Trademark Trial and Appeal Board Electronic Filing System. https://estta.uspto.gov
`
`ESTTA Tracking number:
`
`ESTTA1145771
`
`Filing date:
`
`07/09/2021
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding
`
`Applicant
`
`87448330
`
`CGTN C.V.
`
`Applied for Mark
`
`AGE IQ
`
`Correspondence
`Address
`
`ROBERT J WARD
`FOLEY & LARDNER LLP
`DALLAS IP SECTION
`2021 MCKINNEY AVE STE 1600
`DALLAS, TX 75201
`UNITED STATES
`Primary Email: ipdocketing@foley.com
`Secondary Email(s): lhemphill@foley.com, kwirtz@foley.com
`214-999-4682
`
`Submission
`
`Attachments
`
`Filer's Name
`
`Filer's email
`
`Request for remand/amendment
`
`AGE IQ -TTAB Request for Suspension and Request for Remand -2.pdf(191011
`bytes )
`AGE IQ -Req for Remand Exhibits 1-7.pdf(2452622 bytes )
`
`Lisa R. Hemphill
`
`ipdocketing@foley.com, rward@foley.com, lhemphill@foley.com,
`kwirtz@foley.com
`
`Signature
`
`Date
`
`/Lisa R. Hemphill/
`
`07/09/2021
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
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`
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`
`
`CGTN C.V.
`Applicant:
`
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`
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`
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`Trademark: AGE IQ
`
`
`
`
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`
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`
`
`
`
`
`
`
`Attn: Victoria von Vistauxx Von
`Office: TTAB
`Commissioner for Trademarks
`Trademark Trial and Appeal Board
`Filed Electronically Via ESTTA
`
`
`
`
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`
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`
`
`EX PARTE APPEAL
`SERIAL NO. 87/448330
`
`
`
`
`
`
`
`
`
`§
`§
`§
`§
`§
`§
`
`
`REQUEST TO SUSPEND PROCEEDINGS AND
`
`REQUEST FOR REMAND FOR FURTHER EXAMINATION
`
`
`
`Pursuant to 37 CFR §2.142(d), CGTN C.V. (“Applicant”), respectfully requests that the
`
`ex parte appeal identified above be suspended and requests that the application be remanded to
`
`the Examining Attorney for further review for good cause shown. (See TBMP §1207.02).
`
`The Applicant believes that good cause is established for this request by the following
`
`facts:
`
`• The Applicant would like to make new evidence of record for the Examiner’s
`
`review. (See TBMP §1209.04)
`
`• The new evidence seeks to further address the issue of the refused specimen (the
`
`only issue in this appeal) and further support Applicant’s position that the
`
`specimens are “medicated” and appropriately classified in Class 5. (See TBMP
`
`§1205.01.)
`
`• This new evidence should obviate the ground for refusal to accept the specimen,
`
`and the Examining Attorney should accept the Statement of Use and place the
`
`
`
`application in condition for registration.
`
`

