CLINIQUE  MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25- octinoxate and titanium dioxide cream 
CLINIQUE LABORATORIES INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25

Drug Facts

Active ingredients

Octinoxate 5.5%
Titanium Dioxide 4.7%

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

isotridecyl isononanoate • dimethicone • squalane • dextrin palmitate • dimethicone/vinyl dimethicone crosspolymer • vinyl dimethicone/methicone silsesquioxane crosspolymer • talc • phytosteryl/octyldodecyl lauroyl glutamate • sorbitan sesquiisostearate • alumina • glycerin • salicylic acid • silica dimethyl silylate • tocopherol • sodium hyaluronate • nylon-12 • methyl methacrylate crosspolymer • hdi/trimethylol hexyllactone crosspolymer • stearic acid • triethoxycaprylylsilane • silica • magnesium myristate • tin oxide • dehydroacetic acid • [+/- titanium dioxide (ci 77891) • mica • iron oxides (ci 77499) • iron oxides (ci 77491) • iron oxides (ci 77492)] [iln40504]

Other information

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

PRINCIPAL DISPLAY PANEL - 10 g Tube Carton

C

CLINIQUE

moisture surge

cc
cream compact

hydrating colour corrector
broad spectrum SPF 25

POIDS NET WT. .35 OZ./10 g e

Principal Display Panel - 10 g Tube Carton
CLINIQUE   MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SQUALANE (UNII: GW89575KF9)  
TALC (UNII: 7SEV7J4R1U)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
NYLON-12 (UNII: 446U8J075B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
MICA (UNII: V8A1AW0880)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-040-011 in 1 CARTON
110 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/01/2013
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(49527-040) , REPACK(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(49527-040) , RELABEL(49527-040)
Establishment
NameAddressID/FEIBusiness Operations
NIPPON SHIKIZAI692572936MANUFACTURE(49527-040)

Revised: 1/2014
Document Id: 89519e46-d9ca-47ba-b53f-6692d53d59ba
Set id: 0978e6ea-adb2-43f4-aae3-e1cb620e48e8
Version: 1
Effective Time: 20140106
 
CLINIQUE LABORATORIES INC.