NDC Code(s) : 58668-2831-1
Packager : Laboratoires Clarins S.A

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLARINS Ever Matte Broad Spectrum SPF 15 Tint 109TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58668-2831
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 DIOXIDE23 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
MAGNESIUM SULFATE, UNSPECIFIED(UNII: DE08037SAB)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERIN(UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
LIMONIA ACIDISSIMA WOOD(UNII: 04X926XD7Z)
METHYL METHACRYLATE(UNII: 196OC77688)
POLYETHYLENE GLYCOL 500(UNII: 761NX2Q08Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE(UNII: 92RU3N3Y1O)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
HECTORITE(UNII: 08X4KI73EZ)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
DIMETHICONOL (250000 MW)(UNII: RKI3S914RT)
HYDROXYETHYL UREA(UNII: MBQ7DDQ7AR)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LAPSANA COMMUNIS FLOWERING TOP(UNII: T9B77O7PZA)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
ACACIA(UNII: 5C5403N26O)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CHRYSIN(UNII: 3CN01F5ZJ5)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MICA(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58668-2831-11 in 1 PACKAGE
130 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/11/2012

PRINCIPAL DISPLAY PANEL


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