FDA.reportPublic FDA data

OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE

Manufacturer
DOLCE & GABBANA BEAUTY SRL | Socoplan | INTERCOS EUROPE SPA
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:40:43

Label at a glance#

ProductDOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION
Active ingredientOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 3.5%

Octocrylene 5%

Titanium dioxide 0.5%

Zinc Oxide 1.88%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 LABEL.PRINCIPAL DISPLAY PANEL

KitKitKit2Kit2

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeworld.dolcegabbana.com/how-to-recycle-beauty-packKit.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84003-041-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 KITKIT12
84003-042-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 CARTONEMULSION50 mg in 1mL2
84003-042-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION0.6 mL in 1 BLISTER PACKEMULSION0.6 mL35 mg in 1mL2
84003-043-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION0.6 mL in 1 BLISTER PACKEMULSION0.6 mL35 mg in 1mL2
84003-043-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 CARTONEMULSION18.8 mg in 1mL2
84003-044-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION0.6 mL in 1 BLISTER PACKEMULSION0.6 mL18.8 mg in 1mL2
84003-044-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 CARTONEMULSION50 mg in 1mL2
84003-045-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION0.6 mL in 1 BLISTER PACKEMULSION0.6 mL50 mg in 1mL2
84003-045-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 CARTONEMULSION50 mg in 1mL2
84003-046-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION0.6 mL in 1 BLISTER PACKEMULSION0.6 mL35 mg in 1mL2
84003-046-01DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION1 in 1 CARTONEMULSION5 mg in 1mL2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84003-04284003-042-01
84003-04384003-043-01
84003-04184003-041-01
84003-04484003-044-01
84003-04584003-045-01
84003-04684003-046-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 130 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER965K72OQXOIACT
CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDEDAC8GQQ57FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
ALUMINUM OXIDELMI26O6933IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOCADOSDS87L369FIACT
POMEGRANATE FRUIT RINDRS999V57DUIACT
OPUNTIA TUNA FRUIT75UY509K9BIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER965K72OQXOIACT
CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDEDAC8GQQ57FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-03-07full-release2026-06-01 00:11:50

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATIONOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDOLCE & GABBANA BEAUTY SRLeb63e9c6-bdb0-4bdf-8822-e4561a56adc92025-09-03WarningsExact identifier
ndc (package): 84003-042-01
ndc (package): 84003-045-01
ndc (package): 84003-043-01
ndc (package): 84003-046-01
ndc (package): 84003-044-01
ndc (package): 84003-041-01
ndc (product): 84003-041
ndc11 (package): 84003004401
ndc11 (package): 84003004601
ndc11 (package): 84003004201
ndc11 (package): 84003004501
ndc11 (package): 84003004301
ndc11 (package): 84003004101
spl id: 3deea45d-6c4d-8ae8-e063-6394a90ae036
spl set id: eb63e9c6-bdb0-4bdf-8822-e4561a56adc9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.