Label: EVE LOM FLAWLESS RADIANCE PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octisalate, octocrylene, oxybenzone and avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 14, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active Ingredients           Purpose

    Octinoxate 6.7%                Sunscreen

    Octisalate 4.5%                 Sunscreen

    Octocrylene 4.5%              Sunscreen

    Oxybenzone 3%                Sunscreen

    Avobenzone 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 of 15 of 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, glycerin, ethylhexyl methoxycrylene, cetearyl alcohol, niacinamide, dimethicone, nylon-12, glyceryl stearate, vp/eicosene copolymer, phenoxyethanol, caprylic/capric triglyceride, potassium behenoyl hydroxyproline, polysilicone-11, ethylhexylhlycerin, sodium carbomer, chlorphenesin, xanthan gum, mica, tocopheryl acetate, behenic acid, disodium edta, squalane, sodium hyaluronate, pancratium maritimum extract, rosa centifolia flower extract, rubus idaeus leaf cell culture, titanium dioxide (CI 77891).

  • Other information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 50 mL CARTONEVE LOMFLAWLESS RADIANCE PRIMERBROAD SPECTRUM SPF 30 SUNSCREEN50 mL 1.7 FL. OZ e

    image description

  • INGREDIENTS AND APPEARANCE
    EVE LOM FLAWLESS RADIANCE PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN 
    octinoxate, octisalate, octocrylene, oxybenzone and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.35 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.25 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.50 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.35 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NYLON-12 (UNII: 446U8J075B)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM BEHENOYL HYDROXYPROLINE (UNII: 82EPB0Q5XG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BEHENIC ACID (UNII: H390488X0A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SQUALANE (UNII: GW89575KF9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1250-31 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2014
    Labeler - Space Brands Limited (218214381)
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