DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE by

Drug Labeling and Warnings

DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Homosalate 5.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	Sunscreen
Oxybenzone 3.00%	Sunscreen

Use

helps prevent sunburn

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 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 methyl trimethicone neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol glyceryl stearate dipentaerythrityl tri-polyhydroxystearate potassium cetyl phosphate gentiana lutea (gentian) root extract polygonum cuspidatum root extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract fumaria officinalis flower/leaf/stem extract citrus medica limonum (lemon) fruit extract hydrolyzed rice bran extract hydrolyzed rice extract rosmarinus officinalis (rosemary) leaf extract vitis vinifera (grape) seed extract artemia extract laminaria ochroleuca extract algae extract hydrogenated lecithin thermus thermophillus ferment squalane glycerin sorbitol linoleic acid caffeine cholesterol ethylhexylglycerin lecithin ergothioneine sodium hyaluronate polyquaternium-51 cetyl alcohol trehalose palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer ammonium acryloyldimethyltaurate/vp copolymer vp/eicosene copolymer tetrahexyldecyl ascorbate saccharide isomerate caprylyl glycol caprylic/capric triglyceride sodium pca cyclodextrin urea dehydroxanthan gum tocopheryl acetate glycyrrhetinic acid nordihydroguaiaretic acid ascorbyl tocopheryl maleate citric acid stearic acid sodium dehydroacetate fumaric acid ethylbisiminomethylguaiacol manganese chloride silica phenoxyethanol disodium edta bht fragrance (parfum) mica titanium dioxide (ci 77891) blue 1 (ci 42090) yellow 5 (ci 19140) <iln39694>

Other information

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

SPL UNCLASSIFIED SECTION

DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

EL

ESTĒE LAUDER

DayWear

Advanced Multi-Protection
Anti-Oxidant & UV Defense

Broad Spectrum
SPF 50

All Skintypes

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE   BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0312 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.052 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.052 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02808 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0312 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
methyl trimethicone (UNII: S73ZQI0GXM)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
kukui nut oil (UNII: TP11QR7B8R)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
gentiana lutea root (UNII: S72O3284MS)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
wheat germ (UNII: YR3G369F5A)
fumaria officinalis flowering top (UNII: VH659J61ZL)
lemon (UNII: 24RS0A988O)
rosemary (UNII: IJ67X351P9)
vitis vinifera seed (UNII: C34U15ICXA)
laminaria ochroleuca (UNII: 4R2124HE76)
squalene (UNII: 7QWM220FJH)
glycerin (UNII: PDC6A3C0OX)
sorbitol (UNII: 506T60A25R)
linoleic acid (UNII: 9KJL21T0QJ)
caffeine (UNII: 3G6A5W338E)
cholesterol (UNII: 97C5T2UQ7J)
ethylhexylglycerin (UNII: 147D247K3P)
ergothioneine (UNII: BDZ3DQM98W)
hyaluronate sodium (UNII: YSE9PPT4TH)
cetyl alcohol (UNII: 936JST6JCN)
trehalose (UNII: B8WCK70T7I)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
saccharide isomerate (UNII: W8K377W98I)
caprylyl glycol (UNII: 00YIU5438U)
medium-chain triglycerides (UNII: C9H2L21V7U)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
enoxolone (UNII: P540XA09DR)
masoprocol (UNII: 7BO8G1BYQU)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
citric acid monohydrate (UNII: 2968PHW8QP)
stearic acid (UNII: 4ELV7Z65AP)
sodium dehydroacetate (UNII: 8W46YN971G)
fumaric acid (UNII: 88XHZ13131)
silicon dioxide (UNII: ETJ7Z6XBU4)
phenoxyethanol (UNII: HIE492ZZ3T)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C yellow no. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-026-01	1 in 1 CARTON	11/07/2012
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 NOT FINAL	part352	11/07/2012

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-026) , REPACK(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-026) , REPACK(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-026) , REPACK(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-026)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-026)