TRACELESS SKIN RESPONSIVE TINT- octinoxate cream

TRACELESS by

Drug Labeling and Warnings

TRACELESS by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES INC., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: OCTISALATE 2%

INACTIVE INGREDIENT

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)

WARNINGS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

PRESCRIPTIVES

TRACELESS
SKIN RESPONSIVE TINT


1 FL OZ./ 30 ML

PRESCIPTIVES DISTR

NY,NY 10022

INGREDIENTS AND APPEARANCE

TRACELESS  SKIN RESPONSIVE TINT
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59158-731-01	1 in 1 CARTON
1	NDC: 59158-731-02	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2001

Labeler - PRESCRIPTIVES INC. (151701588)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture