FDA.reportPublic FDA data

ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD

Manufacturer
ELIZABETH ARDEN, INC
Effective date
2017-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:22

Label at a glance#

ProductELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 6.2% W/W

ZINC OXIDE 5.6% W/W

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other 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

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 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 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
  • Children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • Store at room temperature

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800 326-7337

Principal Display Panel - Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prevage®

city smart

+ DNA enzyme complex™

+ anti-pollution

+ antioxidants

broad spectrum SPF 50

hydrating shield

1.34 FL. OZ. 40 ml

Principal Display Panel - Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield
Principal Display Panel - Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-3050-12021-01-29C16284748780-1ba0f9c33-3717-a910-e053-dadaa90a0b85Drug Facts
67938-3050-22021-01-29C16284748780-1ba0f9c33-3717-a910-e053-dadaa90a0b85Drug Facts
67938-3050-32021-01-29C16284748780-1ba0f9c33-3717-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-3050-1ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD1 in 1 CARTONLOTION11
67938-3050-1ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD5 mL in 1 TUBELOTION51
67938-3050-2ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD40 mL in 1 TUBELOTION401
67938-3050-2ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD1 in 1 CARTONLOTION11
67938-3050-3ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD15 mL in 1 TUBELOTION151
67938-3050-3ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-3050ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 6 package rows20170830_cce10ecc-6231-41ac-b85c-33c342e65cdb.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-305067938-3050-1, 67938-3050-2, 67938-3050-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PENTYLENE GLYCOL50C1307PZGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
CARNOSINE8HO6PVN24WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MICAV8A1AW0880IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
EDETATE DISODIUM7FLD91C86KIACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERULIC ACIDAVM951ZWSTIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
STANNIC OXIDEKM7N50LOS6IACT
ARABIDOPSIS THALIANAAI3L60HQ81IACT
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATEOV1BT2N8RCIACT
ERGOTHIONEINEBDZ3DQM98WIACT
ISODODECANEA8289P68Y2IACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
4ddbb2b5-162a-4463-a7bd-9a71991ce1bbcce10ecc-6231-41ac-b85c-33c342e65cdb2017-08-01WarningsExact identifier
spl id: 4ddbb2b5-162a-4463-a7bd-9a71991ce1bb
spl set id: cce10ecc-6231-41ac-b85c-33c342e65cdb

Reported adverse events (FAERS/openFDA)#

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