TRACELESS SKIN RESPONSIVE TINT- octinoxate cream 
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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ACTIVE INGREDIENT: OCTISALATE 2%

WATER [] PHENYL TRIMETHICONE [] SILICA [] DIMETHICONE [] CETYL DIMETHICONE [] BUTYLENE GLYCOL [] POLYDECENE [] GLYCERYL DILAURATE [] ISOSTEARIC ACID [] CERAMIDE 2 [] SODIUM HYALURONATE [] ACETYL HEXAPEPTIDE-8 [] CAFFEINE [] SUCROSE [] HYDROGENATED LECITHIN [] TOCOPHERYL ACETATE [] CHOLESTEROL [] LINOLEIC ACID [] PEG-9 DIMETHICONE [] STEARETH-21 [] STEARETH-2 [] STEARIC ACID [] CITRUS AURANTIUM DULCIS (ORANGE) [] METHYLDIHYDROJASMONATE [] DIMETHYL OCTENOL [] PHENETHYL ALCOHOL [] FLORALOZONE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] MAGNESIUM ALUMINUM SILICATE [] CELLULOSE GUM [] XANTHAN GUM [] TROMETHAMINE [] TETRASODIUM EDTA [] BHT [] PHENOXYETHANOL [] CHLOROXYLENOL []  [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL:

PRESCRIPTIVES

TRACELESS
SKIN RESPONSIVE TINT


1 FL OZ./ 30 ML


PRESCIPTIVES DISTR

NY,NY 10022

FOLDING CARTON


TRACELESS  SKIN RESPONSIVE TINT
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-731
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CAFFEINE (UNII: 3G6A5W338E)  
SUCROSE (UNII: C151H8M554)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59158-731-011 in 1 CARTON
1NDC:59158-731-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2001
Labeler - PRESCRIPTIVES INC. (151701588)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 4/2011
Document Id: 292b6d23-8e51-4a64-964c-cf1b49b45530
Set id: 783bad5b-8cf4-4c23-92b5-bda2181328d1
Version: 2
Effective Time: 20110405
 
PRESCRIPTIVES INC.