DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN- octisalate, avobenzone, homosalate cream

DAYWEAR by

Drug Labeling and Warnings

DAYWEAR by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER 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% [] AVOBENZONE 3.00% [] HOMOSALATE 2.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] BUTYLOCTYL SALICYLATE [] POLYESTER-8 [] PETROLATUM [] BUTYLENE GLYCOL [] CETYL RICINOLEATE [] OCTYLDODECYL MYRISTATE [] STEARETH-21 [] STEARETH-2 [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] DI-C12-15 ALKYL FUMARATE [] DIMETHICONE [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] LAMINARIA OCHROLEUCA EXTRACT [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] HYDROLYZED RICE EXTRACT [] ARTEMIA EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] STEARYL ALCOHOL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] THERMUS THERMOPHILLUS FERMENT [] SORBITAN OLIVATE [] CAFFEINE [] PENTYLENE GLYCOL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] PANTETHINE [] TRIACONTANYL PVP [] ACRYLIC ACID/VP CROSSPOLYMER [] ETHYLHEXYLGLYCERIN [] GLYCERIN [] LINOLEIC ACID [] POLYQUATERNIUM-51 [] CHOLESTEROL [] CETEARYL OLIVATE [] SQUALANE [] SODIUM PCA [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] CITRIC ACID [] SODIUM HYALURONATE [] ERGOTHIONEINE [] GLYCYRRHETINIC ACID [] TREHALOSE [] LECITHIN [] HYDROGENATED LECITHIN [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] SODIUM HYDROXIDE [] FRAGRANCE (PARFUM) [] FUMARIC ACID [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] BHT [] PHENOXYETHANOL [] BENZYL SALICYLATE [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BUTYLPHENYL METHYLPROPIONAL [] LINALOOL [] MICA [] YELLOW 5 (CI 19140) [] BLUE 1 (CI 42090) [] CHROMIUM HYDROXIDE GREEN (CI 77289)

WARNINGS

WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ESTEE LAUDER

DAYWEAR

ADVANCED MULTI-PROTECTION ANTI-OXIDANT CREME

SPF 15

FOR DRY SKIN

1.7 FL OZ/50 ML

ESTEE LAUDER DISTR

NY NY 10022

INGREDIENTS AND APPEARANCE

DAYWEAR  ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN
octisalate, avobenzone, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SQUALANE (UNII: GW89575KF9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-007-01	1 in 1 CARTON
1	NDC: 11559-007-02	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	09/01/2010

Labeler - ESTEE LAUDER INC (005914387)

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