NDC Code(s) : 49817-0078-1
Packager : Guerlain

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHTOCTINOXATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49817-0078
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
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE38.4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SQUALANE(UNII: GW89575KF9)
PROPANEDIOL(UNII: 5965N8W85T)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
ETHYLHEXYL ISONONANOATE(UNII: I6KB4GE3K4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
DICAPRYLYL ETHER(UNII: 77JZM5516Z)
STEARIC ACID(UNII: 4ELV7Z65AP)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALUMINUM OXIDE(UNII: LMI26O6933)
XYLOSE(UNII: A1TA934AKO)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
POLYGLYCERYL-10 STEARATE(UNII: 90TF85HH91)
EDETATE DISODIUM(UNII: 7FLD91C86K)
RUSCUS ACULEATUS ROOT(UNII: ZW12V95I1Q)
VIOLA TRICOLOR(UNII: 9Q24RAI43V)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
GERANIOL(UNII: L837108USY)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TOCOPHEROL(UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49817-0078-11 in 1 CARTON
140 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 04/10/2014

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