FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25- titanium dioxide paste 
PRESCRIPTIVES INC

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.

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FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25

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>

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
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)

Revised: 9/2012
Document Id: ec997f74-4a04-4f65-b9fa-dc00edba452d
Set id: cc4e3809-cf43-457d-bea2-3ff474e2723b
Version: 1
Effective Time: 20120911
 
PRESCRIPTIVES INC