avobenzone 2%, Bisoctrizole 0.5% Purpose: Sunscreen Inactive Ingredients: Water, Alcohol Denat, Butylene Glycol, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Isononyl Isononanoate, Glacier Water, Butyloctyl Salicylate, Xanthan Gum, Decyl Glucoside, Disodium EDTA, Methylparaben, Propylparaben, Fragrance Do not use: on wounds, rashes, dermatitis or damaged skin Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately Stop use: Please stop using this product and contact a dermatologist 1. If allergic reaction or irritation occurs 2. If direct sunlight affects the area as above When using this product: Do not use other than directed Warnings: For external use only. Not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear Uses: Spray or apply liberally over the face and body 15 minutes prior to sun exposure. Always ensure total coverage of all sun exposed areas. Re-apply every 1-2 hours and always after swimming. For spray type, shake it well before use and spray it evenly at 20cm-30cm apart from face or wherever needed. For spray type - shake it well before use For lotion type - turn a cap to use Storage: Keep in a dry or room temperature area OSEQUE ZSOLE DUAL SUN BLOCK octinoxate avobenzone bisoctrizole spray Product -
Annex VI, Last Update: 02/08/2021
File creation date: 03/10/2021 Annex VI, Last update: 22/09/2021 LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS Substance identification Conditions Wording of Reference Maximum conditions of Product Type, concentration Update date number Chemical name / INN / XAN Name of Common Ingredients Glossary CAS Number EC Number Other use and body parts in ready for use warnings preparation 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl CAMPHOR BENZALKONIUM 52793-97-2 258-190-8 6% 15/10/2010 ) anilinium methyl sulphate METHOSULFATE 3 Benzoic acid, 2-hydroxy-, HOMOSALATE 118-56-9 204-260-8 10% 02/08/2021 3,3,5-trimethylcyclohexyl ester / Homosalate 4 2-Hydroxy-4-methoxybenzophenone / BENZOPHENONE-3 131-57-7 205-031-5 6% Reg (EU) Not more than Contains 02/08/2021 Oxybenzone 2017/238 of 10 0,5 % to protect Benzophenone-3 February 2017- product (1) date of formulation application from September 2017 6 2-Phenylbenzimidazole-5-sulphonic acid and its PHENYLBENZIMIDAZOLE SULFONIC 27503-81-7 248-502-0 8%(as acid) 08/03/2011 potassium, sodium and triethanolamine salts / ACID Ensulizole 7 3,3'-(1,4-Phenylenedimethylene) bis TEREPHTHALYLIDENE DICAMPHOR 92761-26-7 / 410-960-6 / - 10%(as acid) 26/10/2010 (7,7-dimethyl-2-oxobicyclo-[2.2.1] SULFONIC ACID 90457-82-2 hept-1-ylmethanesulfonic acid) and its salts / Ecamsule 8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) BUTYL 70356-09-1 274-581-6 5% 15/10/2010 propane-1,3-dione / Avobenzone METHOXYDIBENZOYLMETHANE 9 alpha-(2-Oxoborn-3-ylidene)toluene-4-sulphoni BENZYLIDENE CAMPHOR SULFONIC 56039-58-8 - 6%(as acid) -
Sun Protection
DRUG NEWS Recommending the Best Sun Protection Clinical Pearls: o Recommend a “broad-spectrum” sunscreen – one that covers UVB, UVA1, and UVA2. o Recommend SPF 30-50 o Advise on non-pharmacological sun protection methods o Emphasize proper sunscreen application technique o Emphasize skin protection when taking drugs known to cause photosensitivity. Familiarize yourself with known implicated drugs by referring to appendix 2. Background 1-4 The sun emits 3 types of ultraviolet (UV) radiation: UVC (100-290 nm), UVB (290-320 nm), and UVA (320 -400 nm). UVA rays can be further divided into the shorter UVA2 rays and the longer UVA1 rays. UVC rays, the shortest rays, are completely absorbed by the ozone layer, whereas UVB rays penetrate the epidermis and UVA rays, the longest rays, penetrate into the dermis. The main consequence of UVB irradiation is sunburn, but can also include immunosuppression and skin cancer. Consequences of UVA radiation include: phototoxicity (i.e. involvement in drug-induced sun sensitivity reactions), photo-aging, immunosuppression, and skin cancer. What is SPF? 2,5,6,7 It is easy to be misled by Sun Protection Factors (SPF). SPF is assessed through a standardized test by finding the ratio of the minimal dose of solar radiation that produces perceptible erythema (i.e., minimal erythema dose) on sunscreen-protected skin compared with unprotected skin. Sunburn is caused primarily by UVB rays (and shorter UVA2 rays), and thus SPF indicates mostly UVB protection. However, UVA protection is equally important since it is responsible for photo-aging and cancer. Therefore, it is important to look for the phrase “broad spectrum” when choosing a sunscreen as broad spectrum indicates both UVB and UVA protection. -