`

`In the event that the Board does not grant this Request for Suspension and Remand,
`
`Applicant alternatively requests, pursuant to Section 1203.02(d) of the TTAB Manual of
`
`Procedure, an extension of time to file an appeal brief for good cause shown.
`
`Applicant incorporates by reference the prior prosecution chronology and facts set forth
`
`in the prior Request to Suspend Proceedings and Request for Remand for Further Examination.
`
`The Applicant believes that good cause is established by the following facts:
`
`I.
`
`INTRODUCTION
`
`The Examiner continues to refuse to accept Applicant’s specimens as “medicated”
`
`products that may be appropriately registered in Class 5. According to the TMEP § 1401.02 (a)
`
`the headings of the International Trademark Classes are general indications relating to the fields
`
`to which, in principle, the goods or services belong. Class 5 is for Pharmaceuticals, including
`
`medical preparations or “medicated” goods. This Class includes, in particular “medicated
`
`shampoos, soaps, lotions and dentrifrices. Further, TMEP §1401.14(a) states that
`
`-[C]osmetics, toiletry preparations, and soap are classified in Class 3, except when those
`
`goods are medicated, are for pharmaceutical purposes, or have antibacterial or disinfectant
`
`properties. In such case, the goods are classified in Class 5. -
`
`Therefore, the issue before the examiner is whether Applicant’s goods are “medicated.”
`
`The answer, as demonstrated by the information and evidence below, is, yes! Applicant’s goods
`
`meet the criteria for being “medicated” and accordingly, the specimens submitted should be
`
`accepted. Because the last specimen submitted, the substitute specimen, is the current sample of
`
`use of the mark, we are providing evidence and arguments in support of the specimen, which is a
`
`“sunscreen gel” which is akin to a lotion like product that is a Broad Spectrum SPF that protects
`
`against UVA, UVB, and HEV rays.
`
`
`
`
`
`- 2 -
`
`

`

`
`
`While the TMEP does not define “medicated,” the examiner may look to the plain and
`
`ordinary meaning to understand what the term “medicated” means. To determine the ordinary
`
`meaning, we look to the dictionary.
`
`Google’s English dictionary provide by Oxford Languages of the Oxford English
`Dictionary defines “medicated” as:
`
`
`“containing or impregnated with a drug”
`
`
`
`See attached EXHIBIT 1 printout of the Google search and definition.
`
`
`
`As gleaned from the above-referenced definition, the plain and ordinary meaning of a
`
`medicated substance is a substance that contains a drug. Thus a sunscreen product is considered
`
`“medicated” if it is or contains a drug, leading to the next question: what is a drug?
`
`
`
`According to the Merriam-Webster dictionary, a “drug” is defined as:
`
`• A substance recognized in an official pharmacopoeia or formulary;
`• a substance intended for use in the diagnosis, cure, mitigation, treatment, or
`prevention of disease;
`• a substance other than food intended to affect the structure or function of the body
`
`
`See attached EXHIBIT 2.
`
`II.
`
`APPLICANT’S GOODS ARE MEDICATED
`
`In the previous Office Action dated June 4, 2019, the examiner stated that the goods do
`
`not “treat (someone or something) with or as if with medicine”. The examiner lacked all of the
`
`information regarding the product to make an informed decision regarding whether the goods are
`
`“medicated” and how they are used to “treat with, or as with medicine.” Applicant is now
`
`providing the examiner with additional evidence to clarify the nature of the goods and put to rest
`
`any question as to whether the goods are “medicated” and are appropriately suited to be
`
`registered in Class 5.
`
`Food and Drug Administration identifies sunscreens as a Drug Product for Over-the-
`A.
`Counter Human Use
`
`
`
`
`
`- 3 -
`
`

`

`
`
`The Food and Drug Administration (“FDA”) is a governmental agency that is responsible
`
`for protecting the public health by ensuring the safety, efficacy, and security of human drugs,
`
`biological products, and medical devices by ensuring the safety of cosmetics. In 2011, the FDA
`
`announced new requirements for over-the-counter sunscreen products marketed in the U.S.
`
`
`
`The FDA published an article with some questions and answers to provide a brief
`
`overview of the regulatory actions for consumers when buying sunscreen products. One
`
`question was whether the new Final Rule applied to all cosmetics and moisturizers containing
`
`sunscreen. The answer was, “Yes. All products that claim to provide Broad Spectrum SPF
`
`protection are regulated as sunscreen drug products. Therefore, the regulations FDA has
`
`developed for OTC sunscreen drug products apply to cosmetics and moisturizers labeled with
`
`SPF values. The article also stated that broad spectrum sunscreen products protect against both
`
`UVA and UVB rays. “Scientific date demonstrated that products that are “Broad Spectrum SPF
`
`15 [or higher] have been shown to reduce the risk of skin cancer and early skin aging when used
`
`with other sun protection measures, in addition to helping prevent sunburn.” Attached as
`
`EXHIBIT 3 is a copy of the article from the FDA Administration official website.
`
`
`
`In Applicant’s Request for Reconsideration dated December 4, 2019, Applicant
`
`submitted a substitute specimen, which was the online display of Applicant’s AGE IQ Invisi-
`
`Bloc Sunscreen Gel Broad Spectrum SPF 40, with the pricing and “add to bag” button. The
`
`display includes a picture of the actual product with the mark on the packaging and also “Broad
`
`Spectrum SPF 40.” As defined by the FDA, Applicant’s goods are “Broad Spectrum SPF” with
`
`an SPF of 40, which is higher than 15, making it a sunscreen drug product, regulated by the FDA
`
`which helps in the prevention of skin cancer and early skin aging.
`
`
`
`
`
`- 4 -
`
`

