NDC Code(s) : 59899-001-01
Packager : Shaklee Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Enfuselle Time Repair A.M. SPF15HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59899-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE50 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE35 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
CETEARYL ETHYLHEXANOATE(UNII: 9M64UO4C25)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
PEG-100 STEARATE(UNII: YD01N1999R)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
PANTHENOL(UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FAGUS SYLVATICA FLOWER BUD(UNII: 6D5V13045W)
SAXIFRAGA STOLONIFERA LEAF(UNII: O3TMV4903H)
VITIS VINIFERA SEED(UNII: C34U15ICXA)
MORUS AUSTRALIS ROOT(UNII: 1VL55O45RF)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SOYBEAN(UNII: L7HT8F1ZOD)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ISOHEXADECANE(UNII: 918X1OUF1E)
XANTHAN GUM(UNII: TTV12P4NEE)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLYSORBATE 60(UNII: CAL22UVI4M)
EDETATE DISODIUM(UNII: 7FLD91C86K)
EDETATE SODIUM(UNII: MP1J8420LU)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59899-001-011 in 1 CARTON 07/08/2013
159 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/07/2013

PRINCIPAL DISPLAY PANEL

enfuselle®

by Shaklee

TIME REPAIR A.M.® CREAM

BROAD SPECTRUM
SPF 15 SUNSCREEN

PARABEN FREE

2 fl. oz. 59 mL

Not tested on animals
100% oil free
Broad spectrum SPF 15
Contains mulberry, beech tree bud, strawberry geranium, grape, licorice, and scutellaria extracts, and vitamins A, C, and E as skin-conditioning agents
Won't clog pores
100% fragrance, dye and paraben free
Allergy tested
Clinically formulated
Dermatologist tested
Shaklee
Dist. by/par Shaklee Corporation
4747 Willow Road, Pleasanton, CA 94588 USA
Imp. by/par Shaklee Canada Inc.
3100 Harvest Road, Unit 7, Burlington. ON L7N 3W8
Product questions: 925.734.3638
Item #32564

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Smooth onto face and neck in the A.M. 15 minutes before sun exposure.

CAUTION: Avoid contact with eyes. Discontinue use if skin irritation
develops or increases. Do not use on damaged or broken skin. If irritation
persists, consult a health care practitioner.

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