FDA.reportPublic FDA data

Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum

Product NDC
84616-002
11-digit product format
846160002
Labeler code
84616
Product ID
84616-002_47d19ffb-d5da-bccf-e063-6394a90a753e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SEORIN COMPANY Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-13
Substance
ZINC OXIDE
Active strength
17 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e7cc417-3c57-c87c-e063-6394a90a670bAvailable on FDA.report

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
84616-002-01Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84616-002ROUND LAB BIRCH JUICE MILD-UP UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM (ZINC OXIDE) CREAM [SEORIN COMPANY CO., LTD.]1Current NDC, 1 package rows20240815_1e7cc417-3c57-c87c-e063-6394a90a670b.zip

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 99 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35Kinfield, Inc.0710db9f-fe91-4b98-a337-5fde33d98a9d2025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.1030c5a4-3067-48e6-a21c-0d327ef434d02025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.612c5730-c3b4-486e-8ce9-8a861f676fa82025-12-30WarningsExact identifier
application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum SunscreenKINFIELD LIPLOCK SUNSCREENKinfield, Inc.477aa1a2-c893-4750-84da-e5afe7ccd45b2025-12-30WarningsExact identifier
application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.cbdfd0ae-514b-4b53-98ad-4270163bd0df2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDECLINIQUE LABORATORIES LLC2397aca5-bf0a-619d-e063-6394a90a7ab92025-12-30WarningsExact identifier
application number: M020
Resource Essentials Sun Protection Mineral SPF 3014% ZINC OXIDESkinresource.md, L.L.C.45b486cf-28ee-6392-e063-6394a90affb02025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47320858-0aea-6ee9-e063-6294a90a9fa92025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light WarmOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47325530-b097-db9a-e063-6294a90a335d2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47328eb4-8ad7-28b5-e063-6294a90a20b12025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732bbec-d9f9-1639-e063-6394a90aff822025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732ecd0-5261-7f11-e063-6394a90a26f32025-12-30WarningsExact identifier
application number: M020
ScalpProtectionSpraySCALP PROTECTION SPRAYNaturich Labsc227ff3a-bbbb-5cc5-e053-2a95a90a8e322025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsExact identifier
application number: M020
SLMDAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONESkin PS Brands1aa36c01-21b5-f06e-e063-6294a90a608f2025-12-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84616-002-018461600020150 mL in 1 TUBE (84616-002-01) 50 ml2024-08-13NoNoCurrent