DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT OIL-FREE BROAD SPECTRUM SPF 25- avobenzone, octisalate, and octocrylene cream

DAYWEAR by

Drug Labeling and Warnings

DAYWEAR 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
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	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 ethyl macadamiate methyl trimethicone jojoba esters butylene glycol peg-100 stearate neopentyl glycol diheptanoate dimethicone glyceryl stearate cetyl alcohol silica 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 laminaria saccharina extract rosmarinus officinalis (rosemary) leaf extract vitis vinifera (grape) seed extract artemia extract hydrogenated lecithin thermus thermophillus ferment squalane glycerin linoleic acid caffeine ethylhexylglycerin cholesterol lecithin dipotassium glycyrrhizate ergothioneine sodium hyaluronate polyquaternium-51 lauryl peg-9 polydimethylsiloxyethyl dimethicone trehalose palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer ammonium acryloyldimethyltaurate/vp copolymer tetrahexyldecyl ascorbate caprylyl glycol sodium pca cyclodextrin urea dehydroxanthan gum stearic acid tocopheryl acetate nordihydroguaiaretic acid ascorbyl tocopheryl maleate citric acid sodium dehydroacetate fumaric acid ethylbisiminomethylguaiacol manganese chloride pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate phenoxyethanol disodium edta bht fragrance (parfum) butylphenyl methylpropional benzyl salicylate linalool hydroxyisohexyl 3-cyclohexene carboxaldehyde mica blue 1 (ci 42090) chromium hydroxide green (ci 77289) yellow 5 (ci 19140) [iln38199]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

DayWear
Advanced Multi-Protection Anti-Oxidant Creme
Oil-Free Broad Spectrum SPF 25

All Skintypes

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

DAYWEAR   ADVANCED MULTI-PROTECTION ANTI-OXIDANT OIL-FREE BROAD SPECTRUM SPF 25
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0303 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02727 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
ethyl macadamiate (UNII: ANA2NCS6V1)
methyl trimethicone (UNII: S73ZQI0GXM)
butylene glycol (UNII: 3XUS85K0RA)
peg-100 stearate (UNII: YD01N1999R)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
cetyl alcohol (UNII: 936JST6JCN)
silicon dioxide (UNII: ETJ7Z6XBU4)
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)
saccharina latissima (UNII: 68CMP2MB55)
rosemary (UNII: IJ67X351P9)
vitis vinifera seed (UNII: C34U15ICXA)
squalane (UNII: GW89575KF9)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
caffeine (UNII: 3G6A5W338E)
ethylhexylglycerin (UNII: 147D247K3P)
cholesterol (UNII: 97C5T2UQ7J)
glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)
ergothioneine (UNII: BDZ3DQM98W)
hyaluronate sodium (UNII: YSE9PPT4TH)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
trehalose (UNII: B8WCK70T7I)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
caprylyl glycol (UNII: 00YIU5438U)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
stearic acid (UNII: 4ELV7Z65AP)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
masoprocol (UNII: 7BO8G1BYQU)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium dehydroacetate (UNII: 8W46YN971G)
fumaric acid (UNII: 88XHZ13131)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
phenoxyethanol (UNII: HIE492ZZ3T)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
butylphenyl methylpropional (UNII: T7540GJV69)
benzyl salicylate (UNII: WAO5MNK9TU)
linalool, (+/-)- (UNII: D81QY6I88E)
hydroxyisohexyl 3-cyclohexene carboxaldehyde (UNII: QUE43B9Z2Q)
mica (UNII: V8A1AW0880)
FD&C blue no. 1 (UNII: H3R47K3TBD)
chromium hydroxide green (UNII: RV8FT8XF5R)
FD&C yellow no. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-023-01	1 in 1 CARTON	01/01/2012
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	01/01/2012

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-023) , REPACK(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-023) , REPACK(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-023) , REPACK(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-023)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-023)