NDC Code(s) : 49527-051-01, 49527-051-02, 49527-051-03, 49527-051-04, 49527-051-05
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATIONavobenzone and octisalate CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-051
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)(UNII: T9296U138P)
OCTYLDODECYL NEOPENTANOATE(UNII: X8725R883T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MYRISTYL MYRISTATE(UNII: 4042ZC00DY)
CETYL ESTERS WAX(UNII: D072FFP9GU)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
BLUEFISH(UNII: 79U8P8X3Q5)
CENTAURIUM ERYTHRAEA(UNII: 57X4TSH58S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CAFFEINE(UNII: 3G6A5W338E)
NYLON-12(UNII: 446U8J075B)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
SUCROSE(UNII: C151H8M554)
BIOTIN(UNII: 6SO6U10H04)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
MYRISTYL LAURATE(UNII: 58U0NZN2BT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
AMINOPROPYL ASCORBYL PHOSPHATE(UNII: 290O2PQ83R)
SOYBEAN(UNII: L7HT8F1ZOD)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARETH-21(UNII: 53J3F32P58)
DIMETHICONE(UNII: 92RU3N3Y1O)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
TRISILOXANE(UNII: 9G1ZW13R0G)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
MYRISTYL ALCOHOL(UNII: V42034O9PU)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
DOCOSANOL(UNII: 9G1OE216XY)
SIGESBECKIA ORIENTALIS WHOLE(UNII: ZM9Q0FEI4Z)
AGAR, UNSPECIFIED(UNII: 89T13OHQ2B)
WHEY PROTEIN HYDROLYSATE(UNII: 237DZG2JLA)
SACCHAROMYCES CEREVISIAE(UNII: 978D8U419H)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
HYDROXYETHYL CELLULOSE, UNSPECIFIED(UNII: T4V6TWG28D)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-051-011 in 1 CARTON 10/01/2015
150 mL in 1 JAR Type 0: Not a Combination Product
2NDC:49527-051-021 in 1 CARTON 07/12/2022
275 mL in 1 JAR Type 0: Not a Combination Product
3NDC:49527-051-031 in 1 CARTON 07/12/2022
315 mL in 1 JAR Type 0: Not a Combination Product
4NDC:49527-051-047 mL in 1 PACKET Type 0: Not a Combination Product07/12/2022
5NDC:49527-051-051 in 1 CARTON 10/01/2015
57 mL in 1 JAR Type 0: Not a Combination Product07/12/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 10/01/2015

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics Ltd. 202952982 manufacture(49527-051)

Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics Ltd. 204132062 pack(49527-051), label(49527-051)

Establishment
Name Address ID/FEI Business Operations
The Estee Lauder Inc 802599436 manufacture(49527-051), pack(49527-051), label(49527-051)

Establishment
Name Address ID/FEI Business Operations
Northtec LLC 943871157 pack(49527-051), label(49527-051)

Establishment
Name Address ID/FEI Business Operations
NORTHTEC KEYSTONE 949264774 pack(49527-051), label(49527-051)

Establishment
Name Address ID/FEI Business Operations
PALC 078364654 pack(49527-051), label(49527-051)

PRINCIPAL DISPLAY PANEL

de-aging

CLINIQUE
clinique smart
broad spectrum SPF 15
custom-repair moisturizer

DRY COMBINATION
POIDS NET WT. 2.5 OZ./75 ml ℮

PRINCIPAL DISPLAY PANEL - 75 ml Jar Carton