FDA.reportPublic FDA data

Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set

Manufacturer
SEORIN COMPANY Co., Ltd. | Kolmar Korea Co., Ltd
Effective date
2026-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:07

Label at a glance#

ProductRound Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE
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 cause by the sun.

Dosage and administration

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 ch...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%

Homosalate 13.5%

Octisalate 4.5%

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other Informatiom

SPL UNCLASSIFIED SECTION

protect the product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Propanediol, Acrylates Copolymer, Butylene Glycol, Caprylyl Methicone, Polyglyceryl-3 Distearate, Benzotriazolyl Dodecyl P-Cresol, Niacinamide, Diethylhexyl 2,6-Naphthalate, Polymethylsisesquioxane, Glycerin, Calcium Aluminum Borosilicate, 1,2-Hexanediol, Poly C10-30 Alkyl Acrylate, Pentylene Glycol, Cetearyl Aloohol, Tromethamine, Methy propanediol, Glyceryl Stearate Citrate, Betula Platyphylla Japonica Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Ethylhexylglycerin, Artemisia Annua Extract, Anthemis Nobilis Flower Oil, Sodium Stearoyl Glutamate, Glyceryl Polymethacrylate, Triethoxycaprylylsilane, Pinus Sylvestris Leaf Oil, Sparassis Crispa Extract, Polyether-1, Allantoin, Di-propylene Glycol, Glyceryl Glucoside, Biosaccharide Gum-1, Tocopherol, Portulaca Oleracea Extract, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

ROUND LAB x OUWR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROUND LAB x OUWR

BIRCH JUICE MOISTURIZING CREAM UVLOCK GIFT SET

SCRUNCHIE INCLUDED

BIRCH JUICE MOISTURIZING UVLOCK

SUNSCREEN
SPF 50 Broad spectrum

50 mL / 1.69 fl.oz.

BIRCH JUICE MOISTURIZING CLEANSER

20mL / 0.67 fl.oz.

SPSP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84616-011-01Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set1 in 1 CARTONKIT12
84616-012-01Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set50 mL in 1 TUBECREAM50 mL in 704.5 g in 100mL2

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84616-01184616-011-01
84616-01284616-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
AVOBENZONEG63QQF2NOXACTIB
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
TROMETHAMINE023C2WHX2VIACT
PURSLANEM6S840WXG5IACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
BETULA PLATYPHYLLA VAR. JAPONICA RESIN1B33PG6N4KIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
TOCOPHEROLR0ZB2556P8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
HYALURONIC ACIDS270N0TRQYIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
ARTEMISIA ANNUA LEAFE4M09UY5BLIACT
BENZOTRIAZOLYL DODECYL P-CRESOL298PX4M11XIACT
SPARASSIS CRISPA FRUITING BODYBOO3RTP9PXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL POLYMETHACRYLATE (300000 MPA.S)2B25A5KAD6IACT
PROPANEDIOL5965N8W85TIACT
OCTISALATE4X49Y0596WACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
HOMOSALATEV06SV4M95SACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERYL GLUCOSIDE3297VXM8Z6IACT
POLYETHER-1 (2800 MPA.S)6QR7NJP3G8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-04-20monthly-update2026-06-03 18:00:42

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 x OUWR Birch Juice Moisturizing UVLOCK Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4feb1010-469f-7e6e-e063-6394a90a9a9e2026-05-14WarningsExact identifier
ndc (package): 84616-012-01
ndc (package): 84616-011-01
ndc (product): 84616-011
ndc11 (package): 84616001101
ndc11 (package): 84616001201
spl id: 51ce5f29-5a7d-d208-e063-6294a90ad7a9
spl set id: 4feb1010-469f-7e6e-e063-6394a90a9a9e

Reported adverse events (FAERS/openFDA)#

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