CLINIQUE EVEN BETTER SKIN TONE CORRECTING BROAD SPECTRUM SPF 20- octisalate, avobenzone, and octocrylene lotion

CLINIQUE by

Drug Labeling and Warnings

CLINIQUE 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

Octisalate 5.0%
Avobenzone 3.0%
Octocrylene 2.7%

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:

• 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 dimethicone yeast extract butyloctyl salicylate peg-100 stearate trisiloxane butylene glycol hdi/trimethylol hexyllactone crosspolymer ascorbyl glucoside coco-caprylate/caprate polyethylene glyceryl stearate peg-6 glycerin olea europaea (olive) fruit extract citrus grandis (grapefruit) peel extract triticum vulgare (wheat bran) extract laminaria saccharina extract trametes versicolor extract cucumis sativus (cucumber) fruit extract pyrus malus (apple) fruit extract scutellaria baicalensis root extract punica granatum (pomegranate) fruit juice oryza sativa (rice) bran extract salicylic acid caffeine linoleic acid cholesterol acetyl glucosamine sodium rna dipotassium glycyrrhizate steareth-21 sucrose tromethamine di-c12-18 alkyl dimonium chloride sodium hyaluronate cetyl alcohol ammonium acryloyldimethyltaurate/vp copolymer lauryl peg-9 polydimethylsiloxyethyl dimethicone caprylyl glycol dimethiconol trehalose tocopheryl acetate hexylene glycol silica sodium hydroxide xanthan gum disodium edta phenoxyethanol [iln38585]

Other information

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

SPL UNCLASSIFIED SECTION

© CLINIQUE LABS., DIST. N.Y., N.Y. 10022
N.Y., LONDON W1K 3BQ PARIS

PRINCIPAL DISPLAY PANEL - 50 ml Carton

CLINIQUE

even better

skin tone
correcting lotion
broad spectrum
SPF 20

COMBINATION OILY TO OILY

1.7 FL.OZ.LIQ./50 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE   EVEN BETTER SKIN TONE CORRECTING BROAD SPECTRUM SPF 20
octisalate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PEG-100 STEARATE (UNII: YD01N1999R)
TRISILOXANE (UNII: 9G1ZW13R0G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
BLACK OLIVE (UNII: 2M6QWV94OC)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
WHEAT BRAN (UNII: 6L966A1IMR)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CUCUMBER (UNII: YY7C30VXJT)
APPLE (UNII: B423VGH5S9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
POMEGRANATE JUICE (UNII: 99S671U9KB)
RICE BRAN (UNII: R60QEP13IC)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAFFEINE (UNII: 3G6A5W338E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STEARETH-21 (UNII: 53J3F32P58)
SUCROSE (UNII: C151H8M554)
TROMETHAMINE (UNII: 023C2WHX2V)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETYL ALCOHOL (UNII: 936JST6JCN)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-112-01	1 in 1 CARTON	11/01/2011
1		50 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 NOT FINAL	part352	11/01/2011

Labeler - Clinique Laboratories LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-112) , REPACK(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-112) , REPACK(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-112) , REPACK(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-112)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-112)