DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT BROAD SPECTRUM CREME SPF 15 FOR DRY SKIN- octinoxate, avobenzone, and homosalate cream

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT BROAD SPECTRUM CREME SPF 15 FOR DRY SKIN by

Drug Labeling and Warnings

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT BROAD SPECTRUM CREME SPF 15 FOR DRY SKIN by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, 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
Homosalate 2.00%	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\eaubutyloctyl salicylatepolyester-8petrolatumbutylene glycolcetyl ricinoleateoctyldodecyl myristatesteareth-21steareth-2caprylic/capric/myristic/stearic triglyceridedi-c12-15 alkyl fumaratedimethiconepsidium guajava (guava) fruit extractgentiana lutea (gentian) root extractpolygonum cuspidatum root extracthordeum vulgare (barley) extract\extrait d'orgelaminaria ochroleuca extracttriticum vulgare (wheat) germ extractfumaria officinalis flower/leaf/stem extractcitrus medica limonum (lemon) fruit extracthydrolyzed rice bran extracthydrolyzed rice extractartemia extractrosmarinus officinalis (rosemary) leaf extractvitis vinifera (grape) seed extractstearyl alcoholbutyrospermum parkii (shea butter)thermus thermophillus fermentsorbitan olivatecaffeinepentylene glycollauryl peg-9 polydimethylsiloxyethyl dimethiconebehenyl alcoholpantethinetriacontanyl pvpacrylic acid/vp crosspolymerethylhexylglyceringlycerinlinoleic acidpolyquaternium-51cholesterolcetearyl olivatesqualanesodium pcaureacaprylic/capric triglyceridetocopheryl acetatetetrahexyldecyl ascorbatecitric acidsodium hyaluronateergothioneineglycyrrhetinic acidtrehaloselecithinhydrogenated lecithinpalmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymercyclodextrinnordihydroguaiaretic acidascorbyl tocopheryl maleatesodium hydroxidefragrance (parfum)fumaric acidpentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamateethylbisiminomethylguaiacol manganese chloridedisodium edtabhtphenoxyethanolbenzyl salicylatehydroxyisohexyl 3-cyclohexene carboxaldehydebutylphenyl methylpropionallinaloolmicayellow 5 (ci 19140)blue 1 (ci 42090)chromium hydroxide green (ci 77289) <iln37542>

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

Dry Skin
NET WT. 1.7 OZ./50ml e

INGREDIENTS AND APPEARANCE

DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT BROAD SPECTRUM CREME SPF 15 FOR DRY SKIN 
octinoxate, avobenzone, and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0495 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0297 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.098 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
polyester-8 (1400 MW, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
petrolatum (UNII: 4T6H12BN9U)
butylene glycol (UNII: 3XUS85K0RA)
cetyl ricinoleate (UNII: 1P677500YD)
octyldodecyl myristate (UNII: S013N99GR8)
steareth-21 (UNII: 53J3F32P58)
steareth-2 (UNII: V56DFE46J5)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
dimethicone (UNII: 92RU3N3Y1O)
guava (UNII: 74O70D6VG0)
gentiana lutea root (UNII: S72O3284MS)
barley (UNII: 5PWM7YLI7R)
wheat (UNII: 4J2I0SN84Y)
lemon (UNII: 24RS0A988O)
rosemary (UNII: IJ67X351P9)
grape (UNII: 6X543N684K)
stearyl alcohol (UNII: 2KR89I4H1Y)
shea butter (UNII: K49155WL9Y)
thermus thermophilus lysate (UNII: 775R692494)
sorbitan olivate (UNII: MDL271E3GR)
caffeine (UNII: 3G6A5W338E)
pentylene glycol (UNII: 50C1307PZG)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
docosanol (UNII: 9G1OE216XY)
pantethine (UNII: 7K81IL792L)
tricontanyl povidone (UNII: N0SS3Q238D)
ethylhexylglycerin (UNII: 147D247K3P)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
cetearyl olivate (UNII: 58B69Q84JO)
squalane (UNII: GW89575KF9)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
medium-chain triglycerides (UNII: C9H2L21V7U)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
citric acid monohydrate (UNII: 2968PHW8QP)
hyaluronate sodium (UNII: YSE9PPT4TH)
ergothioneine (UNII: BDZ3DQM98W)
enoxolone (UNII: P540XA09DR)
trehalose (UNII: B8WCK70T7I)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
sodium hydroxide (UNII: 55X04QC32I)
fumaric acid (UNII: 88XHZ13131)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
benzyl salicylate (UNII: WAO5MNK9TU)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
butylphenyl methylpropional (UNII: T7540GJV69)
linalool, (+/-)- (UNII: D81QY6I88E)
mica (UNII: V8A1AW0880)
FD&C yellow no. 5 (UNII: I753WB2F1M)
FD&C blue no. 1 (UNII: H3R47K3TBD)
chromium hydroxide green (UNII: RV8FT8XF5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-054-01	1 in 1 CARTON	09/01/2010
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	09/01/2010

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-054) , REPACK(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-054) , REPACK(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-054) , REPACK(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-054)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-054)