sunscreen product listing

sunscreen product listing
SPL v3
SPL
SPL Set ID e91ded4b-987d-17a8-e053-2995a90adc2e
Route
topical
Published
Effective Date 2022-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (17 g)
Inactive Ingredients
c13-15 alkane polyglyceryl-3 diisostearate polyglyceryl-3 ricinoleate caprylyl glycol pongamia pinnata seed glycerin tasmannia lanceolata fruit mauritia flexuosa fruit oil polyhydroxystearic acid (2300 mw) water kunzea pomifera fruit syzygium luehmannii fruit caprylic/capric/linoleic triglyceride stearalkonium hectorite magnesium sulfate anhydrous phenylpropanol propanediol daucus carota subsp. sativus seed capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) panthenol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2022-09-22

Purpose

Sunscreen

Description

Active Ingredients Purpose Non-Nano uncoated Zinc Oxide, 17% Sunscreen


Medication Information

Warnings

Warnings:

  • For external use only
  • Do not use on damage or broken skin
  • When using the product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children, If product is swallowed, get medical help or contact a Poison Control Center right away.
Uses

  • Helps prevent sunburn
  • If used as directred with other sunprotection measures (See Directions).

Decrease the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions

Directions

  • Shake well
  • Apply Liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 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 specfgtrum of 15 or higher and other sun protection measures including:
  • Limit time in the sun, espcially from 10:00 am - 2:00 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor

Other Information

Other Information

  • Protecrt this product in this container from excessive heat and direct sun
Inactive Ingredients

Inactive Ingredients

Water, Caprylic/Capric Triglycerides, C13-15 Alkane, Caproyl Glycerin/Sebacic Acid Copolymer, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Daucus Carota Sativa Seed Oil, Polyhydroxystearic Acid, Phenylpropanol, Glycerin, Magnesium Sulfate, Propanediol, Caprylyl Glycol, Panthenol, Pongamia Pinnata seed Extract, Mauritia Flexousa Fruit Oil, Kunzea Pomifera Fruit Extract, Syzygium Luehmannii Fruit Extract, Tasmannia Lanceolata Fruit Extract, Tocophderol.

Description

Active Ingredients Purpose Non-Nano uncoated Zinc Oxide, 17% Sunscreen

Section 51945-4

LESSE

EVERY TONE SPF 30

Broad Spectrum Mineral Facial Sunscreen

Zinc Oxide & Australian Super Berries

Creme Solaire Minerale a Large Spectre

SPF 30 Contro Elementi Quotidiani

Mineralischer Breitband-Sonnenschutz

Solcreme| Minerale Zonnebrandcreme

Oxyde de zinc et plantes reparatrices

Do Not Use

Do not use on damage or broken skin

When Using This Product

When using this product keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

Stop use and ask a doctor if rash occurs

Active Ingredients Section

Active Ingredients Purpose

Non-Nano uncoated Zinc Oxide, 17% Sunscreen

Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact

Principal Display Panel Front of Package


Structured Label Content

Warnings

Warnings:

  • For external use only
  • Do not use on damage or broken skin
  • When using the product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children, If product is swallowed, get medical help or contact a Poison Control Center right away.
Uses

  • Helps prevent sunburn
  • If used as directred with other sunprotection measures (See Directions).

Decrease the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions

Directions

  • Shake well
  • Apply Liberally 15 minutes before sun exposure
  • Reapply:
  • After 40 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 specfgtrum of 15 or higher and other sun protection measures including:
  • Limit time in the sun, espcially from 10:00 am - 2:00 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor

Other Information

Other Information

  • Protecrt this product in this container from excessive heat and direct sun
Inactive Ingredients

Inactive Ingredients

Water, Caprylic/Capric Triglycerides, C13-15 Alkane, Caproyl Glycerin/Sebacic Acid Copolymer, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Daucus Carota Sativa Seed Oil, Polyhydroxystearic Acid, Phenylpropanol, Glycerin, Magnesium Sulfate, Propanediol, Caprylyl Glycol, Panthenol, Pongamia Pinnata seed Extract, Mauritia Flexousa Fruit Oil, Kunzea Pomifera Fruit Extract, Syzygium Luehmannii Fruit Extract, Tasmannia Lanceolata Fruit Extract, Tocophderol.

Section 51945-4 (51945-4)

LESSE

EVERY TONE SPF 30

Broad Spectrum Mineral Facial Sunscreen

Zinc Oxide & Australian Super Berries

Creme Solaire Minerale a Large Spectre

SPF 30 Contro Elementi Quotidiani

Mineralischer Breitband-Sonnenschutz

Solcreme| Minerale Zonnebrandcreme

Oxyde de zinc et plantes reparatrices

Do Not Use (Do not use)

Do not use on damage or broken skin

When Using This Product (When using this product)

When using this product keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if rash occurs

Active Ingredients Section

Active Ingredients Purpose

Non-Nano uncoated Zinc Oxide, 17% Sunscreen

Keep Out of Reach of Children (Keep out of reach of Children)

Keep out of reach of children. If product is swallowed, get medical help or contact

Principal Display Panel Front of Package


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)