FDA.reportPublic FDA data

PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 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 22:49:05

Label at a glance#

ProductPRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN
Active ingredientOCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
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

OCTINOXATE 7.5 % W/W

OXYBENZONE 5.0 % W/W

OCTISALATE 5.0 % W/W

OCTOCRYLENE 5.0 % W/W

AVOBENZONE 3.0 % W/W

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

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, NYLON-12, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, PENTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLYL METHICONE, ACETYL FARNESYLCYSTEINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAPRYLYL GLYCOL, CARNOSINE, CETETH-20 PHOSPHATE, CHONDRUS CRISPUS EXTRACT, COCO-GLUCOSIDE, DICETYL PHOSPHATE, DISODIUM EDTA, ERGOTHIONEINE, HYDROXYACETOPHENONE, LECITHIN, MICROCOCCUS LYSATE, PLANKTON EXTRACT, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE.

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
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 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
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 ml)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2076-12020-09-27C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts
67938-2076-12020-09-25C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts
67938-2076-12020-07-22C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2076-1PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN1 in 1 BOXLOTION11
67938-2076-2PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN120 mL in 1 BOTTLELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2076PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170302_e4ec1f6d-8440-43f7-9263-ee969901d09d.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
67938-207667938-2076-2, 67938-2076-1

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
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
NYLON-12446U8J075BIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PENTYLENE GLYCOL50C1307PZGIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETETH-20 PHOSPHATE921FTA1500IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
COCO GLUCOSIDEICS790225BIACT
CARNOSINE8HO6PVN24WIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHLORPHENESINI670DAL4SZIACT
ACETYL FARNESYLCYSTEINEKK6984C8O3IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARABIDOPSIS THALIANAAI3L60HQ81IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
ERGOTHIONEINEBDZ3DQM98WIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
f3a05263-83a8-42c9-b7d9-cf12e8bbc40fe4ec1f6d-8440-43f7-9263-ee969901d09d2017-02-01WarningsExact identifier
spl id: f3a05263-83a8-42c9-b7d9-cf12e8bbc40f
spl set id: e4ec1f6d-8440-43f7-9263-ee969901d09d

Reported adverse events (FAERS/openFDA)#

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