Vertra S Dorian Kona Gold Signature Face Stick Spf 38

Vertra S Dorian Kona Gold Signature Face Stick Spf 38
SPL v4
SPL
SPL Set ID b7162a2f-07f1-6188-e053-2995a90a8a9c
Route
TOPICAL
Published
Effective Date 2020-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (23 g)
Inactive Ingredients
Mica Ferrosoferric Oxide Paraffin Ceresin Stearic Acid Tocopherol Ferric Oxide Red Ferric Oxide Yellow Synthetic Wax (1200 Mw) Polyglyceryl-2 Oleate Hexyldecyl Isostearate Aluminum Hydroxide Stearyl Glycyrrhetinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-18

Description

Active Ingredients Purpose TITANIUM DIOXIDE 23% 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 and at least every 2 hours.

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

•Children under 6 months of age: ask a doctor

Reapply:

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

Description

Active Ingredients Purpose TITANIUM DIOXIDE 23% 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, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate

Section 51945-4

Kona Gold

vertra

38

Mineral Based Foundation

Broad Spectrum SPF 38

Water Resistant (80 minutes)

11g NET WT. 0.39 OZ

Section 55105-1

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
  • 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

TITANIUM DIOXIDE 23% 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 and at least every 2 hours.

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

•Children under 6 months of age: ask a doctor

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, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate

Section 51945-4 (51945-4)

Kona Gold

vertra

38

Mineral Based Foundation

Broad Spectrum SPF 38

Water Resistant (80 minutes)

11g NET WT. 0.39 OZ

Section 55105-1 (55105-1)

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
  • 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

TITANIUM DIOXIDE 23% Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)