Four Common Sunscreen Questions – Spring 2015
Four common sunscreen questions – Spring 2015 Use this information SPF to help you advise 30 your customers about Use the Sun Protection System sunscreen use. 30 SP F 1. How do sunscreens filter the slip, slop, slap, and wrap sun’s rays? Sunscreens may contain physical or chemical Ethoxyethyl p-methoxycinnamate barriers to screen skin against the sun’s (cinoxate)) ultraviolet radiation (UV radiation). While physical barriers reflect or scatter the UV rays, » Salicylates (Homomenthyl salicylate chemical barriers act by absorbing the UV (homosalate), Ethylhexyl salicylate (octyl radiation before it hits the skin. salicylate/octisalate), Trolamine salicylate General advice is to choose a sunscreen which » Avobenzone (butyl methoxydibenzoylmethane) is broad spectrum, which means it filters both UVA and UVB rays. Those who have sensitive » Ecamsule ((terephthalylidene dicamphor skin should choose a sunscreen labelled sulfonic acid; Mexoryl SX) hypoallergenic or low irritant. » Ensulizole ((phenylbenzimidazole sulfonic Typical chemical absorbers include: acid) » Aminobenzoic acid derivatives (Glyceryl » Bemotrizinol (Tinosorb S) PABA), Padimate O, Roxadimate) » Bisoctrizole (Tinosorb M) » (Dioxybenzone, Benzophenones Physical blockers are titanium dioxide and Oxybenzone, Sulisonbenzone) zinc oxide. When applied they leave a thick » Cinnamates (Octocrylene, Octyl opaque (white) layer on the skin. Microfine or methoxycinnamate (octinoxate), nanoparticles of both are transparent on the skin and reflect UV radiation. 2. Do babies’ need a special sunscreen? » Babies’ skin is very sensitive and can sunburn easily so keep them out of the sun. » Once a baby is moving use the sun protection system. » Patch test an untried sunscreen on the skin 24 hours before applying it widely to check that there is no reaction. -
Photoprotection
Photoprotection Review Article Photoprotection Authors: ABSTRACT Gabriel Teixeira Gontijo1 2 Maria Cecília Carvalho Pugliesi Introduction: Incidence of skin cancer has increased signifi cantly in recent decades, Fernanda Mendes Araújo3 corresponding to a public health problem in many countries. Skin is the organ most affected 1Professor of Dermatology – by the deleterious effects of ultraviolet radiation and the association between sun exposure Universidade Federal de Minas Gerais; Preceptor of the and skin cancer is well-documented. Objective: To conduct a comprehensive review of the Dermatologic Surgery Department main photoprotection measures. Method: We conducted searches on MEDLINE from June at Hospital das Clinicas – 22 through August 18. Descriptive studies, review, and comparative studies were analyzed Universidade Federal de Minas Gerais together. Results: Eleven articles about a review of photoprotection, effects of ultraviolet 2Resident in Dermatology, UFMG radiation on the skin, prevalence of the use of sunscreens, and behavioral measures among 3 MD adults and adolescents were reported were selected. Conclusions: The use of broad-spectrum Correspondence to: sunscreens, besides simple behavioral measures, appears to have a major impact on prevention Gabriel Gontijo of skin cancer. Praça da Bandeira, nº 170, 4º andar Keywords: ultraviolet light, sunlight, ultraviolet fi lters, squamous cell carcinoma, basal cell Bairro Mangabeiras – Belo Horizonte – MG carcinoma, melanoma, vitamin D, stability of cosmetics. CEP: 30130-050 Tel: -
Labeling and Effectiveness Testing; I
