NDC Code(s) : 68026-203-30, 68026-203-01
Packager : La Prairie, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cellular Swiss Ice Crystal Transforming Cream SPF 30 - BeigeOctinoxate 7.5% Zinc Oxide 7.4% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68026-203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE74 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL(UNII: E107L85C40)
ISODODECANE(UNII: A8289P68Y2)
GLYCOPROTEIN HORMONES ALPHA CHAIN(UNII: 8YJ68CQ409)
ASIAN GINSENG(UNII: CUQ3A77YXI)
XANTHAN GUM(UNII: TTV12P4NEE)
BELLIS PERENNIS FLOWER(UNII: 26I94X9A1K)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
METHICONE (20 CST)(UNII: 6777U11MKT)
ISOMALT(UNII: S870P55O2W)
ALUMINUM OXIDE(UNII: LMI26O6933)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
PSEUDEVERNIA FURFURACEA(UNII: 49ZMN09Q0K)
TOCOPHEROL(UNII: R0ZB2556P8)
HYDROXYCITRONELLAL(UNII: 8SQ0VA4YUR)
GERANIOL(UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MICA(UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
WATER(UNII: 059QF0KO0R)
LENTIL(UNII: 6O38V6B52O)
PANTHENOL(UNII: WV9CM0O67Z)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
SACCHAROMYCES CEREVISIAE(UNII: 978D8U419H)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
LACTIC ACID(UNII: 33X04XA5AT)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
EQUISETUM ARVENSE BRANCH(UNII: 1L0VKZ185E)
MAGNESIUM SULFATE(UNII: DE08037SAB)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
STANNIC OXIDE(UNII: KM7N50LOS6)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
BENZYL BENZOATE(UNII: N863NB338G)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
EUGENOL(UNII: 3T8H1794QW)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68026-203-3030 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product04/01/2016
2NDC:68026-203-011 mL in 1 PACKET Type 0: Not a Combination Product04/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/01/2016

PRINCIPAL DISPLAY PANEL

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