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round lab
SPL v1
SPL
SPL Set ID 1e7cc417-3c57-c87c-e063-6394a90a670b
Route
topical
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (17 g)
Inactive Ingredients
polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) artemisia annua leaf hyaluronate sodium triethoxycaprylylsilane cryptomeria japonica leaf ascorbic acid water propylheptyl caprylate disteardimonium hectorite butylene glycol butyloctyl salicylate cyclomethicone 6 methyl trimethicone caprylyl trisiloxane 1,2-hexanediol polyglyceryl-2 dipolyhydroxystearate caprylyl glycol ethylhexylglycerin pine needle oil (pinus sylvestris) isododecane chamaemelum nobile flower oil polymethylsilsesquioxane (4.5 microns) betula platyphylla var. japonica resin glyceryl caprylate nelumbo nucifera leaf saccharomyces cerevisiae tocopherol propanediol methyl methacrylate/glycol dimethacrylate crosspolymer magnesium sulfate, unspecified glycerin glyceryl glucoside hyaluronic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-08-13

Description

Active Ingredients Zinc Oxide 17%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Active Ingredient

Active Ingredients

Zinc Oxide 17%

Indications and Usage

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.
Dosage and Administration

Directions

  • apply liberally and evenly 15 minutes before sun exposure.
  • Sun protection measures.

Spending time in the sun increases your risk of skin cancer and early 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 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 at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating
Description

Active Ingredients Zinc Oxide 17%

Section 42229-5

Other Information

  • protect the product from excessive heat and direct sun
Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive ingredients

Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid

Section 51945-4

BIRCH JUICE

MILD-UP UVLOCK

SUNSCREEN

SPF50+ Broad spectrum

ROUND LAB

50nL 1.69fl. oz.

Section 53413-1

Questions or comments?

www.roundlab.com

Section 55105-1

Purpose

Sunscreen


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredients

Zinc Oxide 17%

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

Directions

  • apply liberally and evenly 15 minutes before sun exposure.
  • Sun protection measures.

Spending time in the sun increases your risk of skin cancer and early 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 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 at least every 2 hours.
  • use a water-resistant sunscreen if swimming or sweating
Section 42229-5 (42229-5)

Other Information

  • protect the product from excessive heat and direct sun
Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid

Section 51945-4 (51945-4)

BIRCH JUICE

MILD-UP UVLOCK

SUNSCREEN

SPF50+ Broad spectrum

ROUND LAB

50nL 1.69fl. oz.

Section 53413-1 (53413-1)

Questions or comments?

www.roundlab.com

Section 55105-1 (55105-1)

Purpose

Sunscreen


Advanced Ingredient Data


Raw Label Data

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