FDA.reportPublic FDA data

PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 3

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 22:49:01

Label at a glance#

ProductPRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 3
Active ingredientZINC 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

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

MICA, CAMELLIA SINENSIS LEAF EXTRACT, CHLOROGENIC ACIDS, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, THEOBROMA CACAO (COCOA) SEED POWDER, VITIS VINIFERA (GRAPE) SEED EXTRACT [MAY CONTAIN/PEUT CONTENIR (+/-) BISMUTH OXYCHLORIDE (CI 77163), 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 1-844-273-3679

Principal Display Panel - Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIFT HERE

ElizabethArden

PRO

PERFECTING MINERALS

BROAD SPECTRUM SPF 25 SUNSCREEN

Powder with Tx-Botanical Complex™

SHADE 5

RECOMMENDED

SKIN
CANCER
FOUNDATION

DAILY USE

RECOMMENDED AS
AN EFFECTIVE
BROAD SPECTRUM
SUNSCREEN

Principal Display Panel - Jar Label
Principal Display Panel - Jar Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2081-12021-01-29C16284748780-1ba0f9c33-182f-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2081-1PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 31 in 1 BOXLOTION11
67938-2081-1PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 35 g in 1 JARLOTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2081PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 3 (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170302_3190768e-1a70-4021-8050-160e2910b9f8.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-208167938-2081-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
MICAV8A1AW0880IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
COCOAD9108TZ9KGIACT
ACAI46AM2VJ0AWIACT
TURMERIC856YO1Z64FIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
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
95ac57f7-efd7-421a-b3a2-18cce03561d43190768e-1a70-4021-8050-160e2910b9f82017-02-01WarningsExact identifier
spl id: 95ac57f7-efd7-421a-b3a2-18cce03561d4
spl set id: 3190768e-1a70-4021-8050-160e2910b9f8

Reported adverse events (FAERS/openFDA)#

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