Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion

Manufacturer
SEORIN COMPANY Co., Ltd. | COSMAX, INC.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:39

Label at a glance#

ProductRound Lab Birch Juice Moisturizing UVLOCK Sun Cushion
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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

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 f...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

OTHER SAFETY INFORMATION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

protect the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

cs@roundlab.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIRCH JUICE MOISTURIZING

UVLOCK SUN CUSHION

SUN CUSHION

SPF50+ Broad spectrum

ROUND LAB

15g 0.52 oz.

SPSP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84616-004-01Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion15 g in 1 CONTAINERSPONGE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84616-004ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUN CUSHION (ZINC OXIDE) SPONGE [SEORIN COMPANY CO., LTD.]1Current NDC, 1 package rows20250116_26407b83-b417-6450-e063-6294a90ad2b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84616-00484616-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Round Lab Birch Juice Moisturizing UVLOCK Sun CushionZINC OXIDESEORIN COMPANY Co., Ltd.26407b83-b417-6450-e063-6294a90ad2b12024-11-06WarningsExact identifier
ndc (package): 84616-004-01
ndc (product): 84616-004
ndc11 (package): 84616000401
spl id: 26407b83-b418-6450-e063-6294a90ad2b1
spl set id: 26407b83-b417-6450-e063-6294a90ad2b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.