NDC Code(s) : 58668-2261-1
Packager : Laboratoires Clarins S.A.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 116 TITANIUM DIOXIDE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58668-2261
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ISODODECANE(UNII: A8289P68Y2)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
NYLON-12(UNII: 446U8J075B)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
MAGNESIUM SULFATE(UNII: DE08037SAB)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
POLYGLYCERYL-3 DIISOSTEARATE(UNII: 46P231IQV8)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYDROXYETHYL UREA(UNII: MBQ7DDQ7AR)
SORBIC ACID(UNII: X045WJ989B)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ACACIA(UNII: 5C5403N26O)
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
1NDC:58668-2261-11 in 1 PACKAGE
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/08/2013

PRINCIPAL DISPLAY PANEL

CLARINS PARIS  116 Teint Haute Tenue Broad Spectrum SPF 15 Titanium Dioxide - Sunscreen Everlasting Foundation e 30 mL 1.2 Oz. Net Wt.

PRINCIPAL DISPLAY PANEL

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