Label: LOREAL PARIS SKIN PARADISE WATER INFUSED TINTED MOISTURIZER BROAD SPECTRUM SPF 19 SUNSCREEN- ensulizole liquid

  • NDC Code(s): 49967-767-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Ensulizole 3.5%

  • Purpose

    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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    ● shake well before using

    ● apply liberally 15 minutes before sun exposure

    ● reapply at least every 2 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

  • Other information

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

  • Inactive ingredients

    water, glycerin, caprylyl methicone, propanediol, dimethicone, pentylene glycol, dimethicone/PEG-10/15 crosspolymer, sodium hydroxide, sodium chloride, phenoxyethanol, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, isopropyl titanium triisostearate, chlorphenesin, disodium EDTA, aloe barbadensis leaf juice powder, hamamelis virginiana (witch hazel) water, alumina, butylene glycol, fragrance,
    stearic acid, aluminum hydroxide, dipropylene glycol, alcohol, sodium hyaluronate, sodium citrate, limonene, citronellol, tocopherol, zingiber officinale (ginger) root extract
    sanguisorba officinalis root extract, cinnamomum cassia bark extract, citric acid; may contain: titanium dioxide, iron oxides

  • Questions or comments?

    1-800-322-2036

    Monday - Friday

    (10 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a tube

    image of a tube
  • PRINCIPAL DISPLAY PANEL

    image of a tube

    image of a tube
  • INGREDIENTS AND APPEARANCE
    LOREAL PARIS SKIN PARADISE WATER INFUSED TINTED MOISTURIZER BROAD SPECTRUM SPF 19 SUNSCREEN 
    ensulizole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-767
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GINGER (UNII: C5529G5JPQ)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-767-0130 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2020
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-767)