NDC Code(s) : 54181-001-50
Packager : Guinot SAS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GUINOT Skin Defense SPF 15 Face OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54181-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE40 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE11 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ADENINE(UNII: JAC85A2161)
ADENOSINE(UNII: K72T3FS567)
ADENOSINE PHOSPHATE(UNII: 415SHH325A)
ADENOSINE TRIPHOSPHATE(UNII: 8L70Q75FXE)
ALANINE(UNII: OF5P57N2ZX)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
CHAMAEMELUM NOBILE FLOWER OIL(UNII: UB27587839)
ARGININE(UNII: 94ZLA3W45F)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ASPARTIC ACID(UNII: 30KYC7MIAI)
BETAINE(UNII: 3SCV180C9W)
BIOTIN(UNII: 6SO6U10H04)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SHEANUT OIL(UNII: O88E196QRF)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
CAPRYLOYL GLYCINE(UNII: 8TY5YO42NJ)
CERAMIDE 2(UNII: C04977SRJ5)
CETYL ALCOHOL(UNII: 936JST6JCN)
CHOLESTEROL(UNII: 97C5T2UQ7J)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
LEMON OIL(UNII: I9GRO824LL)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYSTEINE(UNII: K848JZ4886)
CYTOSINE(UNII: 8J337D1HZY)
DIETHYLHEXYL CARBONATE(UNII: YCD50O0Z6L)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BACILLUS POLYFERMENTICUS(UNII: 6UQO3086C7)
ETHYL LINOLEATE(UNII: MJ2YTT4J8M)
ETHYL LINOLENATE(UNII: T54Y8H042V)
ETHYL OLEATE(UNII: Z2Z439864Y)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FOLIC ACID(UNII: 935E97BOY8)
DEXTROSE(UNII: IY9XDZ35W2)
GLUTAMIC ACID(UNII: 3KX376GY7L)
GLUTAMINE(UNII: 0RH81L854J)
GLUTATHIONE(UNII: GAN16C9B8O)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
GLYCINE(UNII: TE7660XO1C)
GUANINE(UNII: 5Z93L87A1R)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
HISTIDINE(UNII: 4QD397987E)
HYDROXYCITRONELLAL(UNII: 8SQ0VA4YUR)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE(UNII: QUE43B9Z2Q)
HYDROXYPROLINE(UNII: RMB44WO89X)
INOSITOL(UNII: 4L6452S749)
ISOLEUCINE(UNII: 04Y7590D77)
LAVANDIN OIL(UNII: 9RES347CKG)
LEUCINE(UNII: GMW67QNF9C)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
LYSINE HYDROCHLORIDE(UNII: JNJ23Q2COM)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
MAGNESIUM SULFATE(UNII: DE08037SAB)
METHIONINE(UNII: AE28F7PNPL)
NIACIN(UNII: 2679MF687A)
NIACINAMIDE(UNII: 25X51I8RD4)
PALMITIC ACID(UNII: 2V16EO95H1)
PECTIN(UNII: 89NA02M4RX)
PEG-100 STEARATE(UNII: YD01N1999R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENYLALANINE(UNII: 47E5O17Y3R)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM ASPARTATE(UNII: OC4598NZEQ)
POTASSIUM CHLORIDE(UNII: 660YQ98I10)
POTASSIUM NITRATE(UNII: RU45X2JN0Z)
PROLINE(UNII: 9DLQ4CIU6V)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
RIBOFLAVIN(UNII: TLM2976OFR)
RIBOSE, D-(UNII: 681HV46001)
SACCHAROMYCES CEREVISIAE RNA(UNII: J17GBZ5VGX)
SARCOSINE(UNII: Z711V88R5F)
SERINE(UNII: 452VLY9402)
SODIUM ACETATE(UNII: 4550K0SC9B)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SODIUM PHOSPHATE(UNII: SE337SVY37)
SODIUM SULFATE(UNII: 0YPR65R21J)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
THIAMINE HYDROCHLORIDE(UNII: M572600E5P)
THREONINE(UNII: 2ZD004190S)
THYMIDINE(UNII: VC2W18DGKR)
THYMINE(UNII: QR26YLT7LT)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
TRIMETHOXYCAPRYLYLSILANE(UNII: FZ07E4LW2M)
TRYPTOPHAN(UNII: 8DUH1N11BX)
TYROSINE(UNII: 42HK56048U)
URACIL(UNII: 56HH86ZVCT)
VALINE(UNII: HG18B9YRS7)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
XANTHINE(UNII: 1AVZ07U9S7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54181-001-501 in 1 PACKAGE
150 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/11/2013

PRINCIPAL DISPLAY PANEL

GuiNot  INSTITUT • PARIS
Douceur DE VIE SKIN DEFENSE SPF 15
FACE CREAM • REINFORCES SKIN'S NATURAL DEFENSES
DE-STRESSING ESSENTIAL OILS

e 50 ml  NET WT 1.5 OZ

PRINCIPAL DISPLAY PANEL

Skin Defense