`

`
`
`B.
`
`Active Ingredients in Applicant’s Product Treat a Condition
`
`
`
`In further support of the nature of Applicant’s product, Applicant advises the examiner
`
`that the AGE IQ Invisi-Bloc sunscreen product lists the following active ingredients:
`
`Homosalate, Octisalate, Avobenzone, and Octocrylene. Attached as EXHIBIT 4 is a copy of the
`
`webpages describing all of the ingredients in the product, including the active ingredients.
`
`
`
`Title 21 of the Code of Federal Regulations §352 of the Sunscreen Drug Products
`
`approved for over-the-counter human use, sets forth the active ingredients that have been
`
`approved for use. Attached at EXHIBIT 5 is a copy of Section 352.20 entitled “Sunscreen
`
`active ingredients” that sets forth all of the approved active ingredients approved for sunscreen
`
`use. Included in the list are all of the active ingredients stated in Applicant’s product.
`
`
`
`Clearly, upon reviewing this new information, the examiner will be persuaded that
`
`Applicant’s specimen is acceptable and appropriately classified in Class 5.
`
`
`
`For additional support, Applicant turns to the Trademark Office registry where there are
`
`numerous registrations for sunscreens registered in Class 5.
`
`
`
`Below is a list of subsisting registrations for non-medicated sunscreens in Class 3 and
`
`medicated sunscreens in Class 5 in which the Applicant submitted the exact same specimen for
`
`both classes and the specimens were accepted.
`
`Trademark
`
`Registration
`No.
`
`Registration Date Owner Information
`
`BEACH BEAR
`
`6,257,220
`
`January 26, 2021
`
`DermaCare Labs, LLC
`
`UV RESTORE
`
`6,324,110
`
`April 13, 2021
`
`Elta MD, Inc.
`
`KLENSKIN
`
`6,344,871
`
`May 11, 2021
`
`CoLabs Int’l Corp., Inc.
`
`
`
`
`
`
`
`- 5 -
`
`

`

`Attached hereto as EXHIBIT 6 are copies of the Certificates of Registration for the above-
`
`identified registrations and their respective specimens that were submitted in support of use of
`
`the respective marks.
`
`
`
`In addition, there are numerous registrations for marks that cover sunscreens in Class 5
`
`and some that cover sunscreens in Classes 3 and 5. Below are samples of such registrations:
`
`Trademark
`
`Registration
`No.
`
`Registration Date Owner Information
`
`KLEAR
`
`6,359,575
`
`May 25, 2021
`
`Klear Cosmetics, LLC
`
`ADVANCED
`PROFESSIONAL
`SKINCARE
`
`6,345,296
`
`May 11, 2021
`
`Circadia by Dr. Pugliese, Inc.
`
`SKINPLICITY
`
`6,354,080
`
`May 18, 2021
`
`Atlantic Dermatologic Associates,
`LLP
`
`ZINC SIX-0
`
`6,337,194
`
`April 27, 2021
`
`Astivita Limited
`
`ZINC FIVE-0
`
`6,337,193
`
`April 27, 2021
`
`Astivita Limited
`
`ZINC THREE-0
`
`6,337,192
`
`April 27, 2021
`
`Astivita Limited
`
`PINCH A PENNY
`POOLS
`
`6,286,577
`
`March 9, 2021
`
`Advance Nanotek Limited
`
`SOLAR PLEX
`
`6,309,593
`
`March 30, 2021
`
`Vi-Jon, LLC
`
`MOTHER’S
`LITLE HELPER
`
`6,329,440
`
`April 20, 2021
`
`Leto Brands, LLC
`
`6,399,676
`
`June 29, 2021
`
`Cell Premium GmbH
`
`6,309,398
`
`March 30, 2021
`
`L’Oreal USA Creative, Inc.
`
`
`
`
`
`
`
`Attached as EXHIBIT 7 are copies of the Certificates of Registration for the above-referenced
`
`registrations.
`
`
`
`
`
`- 6 -
`
`

