FDA.reportPublic FDA data

PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN

Manufacturer
ELIZABETH ARDEN, INC
Effective date
2017-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:47

Label at a glance#

ProductPRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 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

Titanium Dioxide 6.1 % 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:

SPL UNCLASSIFIED 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, ISODODECANE, C12-15 ALKYL BENZOATE, CAPRYLYL METHICONE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, RICINOLETH-40, ETHOXYDIGLYCOL, CARNOSINE, ACETYL FARNESYLCYSTEINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ALLYL CAPROATE, ARABIDOPSIS THALIANA EXTRACT, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CHONDRUS CRISPUS EXTRACT, DIPROPYLENE GLYCOL, ERGOTHIONEINE, ETHYL DECADIENOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROGEN DIMETHICONE, LECITHIN, METHYLDIHYDROJASMONATE, METHYLENEDIOXYPHENYL METHYLPROPANAL, MICROCOCCUS LYSATE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SILICA, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499).

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 1-844-273-3679

Principal Display Panel - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)

Principal Display Panel - Bottle Label
Principal Display Panel - Bottle Label

Principal Display Panel - Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR

Broad Spectrum
SPF 50 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

PHYSICAL SUNSCREEN
UNIVERSAL TINT

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

1.7 FL. OZ. (50 ml)

Principal Display Panel - Carton Label
Principal Display Panel - Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2075-12020-09-27C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts
67938-2075-12020-09-25C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts
67938-2075-12020-07-22C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2075-1PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 BOXLOTION11
67938-2075-2PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2075PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170210_6b1920aa-ec6a-4c8b-b8b8-2c621f959e94.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-207567938-2075-2, 67938-2075-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISODODECANEA8289P68Y2IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PENTYLENE GLYCOL50C1307PZGIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
RICINOLETH-406S0J4W9IQYIACT
CARNOSINE8HO6PVN24WIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ACETYL FARNESYLCYSTEINEKK6984C8O3IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CHLORPHENESINI670DAL4SZIACT
FERRIC OXIDE RED1K09F3G675IACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
ALLYL HEXANOATE3VH84A363DIACT
ETHYL 2,4-DECADIENOATE, (2E,4Z)-79P6KS9Y5ZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANALL65EG8H6PAIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ARABIDOPSIS THALIANAAI3L60HQ81IACT

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
9f92c5e4-8317-4a87-a581-8f81204b5e286b1920aa-ec6a-4c8b-b8b8-2c621f959e942017-02-01WarningsExact identifier
spl id: 9f92c5e4-8317-4a87-a581-8f81204b5e28
spl set id: 6b1920aa-ec6a-4c8b-b8b8-2c621f959e94

Reported adverse events (FAERS/openFDA)#

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