Label: FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25- titanium dioxide paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 11, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • Usage

    Apply before sun exposure.

  • WARNING

    Keep out of eyes.

    Stop use if irritation occurs.

    Keep out of reach of children.

  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE 4.20%

  • INGREDIENTS

    ISOCETYL MYRISTATE • METHYL METHACRYLATE CROSSPOLYMER • DIISOSTEARYL MALATE • COPERNICIA CERIFERA (CARNAUBA) WAX\CERA CARNAUBA\CIRE DE CARNAUBA • POLYGLYCERYL-2 OLEATE • EUPHORBIA CERIFERA (CANDELILLA) WAX\CANDELILLA CERA\CIRE DE CANDELILLA • POLYETHYLENE • GLYCINE SOJA (SOYBEAN) OIL • TOCOPHERYL ACETATE • PORIA COCOS SCLEROTIUM EXTRACT • ISOPROPYL TITANIUM TRIISOSTEARATE • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • SODIUM RNA • PHYTOSPHINGOSINE • SANTALUM ALBUM SEED EXTRACT • HYDROGENATED COTTONSEED OIL • ALLYL METHACRYLATES CROSSPOLYMER • SILICA • DIMETHICONE • DIMETHICONE SILYLATE • ALUMINA • TIN OXIDE • BHT • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77491, CI 77492, CI 77499)] <ILN33642>

  • SPL UNCLASSIFIED SECTION

    PRESCRIPTIVES CO., DIST.
    NEW YORK, N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 3.5g Container Carton

    PX
    PRESCRIPTIVES

    Flawless Skin

    Total Protection Concealer
    UVA/UVB SPF 25

    Net Wt./Poids Net . 11 Oz. / 3.5g e

    PRINCIPAL DISPLAY PANEL - 3.5g Container Carton
  • INGREDIENTS AND APPEARANCE
    FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 
    titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-914
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOCETYL MYRISTATE (UNII: 69AX3BRR5N)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    ROSEMARY (UNII: IJ67X351P9)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SANTALUM ALBUM SEED (UNII: 7RZT0U509Y)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59158-914-011 in 1 CARTON
    13.5 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/01/2005
    Labeler - PRESCRIPTIVES INC (151701588)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(59158-914) , REPACK(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59158-914) , RELABEL(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(59158-914) , RELABEL(59158-914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toshiki Pigment Company Limited690723812MANUFACTURE(59158-914)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!