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

DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION by

Drug Labeling and Warnings

DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION by is a Otc medication manufactured, distributed, or labeled by DOLCE & GABBANA BEAUTY SRL, INTERCOS EUROPE SPA, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 

Package Labeling:

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84003-041

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-041-01	1 in 1 KIT	05/01/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	0.6 mL
Part 2	1 BLISTER PACK	0.6 mL
Part 3	1 BLISTER PACK	0.6 mL
Part 4	1 BLISTER PACK	0.6 mL
Part 5	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-042-01	1 in 1 CARTON
1		0.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-043-01	1 in 1 CARTON
1		0.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-044-01	1 in 1 CARTON
1		0.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-045-01	1 in 1 CARTON
1		0.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84003-046-01	1 in 1 CARTON
1		0.6 mL in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2024

Labeler - DOLCE & GABBANA BEAUTY SRL (442254105)

Establishment
Name	Address	ID/FEI	Business Operations
INTERCOS EUROPE SPA		339447428	manufacture(84003-042, 84003-043, 84003-041, 84003-044, 84003-045, 84003-046)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(84003-042, 84003-043, 84003-041, 84003-044, 84003-045, 84003-046)