Round Lab

Round Lab
SPL v1
SPL
SPL Set ID 26442417-f238-1fc3-e063-6394a90a6f82
Route
TOPICAL
Published
Effective Date 2025-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octisalate (4.5 g) Homosalate (9.5 g) Avobenzone (3 g)
Inactive Ingredients
Diethylhexyl Carbonate Dimethicone Synthetic Wax (1200 Mw) Diphenylsiloxy Phenyl Trimethicone Butyloctyl Salicylate Isopropyl Palmitate Phenethyl Benzoate Diisostearyl Malate Ethylhexyl Isononanoate Caprylyl Trimethicone Magnesium Potassium Aluminosilicate Fluoride Bis-behenyl/isostearyl/phytosteryl Dimer Dilinoleyl Dimer Dilinoleate Polymethylsilsesquioxane Polyethylene Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Camellia Japonica Seed Oil Silica Dimethyl Silylate Dimethicone Crosspolymer Artemisia Annua Leaf Carnauba Wax Anthemis Nobilis Flower Oil Water Dipotassium Glycyrrhizate Allantoin Glyceryl Glucoside Butylene Glycol Glycerin 1,2-hexanediol Betula Platyphylla Japonica Juice Ulmus Davidiana Root Aloe Vera Leaf Viola Mandshurica Flower Laminaria Japonica Glyceryl Caprylate Hyaluronic Acid Ascorbic Acid Candelilla Wax Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Sodium Hyaluronate Pinus Sylvestris Leaf Oil Dioscorea Japonica Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-06

Description

Homosalate 9.5% Octocrylene 5% Octisalate 4.5% Avobenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.5% Octocrylene 5% Octisalate 4.5% Avobenzone 3%

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.

Section 50565-1

Keep out of reach of children

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 51945-4

BIRCH JUICE MOISTURIZING

UVLOCK SUN STICK

SUN STICK

SPF50+ Broad Spectrum

ROUND LAB

19g 0.67 oz.

Section 60561-8

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

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

Directions
  • reapply at least every 2 hours.
  • apply liberally 15 minutes before sun exposure.
  • use a water-resistant sunscreen if swimming or sweating.

• 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 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
Other Information

protect the product from excessive heat and direct sun

Active Ingredients

Homosalate 9.5%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 3%

Inactive Ingredients

Diethylhexyl Carbonate, Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diphenylsiloxy Phenyl Trimethicone, Butyloctyl Salicylate, Butyl Methoxydibenzoy/methane, Isopropyl Palmitate, Phenethyl Benzoate, Diisostearyl Malate, Ethylhexyl Isononanoate, Capryty Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polymethylsilsesquioxane, Polyethylene, Dimethicone/ Vinyl Dimethicone Crosspolymer, Camellia Japonica Seed Oil, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Candelilla Wax Esters, Artemisia Annua Extract, Copemicia Cerifera (Camauba) Wax, Pinus Sylvestris Leaf Oil, Anthemis Nobilis Flower Oil, Water, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucoside, Butylene Glycol, Glycerin, 1,2-Hexanediol, Betula Platyphylla Japonica Juice, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Viola Mandshurica Flower Extract, Laminaria Japonica Extract, Glyceryl Caprylate, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

Questions Or Comments?

Structured Label Content

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.

Section 50565-1 (50565-1)

Keep out of reach of children

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 51945-4 (51945-4)

BIRCH JUICE MOISTURIZING

UVLOCK SUN STICK

SUN STICK

SPF50+ Broad Spectrum

ROUND LAB

19g 0.67 oz.

Section 60561-8 (60561-8)

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

Purpose

Sunscreen

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

Directions
  • reapply at least every 2 hours.
  • apply liberally 15 minutes before sun exposure.
  • use a water-resistant sunscreen if swimming or sweating.

• 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 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
Other Information (Other information)

protect the product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Homosalate 9.5%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

Diethylhexyl Carbonate, Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diphenylsiloxy Phenyl Trimethicone, Butyloctyl Salicylate, Butyl Methoxydibenzoy/methane, Isopropyl Palmitate, Phenethyl Benzoate, Diisostearyl Malate, Ethylhexyl Isononanoate, Capryty Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polymethylsilsesquioxane, Polyethylene, Dimethicone/ Vinyl Dimethicone Crosspolymer, Camellia Japonica Seed Oil, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Candelilla Wax Esters, Artemisia Annua Extract, Copemicia Cerifera (Camauba) Wax, Pinus Sylvestris Leaf Oil, Anthemis Nobilis Flower Oil, Water, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucoside, Butylene Glycol, Glycerin, 1,2-Hexanediol, Betula Platyphylla Japonica Juice, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Viola Mandshurica Flower Extract, Laminaria Japonica Extract, Glyceryl Caprylate, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

Questions Or Comments? (Questions or comments?)

Advanced Ingredient Data


Raw Label Data

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