EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45- ensulizole, octinoxate, octisalate, and zinc oxide liquid

EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45 by

Drug Labeling and Warnings

EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder N.V., OLEN COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

ENSULIZOLE 2.7%
OCTINOXATE 6.7%
OCTISALATE 4.5%
ZINC OXIDE 7.7%

Purpose

Sunscreen

Use

helps prevent sunburn

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. 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,methyl trimethicone,dimethicone,niacinamide,neopentyl glycol diheptanoate,phenyl trimethicone,glycerin,tromethamine,lauryl peg-9 polydimethylsiloxyethyl dimethicone,hdi/ppg/polycaprolactone crosspolymer,trimethylsiloxysilicate,polysilicone-11,hexyl laurate,cetyl peg/ppg-10/1 dimethicone,butylene glycol,ascorbyl glucoside,sodium hyaluronate,caffeine,hydrolyzed wheat protein/pvp crosspolymer,polyglyceryl-4 isostearate,trehalose,acetyl glucosamine,triethyl citrate,hydrogenated coco-glycerides,aminopropyl ascorbyl phosphate,dimethicone/divinyldimethicone/silsesquioxane crosspolymer,polyethylene,silica,polymethylsilsesquioxane,disteardimonium hectorite,polyhydroxystearic acid,glyceryl stearate,cetearyl alcohol,ammonium polyacryloyldimethyl taurate,polysorbate 80,stearic acid,polysorbate 20,lecithin,hydrogenated lecithin,palmitic acid,laureth-7,sodium phosphate,disodium phosphate,potassium hydroxide,stearyl alcohol,behenyl alcohol,triethoxycaprylylsilane,ascorbyl palmitate,tocopheryl acetate,magnesium ascorbyl phosphate,tetrahexyldecyl ascorbate,bht,disodium edta,phenoxyethanol,potassium sorbate,sodium dehydroacetate, [+/- mica,titanium dioxide (ci 77891),iron oxides (ci 77491),iron oxides (ci 77492),iron oxides (ci 77499)] <iln53082>

Other information

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

PRINCIPAL DISPLAY PANEL

CLINIQUE

even better clinical

vitamon makeup

broad spectrum SPF 45

1 FL.OZ.LIQ/30 ml

INGREDIENTS AND APPEARANCE

EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45 
ensulizole, octinoxate, octisalate, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	77 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	27 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURETH-7 (UNII: Z95S6G8201)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TREHALOSE (UNII: B8WCK70T7I)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAFFEINE (UNII: 3G6A5W338E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SOYBEAN (UNII: L7HT8F1ZOD)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
TROMETHAMINE (UNII: 023C2WHX2V)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
NIACINAMIDE (UNII: 25X51I8RD4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-220-01	1 in 1 CARTON	10/04/2024
1		30 mL in 1 BOTTLE; 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	10/04/2024

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture(49527-220)

Establishment
Name	Address	ID/FEI	Business Operations
OLEN COSMETICS		295870216	pack(49527-220) , label(49527-220)