VITAMIN E MOISTURIZING DAY SPF 15- avobenzone and octisalate cream 
JO MALONE LTD

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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VITAMIN E MOISTURIZING DAY CREAM SPF 15

Drug Facts

Active IngredientsPurpose
Avobenzone 3.00%Sunscreen
Octisalate 5.00%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., 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, gentiana lutea (gentian) root extract, polygonum cuspidatum root extract, hordeum vulgare (barley) extract\extrait d'orge , triticum vulgare (wheat) germ extract, laminaria ochroleuca extract, hydrolyzed rice extract, fumaria officinalis flower/leaf/stem extract, citrus medica limonum (lemon) fruit extract, hydrolyzed rice bran extract, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grape) seed extract, artemia extract, thermus thermophillus ferment, stearyl alcohol, pentylene glycol, polyquaternium-51, lauryl peg-9 polydimethylsiloxyethyl dimethicone, behenyl alcohol, triacontanyl pvp, glycerin, lecithin, c12-15 alkyl benzoate, linoleic acid, caffeine, cholesterol, squalane, sodium pca, acrylic acid/vp crosspolymer, urea, 1 ,2-hexanediol, caprylic/capric triglyceride, dipropylene glycol dibenzoate, tocopheryl acetate, tetrahexyldecyl ascorbate, sodium hyaluronate, ppg-15 stearyl ether benzoate, glycyrrhetinic acid, trehalose, hydrogenated lecithin, fumaric acid, palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer, cyclodextrin, nordihydroguaiaretic acid, ascorbyl tocopheryl maleate, caprylyl glycol, ergothioneine, sodium chloride, fragrance (parfum), sodium hydroxide, citric acid, ethylbisiminomethylguaiacol manganese chloride, disodium edta, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium dehydroacetate, phenoxyethanol <iln37878>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

Jo MALONE

LONDON

VITAMIN E MOISTURISING DAY CRÈME SPF 15

PRINCIPAL DISPLAY PANEL - 50 ML Jar Label
VITAMIN E MOISTURIZING DAY SPF 15 
avobenzone and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62874-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
BARLEY (UNII: 5PWM7YLI7R)  
WHEAT (UNII: 4J2I0SN84Y)  
LEMON (UNII: 24RS0A988O)  
ROSEMARY (UNII: IJ67X351P9)  
GRAPE (UNII: 6X543N684K)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DOCOSANOL (UNII: 9G1OE216XY)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CAFFEINE (UNII: 3G6A5W338E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SQUALANE (UNII: GW89575KF9)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
UREA (UNII: 8W8T17847W)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
ENOXOLONE (UNII: P540XA09DR)  
TREHALOSE (UNII: B8WCK70T7I)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
FUMARIC ACID (UNII: 88XHZ13131)  
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62874-006-0150 mL in 1 JAR; Type 0: Not a Combination Product09/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201111/16/2020
Labeler - JO MALONE LTD (347366049)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(62874-006) , REPACK(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(62874-006) , REPACK(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(62874-006) , REPACK(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(62874-006)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(62874-006)

Revised: 11/2020
 
JO MALONE LTD