Label: DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN- avobenzone and octisalate cream

  • NDC Code(s): 11559-049-01, 11559-049-02, 11559-049-03
  • Packager: ESTEE LAUDER INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.00%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\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 • psidium guajava (guava) fruit extract • gentiana lutea (gentian) root extract • polygonum cuspidatum root extract • stearyl alcohol • hordeum vulgare (barley) extract\extrait d'orge • laminaria ochroleuca extract • rosmarinus officinalis (rosemary) leaf extract • triticum vulgare (wheat) germ extract • artemia extract • caffeine • pentylene glycol • hydrolyzed rice extract • vitis vinifera (grape) seed extract • hydrolyzed rice bran extract • lauryl peg-9 polydimethylsiloxyethyl dimethicone • thermus thermophillus ferment • behenyl alcohol • acrylic acid/vp crosspolymer • triacontanyl pvp • glycerin • c12-15 alkyl benzoate • linoleic acid • cholesterol • squalane • sodium pca • 1,2-hexanediol • urea • caprylic/capric triglyceride • dipropylene glycol dibenzoate • tocopheryl acetate • acrylamide/sodium acryloyldimethyltaurate copolymer • tetrahexyldecyl ascorbate • sodium hyaluronate • ergothioneine • isohexadecane • ppg-15 stearyl ether benzoate • glycyrrhetinic acid • trehalose • polyquaternium-51 • polysorbate 80 • potassium sorbate • lecithin • hydrogenated lecithin • glucose • palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer • caprylyl glycol • cyclodextrin • sodium hydroxide • nordihydroguaiaretic acid • sodium chloride • triacetin • ascorbyl tocopheryl maleate • fragrance (parfum) • citric acid • ethylbisiminomethylguaiacol manganese chloride • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • bht • chlorphenesin • sodium dehydroacetate • phenoxyethanol • blue 1 (ci 42090) • yellow 5 (ci 19140) • chromium hydroxide green (ci 77289) <iln48627>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

    Principal Display PanelESTĒE LAUDER

    DayWear

    Multi-Protection

    Anti-Oxidant

    24H-Moisture Creme

    Broad Spectrum SPF 15

    NORMAL/COMBINATION SKIN

    POIDS NET WT. 1.7 OZ. / 50 ml e

  • INGREDIENTS AND APPEARANCE
    DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN 
    avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  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)  
    CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)  
    GUAVA (UNII: 74O70D6VG0)  
    GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BARLEY (UNII: 5PWM7YLI7R)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    ROSEMARY (UNII: IJ67X351P9)  
    WHEAT GERM (UNII: YR3G369F5A)  
    FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SQUALANE (UNII: GW89575KF9)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    UREA (UNII: 8W8T17847W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    ENOXOLONE (UNII: P540XA09DR)  
    TREHALOSE (UNII: B8WCK70T7I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIACETIN (UNII: XHX3C3X673)  
    NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)  
    .BETA.-CYCLODEXTRIN SULFOBUTYL ETHER (UNII: H1HJ8WR7WG)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    GLUCOSE 1,6-BISPHOSPHATE (UNII: DRX17R6AM2)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    RICE BRAN (UNII: R60QEP13IC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-049-011 in 1 CARTON12/01/2017
    150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:11559-049-021 in 1 CARTON12/01/2022
    215 mL in 1 JAR; Type 0: Not a Combination Product
    3NDC:11559-049-0330 mL in 1 JAR; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/01/2017
    Labeler - ESTEE LAUDER INC (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(11559-049) , label(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture(11559-049) , pack(11559-049) , label(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(11559-049) , pack(11559-049) , label(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(11559-049) , label(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(11559-049) , label(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326label(11559-049) , pack(11559-049) , manufacture(11559-049)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(11559-049) , label(11559-049)
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