EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20- avobenzone, octisalate, and octocrylene cream

EVEN BETTER SKIN TONE CORRECTING MOISTURIZER by

Drug Labeling and Warnings

EVEN BETTER SKIN TONE CORRECTING MOISTURIZER 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

Avobenzone 3.0%
Octisalate 5.0%
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\aqua\eau butyloctyl salicylate nylon-12 octyldodecyl neopentanoate behenyl alcohol myristyl myristate saccharomyces cerevisiae extract ascorbyl glucoside cetyl esters butylene glycol polyethylene ammonium acryloyldimethyltaurate/vp copolymer yeast extract\faex\extrait de levure betula alba (birch) bark extract cucumis sativus (cucumber) fruit extract scutellaria baicalensis root extract pyrus malus (apple) fruit extract trametes versicolor extract triticum vulgare (wheat bran) extract saccharomyces lysate extract punica granatum (pomegranate) juice extract olea europaea (olive) fruit extract curcuma longa (turmeric) root extract oryza sativa (rice) bran extract citrus grandis (grapefruit) peel extract peg-6 cholesterol dimethicone glyceryl stearate peg-100 stearate glycerin di-ppg-2 myreth-10 adipate steareth-21 caffeine sodium rna cellulose acetyl glucosamine simethicone tromethamine sucrose di-c12-18 alkyl dimonium chloride salicylic acid sodium hyaluronate tocopheryl acetate trisiloxane linoleic acid caprylyl glycol sodium sulfite sodium metabisulfite magnesium ascorbyl phosphate betaine trehalose hexylene glycol dipotassium glycyrrhizate lauryl peg-9 polydimethylsiloxyethyl dimethicone disodium edta phenoxyethanol polyaminopropyl biguanide [iln35669]

Other information

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

SPL UNCLASSIFIED SECTION

CLINIQUE LABORATORIES, DIST. N.Y., N.Y. 10022
NEW YORK LONDON W1K 3BQ PARIS

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

CLINIQUE
even better

skin tone correcting moisturizer
broad spectrum SPF 20

VERY DRY TO DRY COMBINATION

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

EVEN BETTER SKIN TONE CORRECTING MOISTURIZER   BROAD SPECTRUM SPF 20
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0303 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.2727 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
nylon-12 (UNII: 446U8J075B)
octyldodecyl neopentanoate (UNII: X8725R883T)
docosanol (UNII: 9G1OE216XY)
myristyl myristate (UNII: 4042ZC00DY)
saccharomyces cerevisiae (UNII: 978D8U419H)
ascorbyl glucoside (UNII: 2V52R0NHXW)
cetyl esters wax (UNII: D072FFP9GU)
butylene glycol (UNII: 3XUS85K0RA)
high density polyethylene (UNII: UG00KM4WR7)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
yeast, unspecified (UNII: 3NY3SM6B8U)
betula pubescens bark (UNII: 3R504894L9)
cucumber (UNII: YY7C30VXJT)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
apple (UNII: B423VGH5S9)
wheat bran (UNII: 6L966A1IMR)
saccharomyces lysate (UNII: R85W246Z1C)
pomegranate juice (UNII: 99S671U9KB)
black olive (UNII: 2M6QWV94OC)
turmeric (UNII: 856YO1Z64F)
rice bran (UNII: R60QEP13IC)
citrus maxima fruit rind (UNII: 5NX3G75CA6)
polyethylene glycol 300 (UNII: 5655G9Y8AQ)
cholesterol (UNII: 97C5T2UQ7J)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
glycerin (UNII: PDC6A3C0OX)
steareth-21 (UNII: 53J3F32P58)
caffeine (UNII: 3G6A5W338E)
powdered cellulose (UNII: SMD1X3XO9M)
n-acetylglucosamine (UNII: V956696549)
tromethamine (UNII: 023C2WHX2V)
sucrose (UNII: C151H8M554)
salicylic acid (UNII: O414PZ4LPZ)
hyaluronate sodium (UNII: YSE9PPT4TH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
trisiloxane (UNII: 9G1ZW13R0G)
linoleic acid (UNII: 9KJL21T0QJ)
caprylyl glycol (UNII: 00YIU5438U)
sodium sulfite (UNII: VTK01UQK3G)
sodium metabisulfite (UNII: 4VON5FNS3C)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
betaine (UNII: 3SCV180C9W)
trehalose (UNII: B8WCK70T7I)
hexylene glycol (UNII: KEH0A3F75J)
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
polihexanide (UNII: 322U039GMF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-027-01	1 in 1 CARTON	06/01/2012
1		50 mL in 1 JAR; 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	06/01/2012

Labeler - Clinique Laboratories, LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-027) , REPACK(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-027) , REPACK(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-027) , REPACK(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-027)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-027)