SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION- oxybenzone, octisalate, avobenzone cream

SUPER DEFENSE by

Drug Labeling and Warnings

SUPER DEFENSE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: octisalate 5.00% [] oxybenzone 5.00% [] avobenzone 3.00%

INACTIVE INGREDIENT

inactive ingredients: water\aqua\eau [] dimethicone [] butyloctyl salicylate [] polyester-8 [] butylene glycol [] cetearyl alcohol [] silica [] glyceryl stearate [] peg-100 stearate [] glycerin [] hydrogenated lecithin [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] padina pavonica (thallus) extract [] petrolatum [] isopropyl ppg-2-isodeceth-7 carboxylate [] sea whip extract [] jojoba esters [] adenosine phosphate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] lauroyl lysine [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] sucrose [] micrococcus lysate [] astrocaryum murumuru seed butter [] cetearyl glucoside [] laurdimonium hydroxypropyl hydrolyzed soy protein [] dimethiconol [] lecithin [] algae extract [] hexylene glycol [] ethylhexyl stearate [] ethylhexyl palmitate [] propylene glycol dicaprate [] chamomilla recutita (matricaria) [] caprylyl glycol [] isohexadecane [] polyethylene [] ethylhexylglycerin [] zeolite [] behenyl alcohol [] polysorbate 80 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] acrylates/c10-30 alkyl acrylate crosspolymer [] tromethamine [] arginine ferulate [] decarboxy carnosine hcl [] xanthan gum [] sodium chloride [] potassium sulfate [] disodium edta [] phenoxyethanol

WARNINGS

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

CLINIQUE

SUPERDEFENSE SPF

AGE DEFENSE MOISTURIZER

SPF 25

DRY COMBINATION SKIN

NT WT. 1.7 OZ./50 ML

CLINIQUE LABORATORIES INC, DISTR

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

SUPER DEFENSE  SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION
oxybenzone, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-707
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ECHINACEA PALLIDA (UNII: 904CK3270L)
ROSEMARY (UNII: IJ67X351P9)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
TREHALOSE (UNII: B8WCK70T7I)
CREATINE (UNII: MU72812GK0)
CAFFEINE (UNII: 3G6A5W338E)
MASOPROCOL (UNII: 7BO8G1BYQU)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADENOSINE PHOSPHATE DISODIUM (UNII: T1WZ11DSRN)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOHEXADECANE (UNII: 918X1OUF1E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARETH-21 (UNII: 53J3F32P58)
SUCROSE (UNII: C151H8M554)
TROMETHAMINE (UNII: 023C2WHX2V)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
LAUROYL LYSINE (UNII: 113171Q70B)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-707-01	1 in 1 CARTON
1	NDC: 49527-707-02	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2008

Labeler - CLINIQUE LABORATORIES INC (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture