Round Lab

Round Lab
SPL v1
SPL
SPL Set ID 26407b83-b417-6450-e063-6294a90ad2b1
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22.28325 g)
Inactive Ingredients
Ethylhexyl Isononanoate Butylene Glycol Dicaprylate/dicaprate Butylene Glycol Glycerin Ascorbic Acid Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate 1,2-hexanediol Hyaluronic Acid Ethylhexyl Methoxycrylene Butyloctyl Salicylate Caprylyl Methicone Methyl Trimethicone Laminaria Japonica Anthemis Nobilis Flower Oil Ascorbyl Palmitate Betula Platyphylla Japonica Juice Glyceryl Caprylate Sodium Hyaluronate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Pinus Sylvestris Leaf Oil Magnesium Sulfate Dipotassium Glycyrrhizate Artemisia Annua Whole Propanediol Water Triethoxycaprylylsilane Disteardimonium Hectorite Polyglycerin-6 Aloe Vera Leaf Glyceryl Glucoside Dioscorea Japonica Root Viola Mandshurica Flower Tocopherol Ulmus Davidiana Root Hydroxyacetophenone Artemisia Annua Leaf Allantoin Polyglyceryl-6 Polyricinoleate

Identifiers & Packaging

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

Zinc Oxide 22%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 22%

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 CUSHION

SUN CUSHION

SPF50+ Broad spectrum

ROUND LAB

15g 0.52 oz.

Section 60561-8

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

Warnings

For external use only.

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 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

Zinc Oxide 22%

Inactive Ingredients

Water, Butyloctyl Salicylate, Caprytyl Methicone, Methyl Trimethicone, Ethylhexyl Isononanoate, Butylene Glycol Dicaprylate/Dicaprate, Pro-panecio, Polyglypery -4 Disostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Methoxycrylene, Alcohol Denat., Methyl Methacrylate Cross-polymer, Polyglycery -6 Polyricinoleate, Triethoxycaprylyisilane, Magnesium Sulfate, 1,2- Hexanediol, Distearimonium Hectorite, Polyglyceryl-6 Polyhydroxystearate, Hydroxy-acetophenone, Artemisia Annua Extract, Polyglyperin-6, Pinus Sylvestris Leaf Oil, Anthemis Nobils Flower Oil, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucaside, Butyiene Glycol Glycerin, Tocopherol, Ascorbyl Palmitate, Betula Platyphylla Japonica Juice, Umus 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?

[email protected]

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 CUSHION

SUN CUSHION

SPF50+ Broad spectrum

ROUND LAB

15g 0.52 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.

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 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

Zinc Oxide 22%

Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Caprytyl Methicone, Methyl Trimethicone, Ethylhexyl Isononanoate, Butylene Glycol Dicaprylate/Dicaprate, Pro-panecio, Polyglypery -4 Disostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Methoxycrylene, Alcohol Denat., Methyl Methacrylate Cross-polymer, Polyglycery -6 Polyricinoleate, Triethoxycaprylyisilane, Magnesium Sulfate, 1,2- Hexanediol, Distearimonium Hectorite, Polyglyceryl-6 Polyhydroxystearate, Hydroxy-acetophenone, Artemisia Annua Extract, Polyglyperin-6, Pinus Sylvestris Leaf Oil, Anthemis Nobils Flower Oil, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucaside, Butyiene Glycol Glycerin, Tocopherol, Ascorbyl Palmitate, Betula Platyphylla Japonica Juice, Umus 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?)

[email protected]

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:21.044574 · Updated: 2026-03-14T23:07:01.452935