Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3a98117a-900c-43c0-aa91-b77250348a7b
Route
TOPICAL
Published
Effective Date 2017-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1 g)
Inactive Ingredients
Mica Green Tea Leaf Vitis Vinifera Seed Cocoa Acai Turmeric Titanium Dioxide Bismuth Oxychloride Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-01

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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
Section 50565-1
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin
Warnings
  • For external use only
Other Information
  • Protect this product from excessive heat and direct sun
  • Store at room temperature
Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

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).

Questions Or Comments?

Call toll free 1-844-273-3679

Directions for Sunscreen Use:
  • 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.
Principal Display Panel Jar Label

LIFT HERE

ElizabethArden

PRO

PERFECTING MINERALS

BROAD SPECTRUM SPF 25 SUNSCREEN

Powder with Tx-Botanical Complex™

SHADE 4

RECOMMENDED

SKIN

CANCER

FOUNDATION

DAILY USE

RECOMMENDED AS

AN EFFECTIVE

BROAD SPECTRUM

SUNSCREEN


Structured Label Content

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
Section 50565-1 (50565-1)
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Purpose

Sunscreen

Warnings
  • For external use only
Other Information
  • Protect this product from excessive heat and direct sun
  • Store at room temperature
Active Ingredients

Zinc Oxide 20%

Inactive Ingredients

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).

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-273-3679

Directions for Sunscreen Use:
  • 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.
Principal Display Panel Jar Label (Principal Display Panel - Jar Label)

LIFT HERE

ElizabethArden

PRO

PERFECTING MINERALS

BROAD SPECTRUM SPF 25 SUNSCREEN

Powder with Tx-Botanical Complex™

SHADE 4

RECOMMENDED

SKIN

CANCER

FOUNDATION

DAILY USE

RECOMMENDED AS

AN EFFECTIVE

BROAD SPECTRUM

SUNSCREEN


Advanced Ingredient Data


Raw Label Data

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