DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN- avobenzone and octisalate cream

DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN by

Drug Labeling and Warnings

DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Octisalate 5.00%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 and evenly 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 dimethicone butyloctyl salicylate butylene glycol polyester-8 cetyl ricinoleate steareth-21 steareth-2 di-c12-15 alkyl fumarate caprylic/capric/myristic/stearic triglyceride polysilicone-11 psidium guajava (guava) fruit extract gentiana lutea (gentian) root extract polygonum cuspidatum root extract stearyl alcohol hordeum vulgare (barley) extract\extrait d'orge laminaria ochroleuca extract rosmarinus officinalis (rosemary) leaf extract triticum vulgare (wheat) germ extract artemia extract fumaria officinalis flower/leaf/stem extract caffeine pentylene glycol citrus medica limonum (lemon) fruit extract hydrolyzed rice extract vitis vinifera (grape) seed extract hydrolyzed rice bran extract lauryl peg-9 polydimethylsiloxyethyl dimethicone thermus thermophillus ferment behenyl alcohol acrylic acid/vp crosspolymer triacontanyl pvp glycerin c12-15 alkyl benzoate linoleic acid cholesterol squalane sodium pca 1,2-hexanediol urea caprylic/capric triglyceride dipropylene glycol dibenzoate tocopheryl acetate acrylamide/sodium acryloyldimethyltaurate copolymer tetrahexyldecyl ascorbate sodium hyaluronate ergothioneine isohexadecane ppg-15 stearyl ether benzoate glycyrrhetinic acid trehalose polyquaternium-51 polysorbate 80 lecithin hydrogenated lecithin fumaric acid palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer caprylyl glycol cyclodextrin sodium hydroxide nordihydroguaiaretic acid sodium chloride ascorbyl tocopheryl maleate fragrance (parfum) citric acid ethylbisiminomethylguaiacol manganese chloride pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate disodium edta bht sodium dehydroacetate phenoxyethanol blue 1 (ci 42090) yellow 5 (ci 19140) chromium hydroxide green (ci 77289) <iln39355>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

DayWear
Multi-Protection Anti-Oxidant
24H-Moisture Creme
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butyloctyl salicylate (UNII: 2EH13UN8D3)
butylene glycol (UNII: 3XUS85K0RA)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
cetyl ricinoleate (UNII: 1P677500YD)
steareth-21 (UNII: 53J3F32P58)
steareth-2 (UNII: V56DFE46J5)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
guava (UNII: 74O70D6VG0)
gentiana lutea root (UNII: S72O3284MS)
reynoutria japonica root (UNII: 7TRV45YZF7)
stearyl alcohol (UNII: 2KR89I4H1Y)
barley (UNII: 5PWM7YLI7R)
laminaria ochroleuca (UNII: 4R2124HE76)
rosemary (UNII: IJ67X351P9)
wheat germ (UNII: YR3G369F5A)
fumaria officinalis flowering top (UNII: VH659J61ZL)
caffeine (UNII: 3G6A5W338E)
pentylene glycol (UNII: 50C1307PZG)
lemon (UNII: 24RS0A988O)
vitis vinifera seed (UNII: C34U15ICXA)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
DOCOSANOL (UNII: 9G1OE216XY)
tricontanyl povidone (UNII: N0SS3Q238D)
glycerin (UNII: PDC6A3C0OX)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
squalane (UNII: GW89575KF9)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
1,2-hexanediol (UNII: TR046Y3K1G)
urea (UNII: 8W8T17847W)
medium-chain triglycerides (UNII: C9H2L21V7U)
dipropylene glycol dibenzoate (UNII: 6OA5ZDY41O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ergothioneine (UNII: BDZ3DQM98W)
isohexadecane (UNII: 918X1OUF1E)
ppg-15 stearyl ether benzoate (UNII: 80D2J6361M)
enoxolone (UNII: P540XA09DR)
trehalose (UNII: B8WCK70T7I)
polysorbate 80 (UNII: 6OZP39ZG8H)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
fumaric acid (UNII: 88XHZ13131)
caprylyl glycol (UNII: 00YIU5438U)
sodium hydroxide (UNII: 55X04QC32I)
sodium chloride (UNII: 451W47IQ8X)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
citric acid monohydrate (UNII: 2968PHW8QP)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C yellow no. 5 (UNII: I753WB2F1M)
chromium hydroxide green (UNII: RV8FT8XF5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-049-01	1 in 1 CARTON	12/01/2017
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 not final	part352	12/01/2017

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-049) , REPACK(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-049) , REPACK(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-049) , REPACK(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-049)