NDC Code(s) : 68828-132-01, 68828-132-02
Packager : JAFRA COSMETICS INTERNATIONAL

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Broad Spectrum SPF 15 Daily Eye Treat Avobenzone, Homosalate, Octisalate, Octoorylene CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68828-132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2.5 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1.75 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
FRAXINUS EXCELSIOR BARK(UNII: R6KCX5H8I2)
SILANETRIOL(UNII: E52D0J3TS5)
POTASSIUM CITRATE(UNII: EE90ONI6FF)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
SQUALANE(UNII: GW89575KF9)
POLYSORBATE 60(UNII: CAL22UVI4M)
POLYACRYLAMIDE (1500 MW)(UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
LAURETH-7(UNII: Z95S6G8201)
LAMINARIA OCHROLEUCA(UNII: 4R2124HE76)
PANTHENOL(UNII: WV9CM0O67Z)
GLYCERIN(UNII: PDC6A3C0OX)
LEVOMENOL(UNII: 24WE03BX2T)
DMDM HYDANTOIN(UNII: BYR0546TOW)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PEG-4 LAURATE(UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
EDETATE TRISODIUM(UNII: 420IP921MB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68828-132-021 in 1 CARTON
1NDC:68828-132-0115 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/08/2013

PRINCIPAL DISPLAY PANEL

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Jafra Beauty Dynamics

Broad Spectrum SPF 15 Daily Eye Treat +

Cont. Net. 15 ml .5 fl oz (US)