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

REPAIRWEAR by

Drug Labeling and Warnings

REPAIRWEAR 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: octinoxate 7.50% [] titanium dioxide 1.40%

INACTIVE INGREDIENT

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-009-01	1 in 1 CARTON
1	NDC: 49527-009-02	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	12/01/2010

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