DailyMed - REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

Contains inactivated NDC Code(s)
NDC Code(s): 49527-009-01, 49527-009-02
Packager: CLINIQUE LABORATORIES INC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 17, 2011

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ACTIVE INGREDIENT
active ingredients: octinoxate 7.50% [] titanium dioxide 1.40%

active ingredients: octinoxate 7.50% [] titanium dioxide 1.40%
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INACTIVE INGREDIENT
ingredients: water [] cetyl ethylhexanoate [] butylene glycol [] glyceryl stearate [] peg-100 stearate [] octyldodecyl neopentanoate [] hydrogenated lecithin [] pentylene glycol [] coleus barbatus ...

ingredients: water [] cetyl ethylhexanoate [] butylene glycol [] glyceryl stearate [] peg-100 stearate [] octyldodecyl neopentanoate [] hydrogenated lecithin [] pentylene glycol [] coleus barbatus extract [] prunus amygdalus dulcis (sweet almond) seed extract [] olea europaea (olive) fruit extract [] triticum vulgare (wheat bran) extract [] sigesbeckia orientalis extract [] cholesterol/potassium sulfate [] persea gratissima (avocado) oil [] cucumis melo (melon) fruit extract [] betula alba (birch) bark extract [] decarboxy carnosine hcl [] polygonum cuspidatum root extract [] coffea robusta seed extract [] saccharomyces lysate extract [] isomerized linoleic acid [] whey protein [] glycerin [] creatine [] algae extract [] thermus thermophillus ferment [] linoleic acid [] cholesterol [] adenosine phosphate [] sodium dna [] polyethylene [] caffeine [] glycine soja (soybean) sterols [] lecithin [] astrocaryum murumuru seed butter [] trehalose [] acetyl hexapeptide-8 [] sodium rna [] sorbitol [] aminopropyl ascorbyl phosphate [] propylene glycol dicaprylate [] ethylhexyl palmitate [] sodium hyaluronate [] silica [] ethylhexyl stearate [] behenyl alcohol [] caprylyl glycol [] phytosphingosine [] hexylene glycol [] propylene glycol dicaprate [] ethylhexylglycerin [] xanthan gum [] carbomer [] potassium carbomer [] aluminum stearate [] potassium stearate [] disodium edta [] sodium dehydroacetate [] phenoxyethanol
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WARNINGS
warning: keep out of eyes. stop use if irritation occurs

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

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KEEP OUT OF REACH OF CHILDREN
keep out of reach of children

keep out of reach of children

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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - CLINIQUE - REPAIRWEAR LIFT SPF 15 - FIRMING CREAM - OILY/COMB SKIN - NT WT 1.7 OZ./50 ML - clinique laboratories distr. new york, ny 10022

PRINCIPAL DISPLAY PANEL

CLINIQUE

REPAIRWEAR LIFT SPF 15

FIRMING CREAM

OILY/COMB SKIN

NT WT 1.7 OZ./50 ML

clinique laboratories distr.

new york, ny 10022

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INGREDIENTS AND APPEARANCE

Product Information

REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49527-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.4 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL MONOSTEARATE (UNII: F76354LMGR)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
OLIVE OIL (UNII: 6UYK2W1W1E)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
CHOLESTEROL (UNII: 97C5T2UQ7J)
AVOCADO OIL (UNII: 6VNO72PFC1)
CUCUMBER JUICE (UNII: 61845009SP)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
CREATINE (UNII: MU72812GK0)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
CAFFEINE (UNII: 3G6A5W338E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
TREHALOSE (UNII: B8WCK70T7I)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description
Packaging
1	NDC:49527-009-01	1 in 1 CARTON
1	NDC:49527-009-02	50 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2010

Labeler - CLINIQUE LABORATORIES INC (173047747)

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

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

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

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

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

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

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

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

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

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

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

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

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

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Label: REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

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	NDC
1	49527-009-01 (inactivated)
2	49527-009-02

Label: REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

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REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

Number of versions: 1

REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

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REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN- octinoxate, titanium dioxide cream

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.