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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. -
Sunscreen Faqs
Sunscreen FAQs What type of sunscreen should I use? There are two main types of sunscreen ingredients: physical sun blockers and chemical sunscreens. Physical sunscreens prevent ultraviolet light from reaching your skin, and contain either zinc oxide or titanium dioxide. Physical sunscreens protect against UVA and UVB damage. Physical sunscreens are preferred for patients with sensitive skin or children. Chemical sunscreens rely on an interaction between the sun and the chemical to protect your skin. Examples of such chemicals are avobenzone, octinoxate, homosalate, padimate O, and many others. Chemical sunscreens can protect against UVA, UVB, or both types of damage, depending on which ingredient is used. Read the label to ensure coverage for both UVA and UVB exposure. There are new ingredients being developed that take chemical sunscreens and stabilize them to prolong their activity (i.e., Helioplex, Mexoryl). Does the SPF really matter? In laboratory testing, there are minor differences between SPF 15 and SPF 30 or greater products. However, that data is based on using 1 oz. (30 gm.) of sunscreen for each full body application (the size of a shot glass). Most people use far less in real-life settings. For that reason, we recommend an SPF of at least 30. It is common to find good sunscreens with SPF ranging from 45-70. To maintain protection, reapply sunscreen every 1-3 hours, depending on sweating, water exposure, and sun intensity. Is sunscreen alone enough to protect my skin in the sun? In some cases, yes. However, if you are in the sun for longer periods on a regular basis (such as gardening, golfing, boating, sports), it may be better to add sun protective clothing or habits. -
FDA Proposes Sunscreen Regulation Changes February 2019
FDA Proposes Sunscreen Regulation Changes February 2019 The U.S. Food and Drug Administration (FDA) regulates sunscreens to ensure they meet safety and eectiveness standards. To improve the quality, safety, and eectiveness of sunscreens, FDA issued a proposed rule that describes updated proposed requirements for sunscreens. Given the recognized public health benets of sunscreen use, Americans should continue to use broad spectrum sunscreen with SPF 15 or higher with other sun protective measures as this important rulemaking eort moves forward. Highlights of FDA’s Proposals Sunscreen active ingredient safety and eectiveness Two ingredients (zinc oxide and titanium dioxide) are proposed to be safe and eective for sunscreen use and two (aminobenzoic acid (PABA) and trolamine salicylate) are 1 proposed as not safe and eective for sunscreen use. FDA proposes that it needs more safety information for the remaining 12 sunscreen ingredients (cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone). New proposed sun protection factor Sunscreen dosage forms (SPF) and broad spectrum Sunscreen sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are requirements 2 proposed as safe and eective. FDA 3 • Raise the maximum proposed labeled SPF proposes that it needs more data for from SPF 50+ to SPF 60+ sunscreen powders. • Require any sunscreen SPF 15 or higher to be broad spectrum • Require for all broad spectrum products SPF 15 and above, as SPF increases, broad spectrum protection increases New proposed label requirements • Include alphabetical listing of active ingredients on the front panel • Require sunscreens with SPF below 15 to include “See Skin Cancer/Skin Aging alert” on the front panel 4 • Require font and placement changes to ensure SPF, broad spectrum, and water resistance statements stand out Sunscreen-insect repellent combination 5 products proposed not safe and eective www.fda.gov. -
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. -
Sunscreen Alternatives Sunscreen Alternatives
Sunscreen Alternatives We all know that the sun can be damaging in many ways, but most sunscreens on the market have some questionable, if not dangerous, ingredients. Here are a few ways to play it safe in the sun without putting your health at risk. 1. Common Sense We all know it but often forget: Avoid midday (10 am-2 pm) sun as much as possible, stay in the shade when possible, wear sunglasses and sun hats, don’t stay out exposed for too long. 2. Cover Up! For short periods, especially early or late in the day, sunscreen may not be necessary. In fact, a little exposure every day is vital to keep our Vitamin D levels up! Instead cover the skin with lightweight, tightly woven clothing, and protect your face with a hat. Babies under 6 months especially need to be covered up, since they don’t yet have the protection of melanin. 3. Be a Label Reader Not all sunscreens are created equal. The “worst” chemicals to avoid include Oxybenzone and PABA/Padimate O. Some active ingredients that have been found less toxic include Titanium Dioxide and Zinc Oxide. 4. CaliCaliforniafornia Baby This very eco-friendly company makes three of the top ten sunscreens on Environmental Working Group’s “Low Health Hazard/Low Sun Hazard/Most Effective” list: the SPF 30+ No Fragrance Sunblock Stick, the SPF 30+ Everyday Sunblock Stick, and the SPF 30+ Everyday Lotion. They are widely available and reasonably priced. 5. Homemade There are many recipes out there for DIY sunscreen. Here’s one to try: In a double boiler over medium heat, mix 2 ½ oz sesame oil, 1 ½ oz coconut oil, and 1 ½ oz beeswax. -
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) -
Jan 19, 2009 Listing of Generic, Non
http://www.medword.com/uspa.html Jan 19, 2009 Listing of generic, non-prescription, prescription, and OTC (over-the-counter) p harmaceuticals A-200 Gel Concentrate A-200 Shampoo Concentrate A-25 A-Cillin A-Fil A-Hydrocort A-methaPred A-Phedrin A-Spas S/L A Plus A.C. & C. A.P.L. A.R.M. Allergy Relief A.R.M. Maximum Strength Caplets A/B Otic A/Fish Oil A/T/S abacavir abarelix-depot-F abarelix-depot-M Abbokinase Abbokinase Open-Cath Abelcet Abenol Abitrate Absorbine Athletes Foot Absorbine Jock Itch Absorbine Jr. Antifungal AC acarbose Accolate Accupep HPF Accupril Accuretic Accutane Accutane Roche acebutolol Acel-Imune Acellular DTP Aceon Acet-2 Acet-3 Acet Codeine 30 Acet Codeine 60 Aceta Aceta Elixir Aceta Tablets acetaminophen acetaminophen-butalbital acetaminophen-caffeine acetaminophen-chlorpheniramine acetaminophen-codeine acetaminophen-dextromethorphan acetaminophen-diphenhydramine acetaminophen-hydrocodone acetaminophen-oxycodone acetaminophen-phenyltoloxamine acetaminophen-propoxyphene acetaminophen-propoxyphene hydrochloride acetaminophen-propoxyphene napsylate acetaminophen-pseudoephedrine acetazolam acetazolamide Acetest acetic acid Acetocot acetohexamide acetophenazine Acetoxyl 10 Gel Acetoxyl 2.5 Gel Acetoxyl 20 Gel Acetoxyl 5 Gel acetylsalicylic acid Achromycin Achromycin V aciclovir Acid Control Acid Phos Fluor Rinse Acilac Aciphex acitretin Aclophen Aclovate Acne-10 Lotion Acne-5 Lotion Acne-Aid Aqua Gel Acne-Aid Gel Acne-Aid Vanishing Cream Acne Aid 10 Cream Acne Lotion 10 Acne Prone Skin Sunscreen Acne Wash Acno Acnomel -
Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and in Vitro Methods
cosmetics Review Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and In Vitro Methods Silvia Tampucci * ID , Susi Burgalassi ID , Patrizia Chetoni ID and Daniela Monti ID Department of Pharmacy, University of Pisa, 56126 Pisa, Italy; [email protected] (S.B.); [email protected] (P.C.); [email protected] (D.M.) * Correspondence: [email protected] Received: 1 November 2017; Accepted: 7 December 2017; Published: 25 December 2017 Abstract: Sunscreens are the most common products used for skin protection against the harmful effects of ultraviolet radiation. However, as frequent application is recommended, the use of large amount of sunscreens could reflect in possible systemic absorption and since these preparations are often applied on large skin areas, even low penetration rates can cause a significant amount of sunscreen to enter the body. An ideal sunscreen should have a high substantivity and should neither penetrate the viable epidermis, the dermis and the systemic circulation, nor in hair follicle. The research of methods to assess the degree of penetration of solar filters into the skin is nowadays even more important than in the past, due to the widespread use of nanomaterials and the new discoveries in cosmetic formulation technology. In the present paper, different in vitro studies, published in the last five years, have been reviewed, in order to focus the attention on the different methodological approaches employed to effectively assess the skin permeation and retention of sunscreens. Keywords: sunscreens; formulation; in vitro methods; cutaneous permeation; skin penetration 1. Introduction The detrimental effects of human exposure to ultraviolet (UV) radiation have been widely investigated and can be immediate, as in the case of sunburns, or long-term, causing, in most cases, the formation of oxidizing species responsible of photo-aging, immunosuppression and chronic effects such as photo carcinogenicity [1,2]. -
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. -
Food and Drug Administration, HHS § 352.20
Food and Drug Administration, HHS § 352.20 (c) Cinoxate up to 3 percent. than 2 to the finished product. The fin- (d) [Reserved] ished product must have a minimum (e) Dioxybenzone up to 3 percent. SPF of not less than the number of (f) Homosalate up to 15 percent. sunscreen active ingredients used in (g) [Reserved] the combination multiplied by 2. (h) Menthyl anthranilate up to 5 per- (2) Two or more sunscreen active in- cent. gredients identified in § 352.10(b), (c), (i) Octocrylene up to 10 percent. (e), (f), (i) through (l), (o), and (q) may (j) Octyl methoxycinnamate up to 7.5 be combined with each other in a single percent. product when used in the concentra- (k) Octyl salicylate up to 5 percent. tions established for each ingredient in (l) Oxybenzone up to 6 percent. § 352.10. The concentration of each ac- (m) Padimate O up to 8 percent. tive ingredient must be sufficient to (n) Phenylbenzimidazole sulfonic contribute a minimum SPF of not less acid up to 4 percent. than 2 to the finished product. The fin- (o) Sulisobenzone up to 10 percent. ished product must have a minimum (p) Titanium dioxide up to 25 percent. SPF of not less than the number of (q) Trolamine salicylate up to 12 per- sunscreen active ingredients used in cent. the combination multiplied by 2. (r) Zinc oxide up to 25 percent. (b) Combinations of sunscreen and skin [64 FR 27687, May 21, 1999] protectant active ingredients. Any single sunscreen active ingredient or any per- EFFECTIVE DATE NOTE: At 67 FR 41823, June mitted combination of sunscreen ac- 20, 2002, § 352.10 was amended by revising tive ingredients when used in the con- paragraphs (f) through (n), effective Sept. -
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.