`

`Surely, after considering this new evidence, the Examiner will accept the Statement of
`
`Use and pass the application for registration of the mark.
`
`III.
`
`CONCLUSION
`
`Based on the good cause shown above, Applicant respectfully requests that the Office
`
`suspend the appeal and remand the application back to the jurisdiction of the Examiner for
`
`further consideration of the new evidence herein provided. Given the foregoing, we trust that the
`
`objection to Applicant’s specimens in Class 5 has been satisfactorily resolved and we look
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`forward to receipt of the notice of acceptance of the Statement of Use. Accordingly, this request
`
`is not made to further delay this proceeding, but is made in anticipation of the mark being
`
`accepted for registration and removing this matter from the Board’s docket.
`
`
`
`
`
`Date: July 9, 2021
`
`
`
`
`
`Respectfully submitted,
`
`FOLEY & LARDNER LLP
`
`
`
`
`
`
`
`By: /Lisa R. Hemphill/
`
`Lisa R. Hemphill
`
`Attorneys for Applicant
`2021 McKinney Ave., Suite 1600
`Dallas, Texas 75201
`
`
`
`
`4849-1892-2737.1
`
`- 7 -
`
`

`

`€<€7r¢c?
`" Apps
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`Dictionary
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`Definitionsfrom Ocford Languages
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`~ Translations and more definitions
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`{am undera lot of care. and right now as we talk! am extremely medicated Porn Professor
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`Youvisited this page on 7/9/21
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`https:/Awav.meniam-webster.com > diclianary + medic
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`EXHIBIT
`1
`
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`@ memniam-webster.com/dictionary/drug
`> SC Qs
`fi Apps
`8 Decipher @ smartshoporg
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`GAMES & QUIZZES
`THESAURUS
`WORD OF THE DAY
`FEATURES
`SHOP.
`LOG IN
`REGISTER
`[53
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`[Relat
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`Ads by Google
`
`Definition of drug (Entry 1 of 3)
`1
`a
`:asubstance used as a medication or in the preparation of medication
`
`b
`
`according to the Food, Drug, and Cosmetic Act
`
`(1) : a substance recognizedin an official pharmacopoeia or formulary (see
`FORMULARYsense 3)
`
`WORD OF THE DAY
`
`(2) : a substance intendedfor use in the diagnosis, cure, mitigation,
`treatment, or prevention of disease
`// prescription drugs
`// drugs for treating high blood pressure
`(3) : a substance other than food intended to affect the structure or function
`of the body
`(4) : a substance intended for use as a componentof a medicine but not a
`device or a component, part, or accessory of a device
`
`ale a Lo y ®
`See Definitions and Examples »
`
`Get Word ofthe Day daily email!
`Your email address Artist
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`EXHIBIT
`2
`
`2
`
` : something and often an illegal substance that causes addiction, habituation
`(see HABITUATIONsense 2b), or a marked changein consciousness
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`

