Foundation Sunscreen Face Stick Broad Spectrum Spf 35 Cooly Beige

Foundation Sunscreen Face Stick Broad Spectrum Spf 35 Cooly Beige
SPL v2
SPL
SPL Set ID fe241762-4236-4fbe-bceb-e2dc75a23bcb
Route
TOPICAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-07

Description

Active Ingredients                     Purpose Titanium Dioxide 23%           Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

  • Do not use on damaged or broken skin
  • When using this product  keep out of eyes
  • Rinse with water to remove
Indications and Usage

Stop use and ask a doctor if rash or irritation develops and lasts

Dosage and Administration

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to sun
  • use a water resistant sunscreen if swimming or sweating
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at leasty 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 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 of age: ask a doctor
Description

Active Ingredients                     Purpose Titanium Dioxide 23%           Sunscreen

Section 50565-1

Keep out of reach of chilcren. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 51945-4

Vertra Premium Suncare

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 35

Water Resistant (80 minutes)

Color: Cooly Beige

11g NET WT. .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 evenly 15 minutes before sun exposure
  • apply to all skin exposed to sun
  • use a water resistant sunscreen if swimming or sweating
  • reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at leasty 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 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 of age: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

  • Do not use on damaged or broken skin
  • When using this product  keep out of eyes
  • Rinse with water to remove
Section 50565-1 (50565-1)

Keep out of reach of chilcren. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Vertra Premium Suncare

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 35

Water Resistant (80 minutes)

Color: Cooly Beige

11g NET WT. .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)