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 78 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4dbfd77-0eec-4d1a-94d6-4daca096d8c72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72569958-cd7d-4d52-add4-2b13706e1b1e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0f5aa600-4168-419b-95d7-569764b5f0b92026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore5ab0cd9-ae7f-4558-b5ab-e0b5826772242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9fa3bb9-12ec-40d8-b433-a96d9d00cc902026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf7b2e348-2c7f-4ff5-8ab0-a3475c9d1f262026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior69924eb8-a8ca-4ea0-b087-c865a6a1313f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5cafac21-fb2d-4d63-a7fe-01bf53b941e82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbfc27e8d-e59b-46f7-aec9-2a96a00a7c1c2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8fd56c86-ef37-4f31-87d1-6283a19c84242026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior91b62ba7-2deb-47e6-b9af-25bb459b4d752026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6eec7554-38ed-48d4-916d-ab3660fbf7032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior939e6d5c-3dd7-4b01-af18-697dc4ba2d992026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7149784b-3548-4643-abf6-58fde237bb982026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior061181d8-5387-4541-a7d7-426cba5997a02026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6ad554a-4795-4149-b066-c53a0989470e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC42c8fd50-73c6-480b-9d7e-31157e5869292026-01-16WarningsExact identifier
application number: M020
HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30ZINC OXIDEKENDO HOLDINGS INC.18fb7472-746f-339a-e063-6294a90a267d2026-01-16WarningsExact 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