CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE- titanium dioxide and zinc oxide lotion 
CLINIQUE LABORATORIES LLC

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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CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE

Drug Facts

Active ingredients

Titanium Dioxide 6.3%

Zinc Oxide 4.0%

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•dimethicone•butyloctyl salicylate•polydiethylsiloxane•c12-15 alkyl benzoate•isononyl isononanoate•diethylhexyl succinate•neopentyl glycol diheptanoate•methyl trimethicone•butylene glycol•ethylhexyl methoxycrylene•lauryl peg-9 polydimethylsiloxyethyl dimethicone•silica•dipentaerythrityl tri-polyhydroxystearate•laureth-4•cetyl peg/ppg-10/1 dimethicone•dimethicone/peg-10/15 crosspolymer•dimethicone silylate•hydrolyzed wheat protein/pvp crosspolymer•triethoxycaprylylsilane•dimethicone crosspolymer-3•isostearic acid•caprylyl glycol•polyhydroxystearic acid•dipropylene glycol•phenoxyethanol•iron oxides (ci 77492)•iron oxides (ci 77491) [iln41953]

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CLINIQUE

broad
spectrum
SPF 50

UVA
UVB
invisible shield
technology

mineral
sunscreen fluid
for face

sensitive skin formula

1 FL.OZ.
30 ml e

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-752
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE63 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
LAURETH-4 (UNII: 6HQ855798J)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-752-011 in 1 CARTON06/01/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/01/2016
Labeler - CLINIQUE LABORATORIES LLC (044475127)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
PALC078364654pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture(49527-752) , pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture(49527-752) , pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
The Estee Lauder Inc802599436manufacture(49527-752) , pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
Northtec LLC943871157pack(49527-752) , label(49527-752)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774pack(49527-752) , label(49527-752)

Revised: 1/2023
Document Id: f1e9db9c-d185-21da-e053-2a95a90acf90
Set id: 58338786-82a7-45ae-930f-dcb2c70aa5cd
Version: 8
Effective Time: 20230110
 
CLINIQUE LABORATORIES LLC