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),whetherornotthecosmeticproductenters
interstatecommerce.Thisrequestextendstoanyforeignmanufacturer,
packer,ordistributorofacosmeticproductexportedforsaleinany
Stateasdefinedinsection201(a)
(1)oftheFederalFood,Drug,and
CosmeticAct.Nofilingfeeisrequired.
[57FR3129,Jan.28,1992]
21CFR720.2]
Sec.720.2Timesforfiling.
Within180daysafterformsaremadeavailabletotheindustry,Form
FDA2512shouldbefiledforeachcosmeticproductbeingcommercially
distributedasoftheeffectivedateofthispart.FormFDA2512should
befiledwithin60daysafterthebeginningofcommercialdistribution
ofanyproductnotcoveredwithinthe180-dayperiod.
21CFR720.3]
Sec.720.3Howandwheretofile.
FormsFDA2512andFDA2514(``DiscontinuanceofCommercial
DistributionofCosmeticProductFormulation'
)areobtainableon
requestfromtheFoodandDrugAdministration,DepartmentofHealthand
HumanServices,Washington,DC20204,oratanyFoodandDrug
Administrationdistrictoffice.Thecompletedformshouldbemailedor
deliveredto:
CosmeticProductStatement,FoodandDrugAdministration,
DepartmentofHealthandHumanServices,Washington,DC20204,according
totheinstructionsprovidedwiththeforms.
21CFR720.4]
[Page146-148]
Sec.720.4Informationrequestedaboutcosmeticproducts.
(a)FormFDA-2512requestsinformationon:
(1)Thenameandaddress,includingpostofficeZIPcodeofthe
person(manufacturer,packer,ordistributor)designatedonthelabelof
theproduct.
(2)Thenameandaddress,includingpostofficeZIPcode,ofthe
manufacturerorpackeroftheproductifdifferentfromtheperson
designatedonthelabeloftheproduct,whenthemanufacturerorpacker
submitstheinformationrequestedunderthisparagraph.
(3)Thebrandnameornamesofthecosmeticproduct.
(4)Thecosmeticproductcategoryorcategories.
(5)Theingredientsintheproduct.
[[Page147]]
(b)ThepersonfilingFormFDA-2512should:
(1)Providetheinformationrequestedinparagraph(a)ofthis
section.
(2)Havetheformsignedbyanauthorizedindividual.
(3)Providepoisoncontrolcenterswithingredientinformationand/
oradequatediagnosticandtherapeuticprocedurestopermitrapid
evaluationandtreatmentofaccidentalingestionorotheraccidentaluse
ofthecosmeticproduct.
(4)Provideingredientinformation(and,whenrequested,ingredient
samples)toalicensedphysicianwho,inconnectionwiththetreatment
ofapatient,requestsassistanceindeterminingwhetheraningredient
inthecosmeticproductisthecauseoftheproblemforwhichthe
patientisbeingtreated.
(c)Oneormoreofthefollowingcosmeticproductcategoriesshould
becitedtoindicatetheproduct'
sintendeduse.
(1)Babyproducts.(i)Babyshampoos.
(ii)Lotions,oils,powders,andcreams.
(iii)Otherbabyproducts.
(2)Bathpreparations.(i)Bathoils,tablets,andsalts.
(ii)Bubblebaths.
(iii)Bathcapsules.
(iv)Otherbathpreparations.
(3)Eyemakeuppreparations.(i)Eyebrowpencil.
(ii)Eyeliner.
(iii)Eyeshadow.
(iv)Eyelotion.
(v)Eyemakeupremover.
(vi)Mascara.
(vii)Othereyemakeuppreparations.
(4)Fragrancepreparations.(i)Colognesandtoiletwaters.
(ii)Perfumes.
(iii)Powders(dustingandtalcum)(excludingaftershavetalc).
(iv)Sachets.
(v)Otherfragrancepreparations.
(5)Hairpreparations(noncoloring).
(i)Hairconditioners.
(ii)Hairsprays(aerosolfixatives).
(iii)Hairstraighteners.
(iv)Permanentwaves.
(v)Rinses(noncoloring).
(vi)Shampoos(noncoloring).
(vii)Tonics,dressings,andotherhairgroomingaids.
(viii)Wavesets.
(ix)Otherhairpreparations.
(6)Haircoloringpreparations.(i)Hairdyesandcolors(alltypes
requiringcautionstatementandpatchtest).
