EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15- avobenzone, homosalate, and octisalate cream

EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM by

Drug Labeling and Warnings

EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 3.0%
Octisalate 5.0%

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:

• 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 tricaprylyl citrate butylene glycol butyrospermum parkii (shea butter) yeast extract\faex\extrait de levure cetearyl alcohol polymethyl methacrylate glycerin sucrose polyester-8 saccharomyces cerevisiae extract peg-100 stearate dimethicone glyceryl stearate hordeum vulgare (barley) extract\extrait d'orge cucumis sativus (cucumber) fruit extract saccharomyces lysate extract scutellaria baicalensis root extract morus bombycis (mulberry) root extract betula alba (birch) bark extract oryza sativa (rice) bran extract chamomilla recutita (matricaria) extract helianthus annuus (sunflower) seedcake caffeine polyglutamic acid salicylic acid propylene glycol dicaprate sodium rna dipotassium glycyrrhizate acetyl glucosamine phospholipids arginine sodium hyaluronate squalane cetearyl glucoside ethylhexylglycerin isohexadecane tocopheryl acetate polysorbate 80 caprylyl glycol magnesium ascorbyl phosphate acrylamide/sodium acryloyldimethyltaurate copolymer xanthan gum disodium edta phenoxyethanol [iln38633]

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

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

CLINIQUE

even better

dark spot correcting
hand cream
broad spectrum
SPF 15

ALL SKIN TYPES

2.5 FL.OZ.LIQ./75 ml e

INGREDIENTS AND APPEARANCE

EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM   SPF 15
avobenzone, homosalate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.03 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
tricaprylyl citrate (UNII: BXW1GAI4TA)
butylene glycol (UNII: 3XUS85K0RA)
shea butter (UNII: K49155WL9Y)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
cetostearyl alcohol (UNII: 2DMT128M1S)
glycerin (UNII: PDC6A3C0OX)
sucrose (UNII: C151H8M554)
saccharomyces cerevisiae (UNII: 978D8U419H)
peg-100 stearate (UNII: YD01N1999R)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
barley (UNII: 5PWM7YLI7R)
cucumber (UNII: YY7C30VXJT)
saccharomyces lysate (UNII: R85W246Z1C)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
morus australis root (UNII: 1VL55O45RF)
betula pubescens bark (UNII: 3R504894L9)
rice bran (UNII: R60QEP13IC)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
helianthus annuus seedcake (UNII: 482WYF7XLC)
caffeine (UNII: 3G6A5W338E)
salicylic acid (UNII: O414PZ4LPZ)
propylene glycol dicaprate (UNII: U783H9JHWY)
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)
n-acetylglucosamine (UNII: V956696549)
arginine (UNII: 94ZLA3W45F)
hyaluronate sodium (UNII: YSE9PPT4TH)
squalane (UNII: GW89575KF9)
cetearyl glucoside (UNII: 09FUA47KNA)
ethylhexylglycerin (UNII: 147D247K3P)
isohexadecane (UNII: 918X1OUF1E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
polysorbate 80 (UNII: 6OZP39ZG8H)
caprylyl glycol (UNII: 00YIU5438U)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-013-01	1 in 1 CARTON	09/01/2011
1		75 mL in 1 BOTTLE; 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	09/01/2011

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-013) , REPACK(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-013) , REPACK(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-013) , REPACK(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-013)