EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 (TITANIUM DIOXIDE AND OCTINOXATE) CREAM [SPACE BRANDS LIMITED]

EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 (TITANIUM DIOXIDE AND OCTINOXATE) CREAM [SPACE BRANDS LIMITED]
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NDC 61601-1193-9, 61601-1194-8, 61601-1195-8, 61601-1196-7
Set ID 6977c06f-d7f0-4f3b-b800-beecb5ebf81c
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

    Active IngredientsPurpose
    Octinoxate 5%Sunscreen
    Titanium Dioxide 6.2%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measure (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

    • 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 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, dimethicone, c 12-15 alkly benzoate, propylene glycol dicaprylate/dicaprate, glycerin, isododecane, butylene glycol, silica, talc, cetyl PEG/PPG-10/1 dimethicone, synthetic beeswax, polyglyceryl-3 diisostearate, sodium chloride, phenoxyethanol, zinc stearate, caprylic/capric triglyceride, disodium EDTA, disteardimonium hectorite, triethoxycaprylylsilane, sodium dehydroacetate, chlorphenesin, tocopheryl acetate, alcohol, ascorbyl palmitate, aluminum hydroxide, sodium hyaluronate, pancratium maritimum extract, rubus idaeus leaf cell culture.

    May contain: titanium dioxide, iron oxides.

  • Other information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Ivory 2

    EVE
    LOM®

    RADIANCE PERFECTED
    TINTED MOISTURISER
    BROAD SPECTRUM SPF 15
    SUNSCREEN
    IVORY 2

    50ml 1.7 FL. OZ. e

    Principal Display Panel - 50 ml Tube Carton - Ivory 2
  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Beige 7

    EVE
    LOM®

    RADIANCE PERFECTED
    TINTED MOISTURISER
    BROAD SPECTRUM SPF 15
    SUNSCREEN
    BEIGE 7

    50ml 1.7 FL. OZ. e

    Principal Display Panel - 50 ml Tube Carton - Beige 7
  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Bamboo 10

    EVE
    LOM®

    RADIANCE PERFECTED
    TINTED MOISTURISER
    BROAD SPECTRUM SPF 15
    SUNSCREEN
    BAMBOO 10

    50ml 1.7 FL. OZ. e

    Principal Display Panel - 50 ml Tube Carton - Bamboo 10
  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - Honey 12

    EVE
    LOM®

    RADIANCE PERFECTED
    TINTED MOISTURISER
    BROAD SPECTRUM SPF 15
    SUNSCREEN
    HONEY 12

    50ml 1.7 FL. OZ. e

    Principal Display Panel - 50 ml Tube Carton - Honey 12
  • INGREDIENTS AND APPEARANCE
    EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1193
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isododecane (UNII: A8289P68Y2)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Talc (UNII: 7SEV7J4R1U)  
    Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Sodium Dehydroacetate (UNII: 8W46YN971G)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Alcohol (UNII: 3K9958V90M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorWHITE (Ivory 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1193-91 in 1 CARTON
    12 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/28/2014
    EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1194
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isododecane (UNII: A8289P68Y2)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Talc (UNII: 7SEV7J4R1U)  
    Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Sodium Dehydroacetate (UNII: 8W46YN971G)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Alcohol (UNII: 3K9958V90M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorBROWN (Biege 7) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1194-81 in 1 CARTON
    12 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/28/2014
    EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1195
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isododecane (UNII: A8289P68Y2)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Talc (UNII: 7SEV7J4R1U)  
    Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Sodium Dehydroacetate (UNII: 8W46YN971G)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Alcohol (UNII: 3K9958V90M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorBROWN (Bamboo 10) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1195-81 in 1 CARTON
    12 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/28/2014
    EVE LOM RADIANCE PERFECTED TINTED MOISTURISER SPF 15 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.1 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate2.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isododecane (UNII: A8289P68Y2)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Talc (UNII: 7SEV7J4R1U)  
    Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)  
    Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Sodium Dehydroacetate (UNII: 8W46YN971G)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Alcohol (UNII: 3K9958V90M)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorBROWN (Honey 12) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1196-71 in 1 CARTON
    12 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/28/2014
    Labeler - Space Brands Limited (218214381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intercos Europe S.p.A.438961310MANUFACTURE(61601-1193, 61601-1194, 61601-1195, 61601-1196)

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