Vol. 76 Friday, No. 117 June 17, 2011 Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201, 310, and 352 Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and Proposed Rules VerDate Mar<15>2010 18:47 Jun 16, 2011 Jkt 223001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17JNR3.SGM 17JNR3 emcdonald on DSK2BSOYB1PROD with RULES3 35620 Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: regulatory actions associated with OTC HUMAN SERVICES Reynold Tan, Center for Drug sunscreen products, please refer to our Evaluation and Research, Food and Web site: http://www.fda.gov/Drugs/ Food and Drug Administration Drug Administration, 10903 New DevelopmentApprovalProcess/ Hampshire Ave., Bldg. 22, rm. 5411, DevelopmentResources/Over-the- 21 CFR Parts 201 and 310 Silver Spring, MD 20993, 301–796– CounterOTCDrugs/StatusofOTC [Docket No. FDA–1978–N–0018] (Formerly 2090. Rulemakings/ucm072134.htm. In the Federal Register of May 12, Docket No. 1978N–0038) SUPPLEMENTARY INFORMATION: 1993 (58 FR 28194), we published a RIN 0910–AF43 Table of Contents proposed rule for OTC sunscreen products that identified active Labeling and Effectiveness Testing; I. Overview of Document A. Rulemaking History ingredients we tentatively considered to Sunscreen Drug Products for Over-the- be generally recognized as safe and Counter Human Use B. Scope of This Document C. Issues Outside the Scope of This effective (GRASE), as well as associated AGENCY: Food and Drug Administration, Document labeling and sun protection factor (SPF) HHS. -
The Effects of Ultraviolet Filters and Sunscreen on Corals and Aquatic Ecosystems Bibliography
The Effects of Ultraviolet Filters and Sunscreen on Corals and Aquatic Ecosystems Bibliography Hope Shinn, Librarian, NOAA Central Library NCRL subject guide 2019-11 doi: 10.25923/hhrp-xq11 September 2019 U.S. Department of Commerce National Oceanic and Atmospheric Administration Office of Oceanic and Atmospheric Research NOAA Central Library – Silver Spring, Maryland Table of Contents Background & Scope ................................................................................................................................. 3 Sources Reviewed ..................................................................................................................................... 3 Section I: Corals and UV Filters ................................................................................................................. 4 Section II: Endocrine Disruption/Toxicology of Coral Reef Associated Organisms ................................. 10 Section III: Environmental Fate and Life Cycle of UV Filters in Marine Environments ........................... 25 Section IV: Concentrations of UV Filters in Marine Environments ......................................................... 51 Section V: Laboratory Studies on the Toxicity and Endocrine Disruption Effects of UV Filters .............. 94 2 Background & Scope The NOAA Coral Reef Conservation Program (CRCP) is in the process of evaluating research pertaining to coral reef health, especially as concerned with ultraviolet (UV) filters in sunscreen. To that end, the NOAA Central Library reviewed -
Sunscreen Innovation Act (P.L
Report to the Committee on Health, Education, Labor, and Pensions, U.S. Senate, and the Committee on Energy and Commerce, U.S. House of Representatives Report in Response to the Sunscreen Innovation Act (P.L. 113-195) Section 586G U.S. Department of Health and Human Services Food and Drug Administration /s/ 5-4-18 ____________________________________________ Date ___________________ Scott Gottlieb, M.D. Commissioner of Food and Drugs Table of Contents Executive Summary………………………………………………………………… Page 3 Introduction………………………………………………………………….. ……… Page 4 Discussion…………………………………………………………………………… Page 4 A. Review of Progress in GRASE Determinations - Pending Requests B. Review of Progress in GRASE Determination - Post SIA Requests C. Annual Accounting of Progress D. Description of Staffing and Resources E. Progress in Meeting Deadlines F. Process Improvement Recommendations Conclusion………………………………………….............................................. Page 9 2 Executive Summary FDA is committed to doing its part to provide