FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25- titanium dioxide paste

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 by

Drug Labeling and Warnings

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center, Toshiki Pigment Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-914
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59158-914-01	1 in 1 CARTON
1		3.5 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2005

Labeler - PRESCRIPTIVES INC (151701588)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(59158-914) , REPACK(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(59158-914) , RELABEL(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(59158-914) , RELABEL(59158-914) , REPACK(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(59158-914) , RELABEL(59158-914)

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Company Limited		690723812	MANUFACTURE(59158-914)