NDC Code(s) : 49817-0089-1
Packager : Guerlain

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ORCHIDEE IMPERIALE - EXCEPTIONAL COMPLETE CARE - THE UV BEAUTY PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 UNIVERSAL SHADEOCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49817-0089
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE74.9 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE20 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE67.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISODODECANE(UNII: A8289P68Y2)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
MAGNESIUM SULFATE(UNII: DE08037SAB)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
ALUMINUM OXIDE(UNII: LMI26O6933)
SODIUM MYRISTOYL GLUTAMATE(UNII: AYU7QD893W)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STEARYL GLYCYRRHETINATE(UNII: 3YYE6VJS0P)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
RAFFINOSE(UNII: N5O3QU595M)
MORINGA OLEIFERA SEED(UNII: TIX5482832)
MALVA SYLVESTRIS FLOWERING TOP(UNII: X1U1U0N90J)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
SANGUISORBA OFFICINALIS ROOT(UNII: 4NYV2HT01X)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
GERANIOL(UNII: L837108USY)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49817-0089-11 in 1 BOX
130 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/26/2014

PRINCIPAL DISPLAY PANEL

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