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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DAYWEAR
ADVANCED MULTI-PROTECTION ANTI -OXIDANT CREAM OIL- FREE BROAD SPECTRUM SPF 25

Drug Facts

Active ingredientsPurpose
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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
DAYWEAR   ADVANCED MULTI-PROTECTION ANTI-OXIDANT OIL-FREE BROAD SPECTRUM SPF 25
avobenzone, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.0303 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.02727 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-023-011 in 1 CARTON01/01/2012
150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/201211/19/2020
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(11559-023) , REPACK(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(11559-023) , REPACK(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(11559-023) , REPACK(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-023)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(11559-023)

Revised: 12/2018
 
ESTEE LAUDER INC