Label: DOLCE AND GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION- octisalate, octocrylene, titanium dioxide, zinc oxide kit

  • NDC Code(s): 84003-041-01, 84003-042-01, 84003-043-01, 84003-044-01, view more
    84003-045-01, 84003-046-01
  • Packager: DOLCE & GABBANA BEAUTY SRL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Octisalate 3.5%

    Octocrylene 5%

    Titanium dioxide 0.5%

    Zinc Oxide 1.88%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If uses directed with others 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

    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 generously 15 minutes before sun exposure
    • 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 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.- 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses 
    • Children under 6 months of age: ask a doctor

    SHAKE WELL BEFORE USE

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    WATER/EAU (AQUA), DIMETHICONE, CAPRYLYL METHICONE, TRIMETHYLSILOXYSILICATE, METHYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BUTYLENE GLYCOL, PEG-10 DIMETHICONE, PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, POLYIMIDE-1, CETEARYL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYPHENYLSILSESQUIOXANE, PHENOXYETHANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, SODIUM CHLORIDE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, ALUMINA, TRIETHOXYCAPRYLSILANE, C20-24 OLEFIN, SILICA, TOCOPHERYL ACETATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PUNICA GRANATUM PERICARP EXTRACT, LAURYL DIMETHICONE, OPUNTIA TUNA FRUOT EXTRACT, TOCOPHEROL; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499) 

  • Package Labeling: 

    KitKit2

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    DOLCE AND GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION 
    octisalate, octocrylene, titanium dioxide, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84003-041
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-041-011 in 1 KIT05/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 0.6 mL
    Part 21 BLISTER PACK 0.6 mL
    Part 31 BLISTER PACK 0.6 mL
    Part 41 BLISTER PACK 0.6 mL
    Part 51 BLISTER PACK 0.6 mL
    Part 1 of 5
    DOLCE AND GABBANA EVERLAST FOUNDATION - 5N 
    octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:84003-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE (UNII: DAC8GQQ57F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AVOCADO (UNII: SDS87L369F)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    OPUNTIA TUNA FRUIT (UNII: 75UY509K9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-042-011 in 1 CARTON
    10.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Part 2 of 5
    DOLCE AND GABBANA EVERLAST FOUNDATION - 12N 
    octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:84003-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE (UNII: DAC8GQQ57F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AVOCADO (UNII: SDS87L369F)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    OPUNTIA TUNA FRUIT (UNII: 75UY509K9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-043-011 in 1 CARTON
    10.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Part 3 of 5
    DOLCE AND GABBANA EVERLAST FOUNDATION - 19W 
    octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:84003-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE (UNII: DAC8GQQ57F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AVOCADO (UNII: SDS87L369F)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    OPUNTIA TUNA FRUIT (UNII: 75UY509K9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-044-011 in 1 CARTON
    10.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Part 4 of 5
    DOLCE AND GABBANA EVERLAST FOUNDATION - 28W 
    octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:84003-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE (UNII: DAC8GQQ57F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AVOCADO (UNII: SDS87L369F)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    OPUNTIA TUNA FRUIT (UNII: 75UY509K9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-045-011 in 1 CARTON
    10.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Part 5 of 5
    DOLCE AND GABBANA EVERLAST FOUNDATION - 36N 
    octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Item Code (Source)NDC:84003-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE (UNII: DAC8GQQ57F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AVOCADO (UNII: SDS87L369F)  
    POMEGRANATE FRUIT RIND (UNII: RS999V57DU)  
    OPUNTIA TUNA FRUIT (UNII: 75UY509K9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84003-046-011 in 1 CARTON
    10.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2024
    Labeler - DOLCE & GABBANA BEAUTY SRL (442254105)
    Establishment
    NameAddressID/FEIBusiness Operations
    INTERCOS EUROPE SPA339447428manufacture(84003-042, 84003-043, 84003-041, 84003-044, 84003-045, 84003-046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Socoplan276221405pack(84003-042, 84003-043, 84003-041, 84003-044, 84003-045, 84003-046)