EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN (TITANIUM DIOXIDE AND OCTINOXATE) CREAM [SPACE BRANDS LIMITED]

EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN (TITANIUM DIOXIDE AND OCTINOXATE) CREAM [SPACE BRANDS LIMITED]
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NDC 61601-1139-9, 61601-1140-1, 61601-1141-3, 61601-1142-2, 61601-1143-2, 61601-1144-0
Set ID 2e3dbc7d-d7e1-4808-ae49-8a63362af241
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 Ingredients                     Purpose

    Octinoxate 3.9%                        Sunscreen

    Titanium Dioxide 4%                  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

    Do not use on damages 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.

  • DOSAGE & ADMINISTRATION

    • 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

    ethylhexyl stearate, isononyl isononanoate, tribehenin, talc, caprylic/capric triglyceride, hydrogenated coco-glycerides, stearalkonium bentonite, hydrogenated polyisobutene, propylene carbonate, hydrogenated vegetable oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, nylon-12 fluorescent brightener 230 salt, hydrogenated styrene/isoprene copolymer, crithmum maritimum extract, polyvinylalcohol crosspolymer, BHT, 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 - 2 g Container Carton - Alabaster

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    ALABASTER 1

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Alabaster

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Ivory

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    IVORY 2

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Ivory

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Linen

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    LINEN 4

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Linen

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Beige

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    BEIGE 3

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Beige

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Wheat

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    WHEAT 5

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Wheat

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Glow

    EVE LOM®

    BRILLIANT COVER CONCEALER

    BROAD SPECTRUM SPF 15

    SUNSCREEN

    GLOW 6

    net wt 2g 0.07 OZ

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Glow

  • INGREDIENTS AND APPEARANCE
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorwhite (Alabaster) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1139-91 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorwhite (Ivory) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1140-11 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorbrown (Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1141-31 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorwhite (Linen) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1142-21 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorbrown (Wheat) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1143-21 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    EVE LOM BRILLIANT COVER CONCEALER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide and octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61601-1144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.078 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    TALC (UNII: 7SEV7J4R1U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Colorbrown (Glow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61601-1144-01 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2014
    Labeler - Space Brands Limited (218214381)

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