EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE) CREAM [SPACE BRANDS LIMITED]

EVE LOM DAILY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE) CREAM [SPACE BRANDS LIMITED]
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NDC 61601-1217-8
Set ID 0e2c9ffb-036d-49c5-abdb-2ee8888df318
Category HUMAN OTC DRUG LABEL
Packager Space Brands Limited
Generic Name
Product Class
Product Number
Application Number PART352
  • 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)

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