`7/9/2021
`
`Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | FDA
`
`Questions and Answers: FDA announcesnew requirements
`for over-the-counter (OTC) sunscreen products marketedin
`the U.S.
`
`[updated 6/23/2011]
`
`On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements
`for sunscreenscurrently sold over-the-counter (OTC)(i.e. non-prescription). These
`requirements support the Agency's ongoing efforts to ensure that sunscreens meet modern-day
`standardsfor safety and effectiveness. The new requirements, as well as several proposed
`changesfor future rules, are outlined in four regulatory documentsthat include a Final Rule, a
`Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Draft Guidance for Industry.
`
`The following questions and answersprovidea brief overview of the recent regulatory actions
`and highlight the most important information for consumers to know whenbuying and using
`sunscreen products.
`
`States?
`
`Q2. When will these changestake effect?
`
`Q3. Whatdoes the SPF value on sunscreenlabels indicate?
`
`Q4. Does FDAbelieve sunscreensare still safe and effective? Do consumers need
`to throw away the sunscreensthey are currently using?
`
`Q5. What do consumers most need to know when buying and using sunscreens?
`
`
`
`
`
`Q6,.Whatarethemainpoints of the new Final Rule?
`
`Q7. Does the Final Rule apply to cosmetics and moisturizers containing
`sunscreen?
`
`Q8. What does the Proposed Rule address?
`
`Qo. Whatis the purpose of the Advance Notice of Proposed Rulemaking (ANPR)?
`
`
`Q1o0. Whyis the Advance Notice of Proposed Rulemaking(ANPR) re
`additional data on sunscreen products in the form of sprays?
`
`EXHIBIT
`3
`
`Qu1. Whatis included in the Draft Guidance for Industry?
`
`https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-announces-new-requirements-over-counter-otc-sunscre...
`
`1/7
`
`

`

`7/9/2021
`
`Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | FDA
`
`Qi2. Why isn't FDAfinalizing all the proposed sunscreen changes under one rule?
`
`Q13. Wherecan I find more information on these various regulatory actions?
`
`Q14. Wherecan I find more information on sunscreen use?
`
`States?
`
`A. FDAis making changes to how sunscreensare marketed in the United Statesas part of the
`Agency's ongoing efforts to ensure that sunscreens meet modern-day standardsfor safety and
`effectiveness and to help consumershavethe information they need so they can choosethe right
`sun protection for themselves andtheir families. Prior rules on sunscreens dealt almost
`exclusively with protection against sunburn, whichis primarily caused by ultraviolet B (UVB)
`radiation from the sun, and did not addressultraviolet A (UVA)radiation, which contributes to
`skin cancerandearly skin aging. After reviewing the latest science, FDA determinedthat
`sufficient data are available to establish a "broad spectrum"test for determining a sunscreen
`product's UVAprotection. Passing the broad spectrum test showsthat the product provides
`UVAprotection that is proportional to its UVB protection.
`
`Sunscreen products that pass the broad spectrum test are allowed to be labeled as "Broad
`Spectrum." These "Broad Spectrum”sunscreensprotect against both UVA and UVB rays.
`
`Scientificdatademonstratedthatproductsthatare"BroadSpectrumSPF15[orhigher]"have
`beenshowntoreducetheriskofskincancerandearlyskinagingwhenusedwithothersun
`protectionmeasures,inadditiontohelpingpreventsunburn.Other sun protection measures
`includelimiting timein the sun and wearing protective clothing.
`
`These testing and labeling requirements are necessary to provide consumerswith the
`information they need to make informedchoices whenselecting sunscreens.
`
`Qz2. Whenwill these changestake effect?
`
`A. The Final Rule will take effect by the summerof 2012, but consumers maybegin to see
`changesto sunscreenlabels before the effective date.
`
`Q3. What doesthe SPF value on sunscreenlabels indicate?
`
`A.The SPF valueindicates the level of sunburn protection provided by the sunscreen product.
`All sunscreens must be tested according to an SPFtest procedure. The test measures the amount
`of ultraviolet (UV) radiation exposure it takes to cause sunburn whena personis using a
`sunscreen in comparison to how much UV exposureit takes to cause a sunburn whenthey daa
`not use a sunscreen. The productis then labeled with the appropriate SPF value indicatingthe?
`
`https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fda-announces-new-requirements-over-counter-otc-sunscre...
`
`2/7
`
`

