Vertra Pearl White Face Stick Spf 50 +

Vertra Pearl White Face Stick Spf 50 +
SPL v6
SPL
SPL Set ID b7163861-7084-5adf-e053-2995a90ae199
Route
TOPICAL
Published
Effective Date 2020-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Padimate O (7 g) Titanium Dioxide (17 g)
Inactive Ingredients
Tocopherol Paraffin Hexyldecyl Isostearate Synthetic Wax (1200 Mw) Polyglyceryl-2 Oleate Aluminum Hydroxide Mica Ceresin Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-16

Description

Active Ingredients Purpose PADIMATE O 7% Sunscreen TITANIUM DIOXIDE 17% Sunscreen


Medication Information

Warnings and Precautions

Warnings

Do not use:

  • On damaged or broken skin

When using this product:

  • keep out of eyes. Rinse with water to remove
  • For external use only
Indications and Usage

Stop use and ask a doctor if:

Rash or irritation develops and lasts

Dosage and Administration

Directions

  • Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • 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 value of 15 or higher and other sun protection measures including:
  • limit your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Description

Active Ingredients Purpose PADIMATE O 7% Sunscreen TITANIUM DIOXIDE 17% Sunscreen

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 51727-6

Inactive Ingredients

Hexyldecyl Isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopherol, Fragrance

Section 51945-4

vertra

50 +

Pearl White Face Stick

Mineral Based Foundation

Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

10.5g NET WT 0.37 OZ

Section 55105-1

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
  • Provides high protection against sunburn
Section 55106-9

Active Ingredients Purpose

PADIMATE O 7% Sunscreen

TITANIUM DIOXIDE 17% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if:

Rash or irritation develops and lasts

Dosage and Administration (34068-7)

Directions

  • Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours
  • Children under 6 months of age: ask a doctor.
  • 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 value of 15 or higher and other sun protection measures including:
  • limit your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Warnings and Precautions (34071-1)

Warnings

Do not use:

  • On damaged or broken skin

When using this product:

  • keep out of eyes. Rinse with water to remove
  • For external use only
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 51727-6 (51727-6)

Inactive Ingredients

Hexyldecyl Isostearate, Mica, Synthetic Wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopherol, Fragrance

Section 51945-4 (51945-4)

vertra

50 +

Pearl White Face Stick

Mineral Based Foundation

Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

10.5g NET WT 0.37 OZ

Section 55105-1 (55105-1)

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
  • Provides high protection against sunburn
Section 55106-9 (55106-9)

Active Ingredients Purpose

PADIMATE O 7% Sunscreen

TITANIUM DIOXIDE 17% Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)