CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50- octinoxate, titanium dioxide, and zinc oxide lotion

CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 5.0%
Titanium Dioxide 3.2%
Zinc Oxide 3.6%

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:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m –2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eaudimethiconebutyloctyl salicylateisononyl isononanoateneopentyl glycol diheptanoatelauryl peg-9 polydimethylsiloxyethyl dimethiconebutylene glycolpolydecenepolyhydroxystearic acidethylhexyl methoxycrylenehydrated silicadimethicone/vinyl dimethicone crosspolymertrimethylsiloxysilicatehydrolyzed wheat protein/pvp crosspolymerhydroxyapatitecetyl peg/ppg-10/1 dimethiconedimethicone/peg-10/15 crosspolymersodium rnaquaternium-90 bentonitesodium hyaluronatedimethicone crosspolymer-3styrene/acrylates copolymersodium chloridecaprylyl glycolpeg-8 lauratepropylene carbonatesilicatocopherolsodium citratedisodium edtabhtphenoxyethanolpotassium sorbateiron oxides (ci 77491)iron oxides (ci 77492) [iln47235]

Other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

sun protection

SUPERDEFENSE
CITY BLOCK

daily energy + face protector

BROAD
SPECTRUM
SPF 50

CLINIQUE

1.4 FL.OZ.LIQ./
40 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50 
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE 100 (UNII: RO266O364U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
1,2-BUTANEDIOL (UNII: RUN0H01QEU)
HYDROGENATED DIDECENE (UNII: 048B98MT5O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)
SODIUM CARBONATE (UNII: 45P3261C7T)
BENTONITE (UNII: A3N5ZCN45C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-8 LAURATE (UNII: 762O8IWA10)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-078-01	1 in 1 CARTON	06/25/2020
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/25/2020

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-078) , pack(49527-078) , label(49527-078)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	pack(49527-078) , label(49527-078)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	label(49527-078) , pack(49527-078)