MedPath

Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep

Dolce & Gabbana Everlast Foundation SPF 20 - 31N Medium Deep

Approved
Approval ID

c89e45d6-2322-4913-a557-e1780a86fd63

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 11, 2025

Manufacturers
FDA

Dolce & Gabbana Beauty S.R.L

DUNS: 442254105

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84003-031
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 11, 2025
FDA Product Classification

INGREDIENTS (26)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CAPRYLYL TRISILOXANEInactive
Code: Q95M2P1KJL
Classification: IACT
METHYL TRIMETHICONEInactive
Code: S73ZQI0GXM
Classification: IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive
Code: 59Z907ZB69
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMERInactive
Code: 965K72OQXO
Classification: IACT
CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDEInactive
Code: DAC8GQQ57F
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SODIUM DEHYDROACETATEInactive
Code: 8W46YN971G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
AVOCADOInactive
Code: SDS87L369F
Classification: IACT
POMEGRANATE FRUIT RINDInactive
Code: RS999V57DU
Classification: IACT
OPUNTIA TUNA FRUITInactive
Code: 75UY509K9B
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
OCTISALATEActive
Quantity: 35 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 50 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
TITANIUM DIOXIDEActive
Quantity: 5 mg in 1 mL
Code: 15FIX9V2JP
Classification: ACTIB
ZINC OXIDEActive
Quantity: 18.8 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/3/2024

Package labelling:

Tester 31N.jpgShade31.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/17/2024

Uses

  • Helps prevent sunburn
  • If uses directed with others sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/17/2024

Other Information

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/18/2024

Active ingredients

Octisalate 3.5%

Octocrylene 5%

Titanium dioxide 0.5%

Zinc Oxide 1.88%

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 1/17/2024

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/17/2024

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/17/2024

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, TRIETHOXYCAPRYLYLSILANE, C20-24 OLEFIN, SILICA, TOCOPHERYL ACETATE, PERSEA GRATISSIMA (AVOCADO) FRUIT EXTRACT, PUNICA GRANATUM PERICARP EXTRACT, LAURYL DIMETHICONE, OPUNTIA TUNA FRUIT EXTRACT, TOCOPHEROL; +/- MAY CONTAIN: TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep - FDA Drug Approval Details