foundation sunscreen face stick broad spectrum spf 38 kona gold

foundation sunscreen face stick broad spectrum spf 38 kona gold
SPL v1
SPL
SPL Set ID a9f5864b-d1fc-7a7a-e053-2a95a90a66a4
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) stearyl glycyrrhetinate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-04-02

Description

   Active ingredients              Purpose Titanium Dioxide 23%       Sunscreen


Medication Information

Warnings and Precautions

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

Active Ingredient

   Active ingredients              Purpose

Titanium Dioxide 23%       Sunscreen

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 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 value 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2p.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 children. If swallowed, get medical help or call 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, fragrance, Stearyl Glycyrrhetinate

Section 51945-4

Vertra Premium Suncare

SPF 38

Premium Mineral Based

Foundation Sunscreen Face Stick

Reef Safe

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color: Kona Gold

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

Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

   Active ingredients              Purpose

Titanium Dioxide 23%       Sunscreen

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 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 value 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or call 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, fragrance, Stearyl Glycyrrhetinate

Section 51945-4 (51945-4)

Vertra Premium Suncare

SPF 38

Premium Mineral Based

Foundation Sunscreen Face Stick

Reef Safe

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color: Kona Gold

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

Advanced Ingredient Data


Raw Label Data

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