`

`7/9/2021
`Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | FDA
`amountof sunburn protection providedby the product. Higher SPF values (up to 50) provide
`greater sunburn protection. Because SPF values are determined from a test that measures
`protection against sunburn causedby ultraviolet B (UVB) radiation, SPF values only indicate a
`sunscreen's UVB protection.
`
`However, sunscreensthat pass the new broad spectrum test will have demonstrated that they
`also provide ultraviolet A (UVA) protection that is proportional to their UVB protection. To pass
`the broad spectrumtest, sunscreens with higher SPF valueswill provide higher levels of UVA
`protection as well. Therefore, under the new label requirements, a higher SPF value for
`sunscreenslabeled "Broad Spectrum SPF [value]" will indicate a higherlevel of protection from
`both UVA and UVB radiation.
`
`Q4. Does FDA believe sunscreensarestill safe and effective? Do consumers need
`to throw awaythe sunscreensthey are currently using?
`
`A. The ingredients in FDA-approved sunscreens marketed today have been used for manyyears,
`and FDAhasnoreasonto believe these products are not safe and effective when used as
`directed. Therefore, FDA is not advising consumersto throw awaytheir current sunscreen
`products.
`
`Sunscreenson the shelf today may have varyinglevels of ultraviolet A (UVA) radiation
`protection, but by next year, sunscreensthat claim to provide UVAprotection, otherwise known
`as broad spectrum protection, will be required to pass FDA's standardizedtest. This broad
`spectrum test will enable consumers to determinethe level of UVA protection a sunscreen
`providesin additionto its ultraviolet B (UVB) radiation protection. This information will allow
`them to better managetheir skin cancer andearly skin aging risks. FDA does not want
`consumersto stop using currently marketed sunscreensin the meantime,as these productsstill
`offer sun protection.
`
`It is also importantto note that FDAis not questioning the safety of any ingredients used in
`marketed sunscreens. FDA believes the risk of not using sunscreen is much greater than any
`potential risk posed by sunscreen ingredients.
`
`Q5. What do consumers most need to know when buying and using sunscreens?
`
`A. Spending timein the sun increasesa person'srisk of skin cancer and early skin aging.To
`reducethese risks, consumers should regularly use a Broad Spectrum sunscreen with an SPF
`value of 15 or higher in combination with other protective measuressuchas:
`
`e Limiting time in the sun, especially between the hours of 10 AM and 2 PM whenthe sun's
`rays are the strongest.
`e Wearing clothing to cover skin exposedto the sun (long-sleevedshirts, pants, sunglasses, ()
`and broad-brimmedhats) whenpossible.
`
`A
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`Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. | FDA
`
`¢ Using a waterresistant sunscreen if swimmingor sweating.
`
`¢ Reapplying sunscreen,evenif it is labeled as waterresistant, at least every 2 hours. (Water
`resistant sunscreens should be reapplied more often after swimmingor sweating,
`accordingto the directions on thelabel.)
`
`Consumersshould also be aware that no sunscreens are "waterproof" because all sunscreens
`eventually wash off. Sunscreenscan only be labeled as "water resistant” if they are tested
`according to the required SPF test procedure. Sunscreenslabeled "water resistant" sunscreens
`will also be required to state whether the sunscreen remainseffective for 40 minutes or 80
`minutes when swimming or sweating, andall sunscreenswill be required to provide directions
`on whento reapply.
`
`Q6. Whatare the main points of the new Final Rule?
`
`A.The newfinal rule includesthe following requirements:
`
`¢ Broad Spectrum designation. Sunscreensthat pass FDA's broad spectrum test
`procedure, which measures a product's ultraviolet A (UVA) protectionrelative toits
`ultraviolet B (UVB) protection, may be labeled as "Broad Spectrum SPF[value]" on the
