Medication Guide App

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25

Dosage form: paste
Ingredients: TITANIUM DIOXIDE 4.2g in 100g
Labeler: PRESCRIPTIVES INC
NDC Code: 59158-914

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.

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

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-914
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOCETYL MYRISTATE 
DIISOSTEARYL MALATE 
CARNAUBA WAX 
CANDELILLA WAX 
HIGH DENSITY POLYETHYLENE 
SOYBEAN OIL 
.ALPHA.-TOCOPHEROL ACETATE 
ISOPROPYL TITANIUM TRIISOSTEARATE 
ROSEMARY 
PHYTOSPHINGOSINE 
SANTALUM ALBUM SEED 
HYDROGENATED COTTONSEED OIL 
SILICON DIOXIDE 
DIMETHICONE 
ALUMINUM OXIDE 
STANNIC OXIDE 
BUTYLATED HYDROXYTOLUENE 
MICA 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:59158-914-011 CONTAINER (CONTAINER) 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/FEIOperations
ELGC K.K.712808195RELABEL(59158-914), REPACK(59158-914)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59158-914), RELABEL(59158-914), REPACK(59158-914)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59158-914), RELABEL(59158-914)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(59158-914), RELABEL(59158-914), REPACK(59158-914)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(59158-914), RELABEL(59158-914), REPACK(59158-914)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(59158-914), RELABEL(59158-914), REPACK(59158-914)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(59158-914)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(59158-914), RELABEL(59158-914)
Establishment
NameAddressID/FEIOperations
Toshiki Pigment Company Limited690723812MANUFACTURE(59158-914)

Revised: 09/2012
 
PRESCRIPTIVES INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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