DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15- avobenzone, homosalate, octisalate cream

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15 by

Drug Labeling and Warnings

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

AVOBENZONE 3.0%
HOMOSALATE 2.0%
OCTISALATE 5.0%

Purpose

Sunscreen

Uses

-helps precent sunburn

-if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging cause by the seun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eye. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m.–2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses
children under 6 months of age: ask a doctor

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,TETRAHEXYLDECYL ASCORBATE,TOCOPHERYL ACETATE,THERMUS THERMOPHILLUS FERMENT,ERGOTHIONEINE,ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE,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,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,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,CITRIC ACID,SODIUM HYALURONATE,GLYCYRRHETINIC ACID,TREHALOSE,TRIACETIN,LECITHIN,HYDROGENATED LECITHIN,GLUCOSE,TOCOPHEROL,PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER,CYCLODEXTRIN,NORDIHYDROGUAIARETIC ACID,ASCORBYL TOCOPHERYL MALEATE,SODIUM HYDROXIDE,FRAGRANCE (PARFUM),PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,SODIUM CHLORIDE,DISODIUM EDTA,BHT,POTASSIUM SORBATE,CHLORPHENESIN,PHENOXYETHANOL,BENZYL SALICYLATE,LINALOOL,MICA,YELLOW 5 (CI 19140),BLUE 1 (CI 42090),CHROMIUM HYDROXIDE GREEN (CI 77289) <ILN48744>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

Estee Lauder

DayWear

Multi-Protection Anti-Oxidant
24H-Moisture Creme

Broad Spectrum SPF15

Dry Skin

POIDS NET WT. 1.7OZ/5.ml e

INGREDIENTS AND APPEARANCE

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE (UNII: WHF5JJR62Y)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ENOXOLONE (UNII: P540XA09DR)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MICA (UNII: V8A1AW0880)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
WHEAT GERM (UNII: YR3G369F5A)
STEARETH-2 (UNII: V56DFE46J5)
DOCOSANOL (UNII: 9G1OE216XY)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
ROSEMARY (UNII: IJ67X351P9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TREHALOSE (UNII: B8WCK70T7I)
MASOPROCOL (UNII: 7BO8G1BYQU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
CETYL RICINOLEATE (UNII: 1P677500YD)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GUAVA (UNII: 74O70D6VG0)
CAFFEINE (UNII: 3G6A5W338E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PANTETHINE (UNII: 7K81IL792L)
SQUALANE (UNII: GW89575KF9)
TRIACETIN (UNII: XHX3C3X673)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER (UNII: 7F9WLW26M2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PETROLATUM (UNII: 4T6H12BN9U)
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)
SHEA BUTTER (UNII: K49155WL9Y)
CHOLESTEROL (UNII: 97C5T2UQ7J)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
UREA (UNII: 8W8T17847W)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-064-01	1 in 1 CARTON	11/13/2023
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/13/2023

Labeler - ESTEE LAUDER INC (005914387)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(11559-064) , label(11559-064) , pack(11559-064)