`front label. For Broad Spectrum sunscreens, SPFvaluesalso indicate the amountor
`magnitudeof overall protection. Broad Spectrum SPF products with SPFvalues higher
`than 15 provide greater protection and mayclaim additional uses, as described in the next
`bullet.
`
`¢ Use claims. Only Broad Spectrum sunscreenswith an SPF valueof 15 or higher can claim
`to reducethe risk of skin cancer and early skin aging if used as directed with other sun
`protection measures. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens
`with an SPF value between 2 and 14 can only claim to help prevent sunburn.
`
`e "Waterproof," "sweatproof" or "sunblock" claims. Manufacturers cannotlabel
`sunscreensas "waterproof" or "sweatproof," or identify their products as "sunblocks,"
`becausetheseclaims overstate their effectiveness. Sunscreensalso cannotclaim to provide
`sun protection for more than 2 hours without reapplication or to provide protection
`immediately after application (for example-- "instant protection") without submitting data
`to support these claims and obtaining FDA approval.
`
`¢ Waterresistance claims. Waterresistance claims on the front label must indicate
`whetherthe sunscreen remainseffective for 40 minutes or 80 minutes while swimmingor
`sweating, based on standard testing. Sunscreensthat are not water resistant must include
`a direction instructing consumersto use a waterresistant sunscreen if swimming or
`sweating.
`
`¢ Drug Facts.All sunscreens must include standard "Drug Facts" information on the ba¢k
`and/orside ofthe container.
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`
`Q7. Does the Final Rule apply to cosmetics and moisturizers containing
`sunscreen?
`
`A.Yes.AllproductsthatclaimtoprovideBroadSpectrumSPFprotectionareregulatedas
`
`sunscreendrugproducts. Therefore, the regulations FDA has developed for OTC sunscreen drug
`products apply to cosmetics and moisturizers labeled with SPF values.
`
`Q8. Whatdoes the Proposed Rule address?
`
`A.Theproposedrule,if finalized, would limit the maximum SPFvalue on sunscreenlabels to
`"50 +" because thereis not sufficient data to show that products with SPF values higher than 50
`provide greater protection for users than products with SPF valuesof 50.
`
`The proposedregulationis available for public commentat regulations.gov
`(http://www.regulations.gov/) until September 15, 2011.
`
`Qo. Whatis the purpose of the Advance Notice of Proposed Rulemaking (ANPR)?
`
`A. The Advance Notice of Proposed Rulemaking (ANPR)allowsthe public a period of time to
`comment on regulations FDA may pursueas part of future rulemaking. In developing
`regulations for over-the-counter (OTC) sunscreens, FDA has not previously specified to which
`dosage formsthe regulations would apply. Therefore, FDA is requesting additional data relating
`to sunscreen products in specific dosage formsto further our understanding of how dosage
`formsaffect the safety and effectiveness of sunscreen products. For example, the ANPRinvites
`public commenton possible directions for use of and warnings for sunscreen sprays, as well as
`supporting data or information for sprays and other sunscreen dosage formsincludinglotions,
`oils, sticks, gels, butters, ointments, creams, and pastes. The ANPRalso explains how interested
`parties can supply information for FDA to consider other dosage forms, including powders,
`towelettes, body washes, and shampoos.
`
`Qio. Whyis the Advance Notice of Proposed Rulemaking(ANPR)requesting
`additional data on sunscreen products in the form of sprays?
`
`A. Currently, the record (data and information) about sunscreens in spray dosage formsis not
`comparable to that for sunscreens in other dosage formssuchasoils, creams, and lotions. The
`mannerof application differs significantly between sprays and these other dosage forms.
`Therefore, we are requesting additional data to address questionsof effectiveness and safety
