Label: EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, octinoxate and octocrylene cream

  • Category: HUMAN OTC DRUG LABEL

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 16, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active Ingredients              Purpose

    Homosalate 10%                   Sunscreen

    Octisalate 5%                        Sunscreen

    Oxybenzone 5%                    Sunscreen

    Avobenzone 3%                    Sunscreen

    Octinoxate 3%                      Sunscreen

    Octocrylene 2.7%                  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

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • 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 iof 15 or higher and other sun protection measures including:

        - limit time in the sun, especially from 10 a.m. - 2 p.m.

        - wear long-sleeve shirts, pants, hats, and sunglasses

  • Inactive ingredients

    water, niacinamide, phenyl trimethicone, cetearyl alcohol, caprylic/capric triglyceride, behentrimonium methosulfate, divinyldimethicone/dimethicone copolymer, polysilicone-15, phenoxyethanol, cetearyl olivate, sorbitan olivate, polyquaternium-37, propylene glycol dicaprylate/dicaprate, spilanthes acmella flower extract, tocopheryl acetate, ascorbyl tetraisopalmitate, ethylhexylglycerin, lactic acid, PPG-1 trideceth-6, C12-13 pareth-3, C12-13 pareth-23, sodium citrate, citric acid, BHT.

  • Other information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY/OUTSIDE PANEL - 5 mL Wallet Sachet

    EVE LOM

    DAILY PROTECTION

    BROAD SPECTRUM SPF 50 SUNSCREEN

    5ml 0.169 FL.OZ. eWallet Sachet Outside

  • INSIDE PANEL - 5 mL Sachet

    Wallet Sachet Inside

  • INGREDIENTS AND APPEARANCE
    EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 
    homosalate, octisalate, oxybenzone, avobenzone, octinoxate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1217
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.5 g  in 5 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.25 g  in 5 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.25 g  in 5 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.15 g  in 5 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.15 g  in 5 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.135 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    C12-13 PARETH-3 (UNII: DMC6N3419L)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1217-81 in 1 PACKAGE06/02/2014
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/02/2014
    Labeler - Space Brands Limited (218214381)