CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION- avobenzone and octisalate cream 
CLINIQUE LABORATORIES LLC

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CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION

Drug Facts

Active ingredients

Avobenzone 3.0%
Octisalate 5.0%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

water\aqua\eau • glycerin • butyloctyl salicylate • polyester-8 • octyldodecyl neopentanoate • behenyl alcohol • butylene glycol • myristyl myristate • cetyl esters • ammonium acryloyldimethyltaurate/vp copolymer • plankton extract • centaurium erythraea (centaury) extract • sigesbeckia orientalis (st. paul's wort) extract • glyceryl stearate • algae extract • caffeine • whey protein\lactis protein\protéine du petit-lait • nylon-12 • acetyl hexapeptide-8 • sucrose • biotin • ergothioneine • myristyl laurate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • polyethylene • aminopropyl ascorbyl phosphate • glycine soja (soybean) protein • peg-100 stearate • steareth-21 • saccharomyces/xylinum/black tea ferment • dimethicone • acetyl glucosamine • astrocaryum murumuru seed butter • trisiloxane • caprylyl glycol • tocopheryl acetate • myristyl alcohol • sodium hyaluronate • hexylene glycol • calcium chloride • hydroxyethylcellulose • sodium benzoate • citric acid • sodium citrate • lecithin • disodium edta • potassium sorbate • phenoxyethanol • yellow 5 (ci 19140) • red 4 (ci 14700) [iln49049]

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 75 ml Jar Carton

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
CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION 
avobenzone and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-051-011 in 1 CARTON10/01/2015
150 mL in 1 JAR; Type 0: Not a Combination Product
2NDC:49527-051-021 in 1 CARTON07/12/2022
275 mL in 1 JAR; Type 0: Not a Combination Product
3NDC:49527-051-031 in 1 CARTON07/12/2022
315 mL in 1 JAR; Type 0: Not a Combination Product
4NDC:49527-051-047 mL in 1 PACKET; Type 0: Not a Combination Product07/12/202210/05/2023
5NDC:49527-051-051 in 1 CARTON10/01/2015
57 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2015
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982manufacture(49527-051)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(49527-051) , label(49527-051)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(49527-051) , pack(49527-051) , label(49527-051)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(49527-051) , label(49527-051)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774pack(49527-051) , label(49527-051)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654pack(49527-051) , label(49527-051)

Revised: 12/2023
Document Id: 0d0dced8-4ba0-0cb3-e063-6394a90ad037
Set id: 228db004-3afa-479a-be38-8e4c4c959cb4
Version: 11
Effective Time: 20231221
 
CLINIQUE LABORATORIES LLC