`that arise from differences in the mannerof application.
`
`Qu1. Whatis includedin the Draft Gui
`
`for In
`
`1?
`
`A. The Draft Guidance for Industry, entitled "Enforcement Policy - OTC Sunscreen Drug
`Products Marketed Without an Approved Application (PDF - 83KB)
`(/media/80403/download),” is an enforcement guidancethat includes information to help
`
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`sunscreen product manufacturers understand howto label andtest their productsin light of the
`new Final Rule, the Proposed Rule, and the Advance Notice of Proposed Rulemaking (ANPR).
`
`
`Q12. Whyisn't FDAfinalizing all the proposed sunscreen changes under one rule?
`
`A.FDAisfinalizing those changesthat are based on proposals it madein earlier stages of
`rulemaking, including a 2007 proposedrule, on whichit already received public comment.
`Those commentsalso helped to inform the Agency's thinking about additional aspects of
`sunscreen regulation, which in turn gave rise to the Proposed Rule and Advance Notice of
`Proposed Rulemaking (ANPR). The regulatory process requires FDAto give public notice and
`opportunity for commentbefore finalizing additional changes, whichalso gives the public and
`FDA an opportunity to further develop the record (data and information) on safety and
`effectiveness.
`
`Q13. Where can I find more information on these various regulatory actions?
`
`
`A. On June17, 2011, FDA published the new sunscreen Final Rule (PDF - 485KB)
`(http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf), the Proposed Rule (PDF
`-197KB)(http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14769.pdf), the Advance
`
`Notice of Proposed Rulemaking(ANPR)(PDF - 187KB)(http://www.gpo.gov/fdsys/pkg/FR-
`2011-06-17/pdf/2011-14768.pdf) and the notice of availability of the Draft Guidance for
`Industry(PDF - 217KB)(http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14767.pdf),
`in the Federal Register. The draft guidance entitled "Enforcement Policy - OTC Sunscreen Drug
`
`Products Marketed Without an Approved Application" (PDF - 83KB)
`(/media/80403/download), is also available.
`
`Q14. Where can I find more information on sunscreen use?
`
`A.Additional information about FDA's changesto sunscreen regulations can be foundat
`www.fda.gov/sunscreen (/drugs/understanding-over-counter-medicines/sunscreen-how-help-
`protect-your-skin-sun), At this link, consumers can see what new sunscreenlabels will looklike,
`whattypes of sun protection various sunscreenswill provide, and howto use sunscreenssafely
`andeffectively.
`
`In addition, FDA responded to common questions about the new sunscreen regulations
`submitted by the WebMD community via Twitter and Facebook. These questions and FDA's
`responses can be found at WebMD Newsroom: FDA's New Sunscreen Rules - FAQ
`(http://blogs.webmd.com/breaking-news/2011/06/fdas-new-sunscreen-rules-fag.html) 4
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer).
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`Related Information
`
`e Sunscreen Information (/drugs/understanding-over-counter-medicines/sunscreen-how-
`help-protect-your-skin-sun)
`
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`HOW TO USE
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`INGREDIENTS
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`How To Use
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`-Age1Q® Invisi-Bloc® Sunscreen Gel
`
`Pump the sunscreen into your palm and apply generously overyour face, neck, décolletage and hands -
`anywhere skin is exposed.
`
`Invisi-Bloc works best when applied after your moisturizer and before makeup,if you wear any. Reapply every
`two hours.
`
`Ingredients
`
`EXEUBIT
`
`4
`
`Eco-Veil™
`A proprietary blend that
`mimics your skin’s natural
`barrier to form a clear shield
`
`Innovative
`Encapsulation
`Technology
`
`Antioxidant
`Complex
`
`A powerful blend of vitamins
`E and P (bioflavonoids), aloe
`
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