(ii)Hairtints.
(iii)Hairrinses(coloring).
(iv)Hairshampoos(coloring).
(v)Haircolorsprays(aerosol).
(vi)Hairlightenerswithcolor.
(vii)Hairbleaches.
(viii)Otherhaircoloringpreparations.
(7)Makeuppreparations(noteye).(i)Blushers(alltypes).
(ii)Facepowders.
(iii)Foundations.
(iv)Legandbodypaints.
(v)Lipstick.
(vi)Makeupbases.
(vii)Rouges.
(viii)Makeupfixatives.
(ix)Othermakeuppreparations.
(8)Manicuringpreparations.(i)Basecoatsandundercoats.
(ii)Cuticlesofteners.
(iii)Nailcreamsandlotions.
(iv)Nailextenders.
(v)Nailpolishandenamel.
(vi)Nailpolishandenamelremovers.
(vii)Othermanicuringpreparations.
(9)Oralhygieneproducts.(i)Dentifrices(aerosol,liquid,pastes,
andpowders).
(ii)Mouthwashesandbreathfresheners(liquidsandsprays).
(iii)Otheroralhygieneproducts.
(10)Personalcleanliness.(i)Bathsoapsanddetergents.
(ii)Deodorants(underarm).
(iii)Douches.
(iv)Femininehygienedeodorants.
(v)Otherpersonalcleanlinessproducts.
(11)Shavingpreparations.(i)Aftershavelotions.
(ii)Beardsofteners.
(iii)Men'
stalcum.
(iv)Preshavelotions(alltypes).
(v)Shavingcream(aerosol,brushless,andlather).
(vi)Shavingsoap(cakes,sticks,etc.).
(vii)Othershavingpreparationproducts.
(12)Skincarepreparations,(creams,lotions,powder,andsprays).
(i)Cleansing(coldcreams,cleansinglotions,liquids,andpads).
[[Page148]]
(ii)Depilatories.
(iii)Faceandneck(excludingshavingpreparations).
(iv)Bodyandhand(excludingshavingpreparations).
(v)Footpowdersandsprays.
(vi)Moisturizing.
(vii)Night.
(viii)Pastemasks(mudpacks).
(ix)Skinfresheners.
(x)Otherskincarepreparations.
(13)Suntanpreparations.(i)Suntangels,creams,andliquids.
(ii)Indoortanningpreparations.
(iii)Othersuntanpreparations.
(d)Ingredientsintheproductshouldbelistedasfollows:
(1)Alistofeachingredientofthecosmeticproductindescending
orderofpredominancebyweight(exceptthatthefragranceand/orflavor
maybedesignatedassuchwithoutnamingeachindividualingredientwhen
themanufacturerorsupplierofthefragranceand/orflavorrefusesto
discloseingredientdata).
(2)AningredientshouldbelistedbythenameadoptedbytheFood
andDrugAdministration(FDA)fortheingredientpursuantto
Sec.701.3(c)ofthischapter.
(3)IntheabsenceofanameadoptedbyFDApursuantto
Sec.701.3(c)ofthischapter,itscommonorusualname,ifithasone,
oritschemicalortechnicalnameshouldbelisted.
(4)Ifaningredientisamixture,eachingredientofthemixture
shouldbelistedinaccordancewithparagraphs(d)
(2)and(d)(3)ofthis
section,unlesssuchmixtureisaformulationvoluntarilyregisteredon
FormFDA2512,inwhichcasesuchmixtureshouldbeidentifiedas
``fragrance,'
``flavor,'
``fragranceandflavor'
or``base
formulation,'
asappropriate,andbystatingitsFDA-assignedcosmetic
productingredientstatementnumber.
(5)Whenthemanufacturerorsupplierofafragranceand/orflavor
refusestodiscloseingredientdata,thefragranceand/orflavorshould
belistedassuch.Thenonconfidentiallistingoftheproductnameand/
ortradenameornameofthemanufacturerorsupplierofeach
proprietaryfragranceand/orflavormixtureisoptional.
(e)AseparateFormFDA-2512shouldbefiledforeachdifferent
formulationofacosmeticproduct.However,exceptforthehaircoloring
preparationslistedinparagraph(c)(6)ofthissectionforwhicha
statementforeachshadeofsuchproductisrequired,asingleFormFDA-
2512maybefiledfortwoormoreshadesofacosmetic
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