NDC Code(s) : 57627-158-01, 57627-158-02
Packager : Merle Norman

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Preventage Hand Treatment Broad Spectrum SPF 15 Avobenzone, Octocrylene CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57627-158
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.9 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE9.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
STEARIC ACID(UNII: 4ELV7Z65AP)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYACRYLAMIDE (1500 MW)(UNII: 5D6TC4BRWV)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ASIAN GINSENG(UNII: CUQ3A77YXI)
CHAMOMILE(UNII: FGL3685T2X)
CUCUMBER(UNII: YY7C30VXJT)
ECHINACEA PURPUREA(UNII: QI7G114Y98)
EQUISETUM ARVENSE BRANCH(UNII: 1L0VKZ185E)
FENNEL SEED(UNII: G3QC02NIE6)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GINKGO(UNII: 19FUJ2C58T)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CYCLOMETHICONE(UNII: NMQ347994Z)
CYCLOMETHICONE 4(UNII: CZ227117JE)
LEVOMENOL(UNII: 24WE03BX2T)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
POLYGLYCERYL-10 DECAOLEATE(UNII: NJR3XZA3NW)
POLYGLYCERYL-10 OLEATE(UNII: 55C81W76DH)
TRILAURETH-4 PHOSPHATE(UNII: M96W2OLL2V)
POLYGLYCERYL-6 DISTEARATE(UNII: Z35I17EQOP)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE(UNII: 7D4Q5YJ8NV)
TROLAMINE(UNII: 9O3K93S3TK)
SORBITOL(UNII: 506T60A25R)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
LAURETH-7(UNII: Z95S6G8201)
EDETATE TRISODIUM(UNII: 420IP921MB)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CHLORPHENESIN(UNII: I670DAL4SZ)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57627-158-021 in 1 CARTON 02/05/2013
1NDC:57627-158-01113 g 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 05/02/2013

PRINCIPAL DISPLAY PANEL

carton

carton

Preventage Hand Treatment SPF 15

Merle Norman

established in Los Angeles since 1931

113g Net Wt. 4 Oz.