American consumers with additional options for safe and effective sunscreen formulations containing active ingredients that meet generally recognized as safe and effective (GRASE) standards. FDA has met all of its statutory obligations and deadlines under the Sunscreen Innovation Act (SIA) to date. FDA relies on industry to submit the data needed to support a determination that a given active ingredient is GRASE for use in nonprescription sunscreen products. We are pleased to provide additional information in this report as required by the SIA (P.L. 113- 195, Sec. 586G). Introduction The SIA, enacted on November 26, 2014 (P.L. 113-195), requires that no later than 18 months after the date of enactment of the SIA and on the date that is 2 years thereafter, a report be issued to the Committee on Health, Education, Labor, and Pensions of the U.S. -
Pollution Des Eaux Du Littoral Par Les Absorbeurs D'uv Issus De Crèmes Solaires, Générée Par Les Activités Estivales
J. Labille - Projet OHM Littoral 2017 PLAGE-UV Pollution des eaux du Littoral par les Absorbeurs d’UV issus de crèmes solaires, Générée par les activités Estivales - Phase B PLAGE-UVB Centre Européen de Recherche et Enseignement en Géosciences de l'Environnement, UM 34 CEREGE J. Labille, D. Slomberg, R. Catalano, O. Radakovitch, C. de Garidel Laboratoire de Chimie de l’Environnement, UMR 7376 LCE J.-L. Boudenne Etude des Structures, des Procédures d’Adaptation et des Changements d’Espace, UMR 7300 ESPACE R. Bertholdo, J. Ribourdouille, S. Robert, M.-L. Tremelo Surfrider Foundation Europe S. Hatimi, B. Van Hoorebeke Séminaire OHM Littoral Méditerranéen – 27/03/19 Sites d’étude • Plage du Prophète, Marseille • Plage de Pointe Rouge, Marseille • Plage de la Lave, Le Rove J. Labille - Projet OHM Littoral 2017 PLAGE-UV Des molécules organiques comme absorbeur d’UV nano-TiO Filtres minéraux nano 2 < 25% Filtres organiques dioxybenzone oxybenzone avobenzone 2-éthylhexyl-4-méthoxycinnamate octocrylène • L’utilisation des filtres minéraux et organiques ensemble est la plus répandue pour une protection de plus large spectre. • Les filtres organiques synthétiques sont interdits en produits cosmétiques bio. Analyse chimique de l’eau – Quantification TiO2 Plage du Prophète Samedi 15 juillet 2017 TiO2 900 µg/L Ti concentration in seawater �g/L en surface 600 10-16 µg/L 500 à 40 cm �g/L 400 12 10 300 8 6 200 2 m 4 50 m 100 2 200 m 0 0 Labille et al., in prep. J. Labille - Projet OHM Littoral 2017 PLAGE-UV Mesure des filtres organiques Unités Pic de concentration à 16h, (ng/L) Prophète dist 2 m, prof 40 cm 35.0 distance 2m, profondeur 40 cm, 30.0 sur les 3 plages, pendant le bain. -
Report to Senate Health, Education, Labor and Pensions Committee
Appendix A: Status of Pending SIA Requests Ingredient Date of Time Eligibility Date(s) of Feedback Statutory Date Date of Date Final and Extent Determination Industry Letter Deadline for Proposed Industry Sunscreen [Docket No.] Application Date Data Issued Proposed Sunscreen Submission of Order Issued Submission (Deemed by Sunscreen Order or Missing Data SIA’s Order or Notice enactment Notice Issued to be Thereof (in Proposed case of prior Sunscreen Feedback Order) Letter) Bemotrizinol 2/28/2006 Pending data [FDA-2005-N- 4/11/05 12/5/2005 11/13/2014 1/10/2015 1/7/2015 Pending1 11/29/2006 submission 0453] Bisoctrizole Pending data [FDA-2005-N- 4/11/05 12/5/05 2/27/06 9/3/2014 1/10/2015 1/7/2015 Pending1 submission 0453] Drometrizole Trisiloxane 1/16/09 Pending data 1/16/2009 6/2/10 8/29/2014 1/10/2015 1/7/2015 Pending2 [FDA-2003-N- 7/14/10 submission 0196] 10/3/03 Octyl Triazone 1/9/04 Pending data 8/21/02 7/11/03 6/23/2014 1/10/2015 1/7/2015 Pending1 [2003N-0233] 7/2/04 submission 12/21/06 Amiloxate Pending; No [2003N-0233 10/1/03 contact from Pending data 8/14/02 7/11/03 2/25/2014 1/10/2015 1/7/2015 SUP3 and 8/15/03 sponsor since submission RPT1] 2003 1 Meetings held with BASF, the sponsor of bemotrizinol, bisoctrizole, and octyl triazone on March 19, 2015, and March 20, 2015. Detailed written responses to all sponsor questions and minutes of these meetings were provided.