NDC Code(s) : 34022-102-02, 34022-102-12
Packager : MOSAIC MARKETING PARTNERS LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DAY CREAM REPLENISHING HYDRATOR OCTINOXATE AVOBENZONE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:34022-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6.6 g in 100 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLYSILICONE-15(UNII: F8DRP5BB29)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETIDRONIC ACID(UNII: M2F465ROXU)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCINE(UNII: TE7660XO1C)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
TRIDECETH-10(UNII: G624N6MSBA)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GLYCERIN(UNII: PDC6A3C0OX)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
PANTHENOL(UNII: WV9CM0O67Z)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
STEARIC ACID(UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GUAR GUM(UNII: E89I1637KE)
PROLINE(UNII: 9DLQ4CIU6V)
ALANINE(UNII: OF5P57N2ZX)
OENOTHERA BIENNIS(UNII: 76UI55V071)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
RUSCUS ACULEATUS ROOT(UNII: ZW12V95I1Q)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
AESCULUS HIPPOCASTANUM LEAF(UNII: Z49U891FNQ)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
VITIS VINIFERA SEED(UNII: C34U15ICXA)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ALLANTOIN(UNII: 344S277G0Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:34022-102-121 in 1 BOX
1NDC:34022-102-0250 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/21/2012

PRINCIPAL DISPLAY PANEL

DAY CREAM

REPLENISHING HYDRATOR

SPF 25


6100050_DayCreamReplenis_Bottle6100050_DayCreamReplenis_Bottle