FDA.reportPublic FDA data

ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30

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 22:52:21

Label at a glance#

ProductELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 6.0%

TITANIUM DIOXIDE 6.0%

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

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, MYRISTYL TRISILOXANE, POLYMETHYLSILSESQUIOXANE, CYCLOHEXASILOXANE, SORBITAN ISOSTEARATE, ALUMINA, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, GLYCERIN, TETRAHEXYLDECYL ASCORBATE, TRIMETHYLSILOXYSILICATE, MICA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, CAMELLIA SINENSIS LEAF EXTRACT, CARNOSINE, DIMETHICONE, DIMETHICONOL, DISODIUM COCOYL GLUTAMATE, ERGOTHIONEINE, FERULIC ACID, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, PARFUM/FRAGRANCE, PCA DIMETHICONE, POLYHYDROXYSTEARIC ACID, SILICA, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM COCOYL GLUTAMATE, STEARIC ACID, TOCOPHEROL, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, 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

Questions or comments?

OTC - QUESTIONS SECTION

  • Call toll free 1-800 326-7337

Principal Display Panel - Prevage Anti-Aging Foundation Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prevage®

anti-aging foundation

broad spectrum sunscreen

SPF 30

1 FL. OZ. 30 ml

Principal Display Panel - Prevage Anti-Aging Foundation Carton Label
Principal Display Panel - Prevage Anti-Aging Foundation Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-3051-12021-01-29C16284748780-1ba0f9c33-557c-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-3051-1ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 3030 mL in 1 BOTTLELOTION301
67938-3051-1ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-3051ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170830_29e146f8-0c58-4dc5-a05c-c364f166df48.zip

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
67938-305167938-3051-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
MYRISTYL TRISILOXANEJ7960S4R1TIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
MICAV8A1AW0880IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARNOSINE8HO6PVN24WIACT
DIMETHICONE92RU3N3Y1OIACT
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT
ERGOTHIONEINEBDZ3DQM98WIACT
FERULIC ACIDAVM951ZWSTIACT
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATEOV1BT2N8RCIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
03adbd91-6e02-4eda-b1fc-5b7e7c444f5a29e146f8-0c58-4dc5-a05c-c364f166df482017-08-01WarningsExact identifier
spl id: 03adbd91-6e02-4eda-b1fc-5b7e7c444f5a
spl set id: 29e146f8-0c58-4dc5-a05c-c364f166df48

Reported adverse events (FAERS/openFDA)#

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