REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN- octinoxate, octisalate, titanium dioxide cream

REPAIRWEAR LIFT by

Drug Labeling and Warnings

REPAIRWEAR LIFT 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% [] octisalate 3.50% [] titanium dioxide 1.00%

INACTIVE INGREDIENT

inactive ingredients: water [] neopentyl glycol diheptanoate [] cetyl alcohol [] glycerin [] polyethylene [] di-c12-15 alkyl fumarate [] petrolatum [] hydrogenated lecithin [] butylene glycol [] pentylene glycol [] isocetyl alcohol [] hydrogenated polyisobutene [] octyldodecyl myristate [] pentaerythrityl tetraethylhexanoate [] hexyldecyl stearate [] behenyl alcohol [] potato starch modified [] prunus amygdalus dulcis (sweet almond) seed extract [] olea europaea (olive) fruit extract [] coleus barbatus extract [] cucumis melo (melon) fruit extract [] saccharomyces lysate extract [] triticum vulgare (wheat bran) extract [] coffea robusta seed extract [] whey protein\lactis protein\protéine du petit-lait [] betula alba (birch) bark extract [] algae extract [] octyldodecyl neopentanoate [] persea gratissima (avocado) oil [] sigesbeckia orientalis (st. paul's wort) extract [] polygonum cuspidatum root extract [] thermus thermophillus ferment [] isomerized linoleic acid [] dimethicone [] c12-16 alcohols [] linoleic acid [] peg-100 stearate [] caprylyl glycol [] caffeine [] palmitic acid [] glycine soja (soybean) sterols [] aluminum stearate [] glyceryl stearate [] trehalose [] sodium rna [] creatine [] hexylene glycol [] sorbitol [] polysilicone-11 [] adenosine phosphate [] aminopropyl ascorbyl phosphate [] propylene glycol dicaprylate [] cholesterol/potassium sulfate [] ethylhexyl palmitate [] sodium hyaluronate [] decarboxy carnosine hcl [] cholesterol [] sodium dna [] astrocaryum murumuru seed butter [] ethylhexyl stearate [] phytosphingosine [] propylene glycol dicaprate [] acetyl hexapeptide-8 [] xanthan gum [] sodium stearate [] sodium carbomer [] sodium citrate [] disodium edta [] potassium sorbate [] 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

REPAIRWEAR LIFT SPF 15

FIRMING DAY CREAM

DRY COMBINATION SKIN

1.7  OZ/ 50 ML

CLINIQUE LABORATORIES DISTR.

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

REPAIRWEAR LIFT  SPF 15 FIRMING DAY DRY COMBO SKIN
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-719
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOCETYL ALCOHOL (UNII: 1800H64066)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
DOCOSANOL (UNII: 9G1OE216XY)
STARCH, POTATO (UNII: 8I089SAH3T)
ALMOND (UNII: 3Z252A2K9G)
OLIVE OIL (UNII: 6UYK2W1W1E)
PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)
CUCUMBER (UNII: YY7C30VXJT)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
WHEAT GERM (UNII: YR3G369F5A)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
WHEY (UNII: 8617Z5FMF6)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
SEAWEED (UNII: 477TV3P5UX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAFFEINE (UNII: 3G6A5W338E)
PALMITIC ACID (UNII: 2V16EO95H1)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TREHALOSE (UNII: B8WCK70T7I)
CREATINE (UNII: MU72812GK0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SORBITOL (UNII: 506T60A25R)
ADENOSINE PHOSPHATE (UNII: 415SHH325A)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-719-01	1 in 1 CARTON
1	NDC: 49527-719-02	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	04/01/2007

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