ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM

Product NDC: 84616-007
11-digit product format: 846160007
Labeler code: 84616
Product ID: 84616-007_4fea1efd-c18a-817f-e063-6294a90a8afb
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate
Dosage form: CREAM
Route: TOPICAL
Labeler: SEORIN COMPANY Co., Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-18
Substance: HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength: 13.5; 4.5; 2.7 g/100mL; g/100mL; 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 MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	13.5 g/100mL
OCTISALATE	4.5 g/100mL
AVOBENZONE	2.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
228dcd68-aaba-0451-e063-6394a90a8ad0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84616-007-01	ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM	50 mL in 1 TUBE	CREAM	50	5
84616-007-02	ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM	10 mL in 1 TUBE	CREAM	10	5
84616-007-03	ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM	2 in 1 BOX	CREAM	2	5
84616-007-04	ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM	60 mL in 1 TUBE	CREAM	60	5
84616-007-05	ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM	30 mL in 1 TUBE	CREAM	30	5

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 154 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Super Leaves Lip Balm SPF15 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff1fc0-9ac5-2c9a-e063-6294a90a4632	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Coconut	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ff5675-fd8d-b665-e063-6294a90a1e0b	2025-12-02	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Pineapple	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44ffb35b-80f4-7ddb-e063-6394a90a2cbb	2025-12-02	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	44ffd469-0205-846f-e063-6294a90af6b5	2025-12-02	Warnings	Exact identifier application number: M020
COSRX	VITAMIN E VITALIZING SUNSCREEN	COSRX inc.	daf0291e-770c-eaf2-e053-2a95a90a0b67	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Dewy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE	70541	44e0098c-170f-ca51-e063-6294a90aed20	2025-12-01	Warnings	Exact identifier application number: M020
Centellian24 Madeca Derma Shield Vital Sun Essence	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	70541	44e194cd-ea61-71b3-e063-6394a90ac486	2025-12-01	Warnings	Exact identifier application number: M020
Venture Performance Sun Protection Mineral Sunscreen SPF 50	ZINC OXIDE	Venture Performance Inc	630fc5c2-a315-4e26-9bd9-5f8533d75908	2025-12-01	Warnings	Exact identifier application number: M020
EMINENCE Red Currant Protective Moisturizer	OCTINOXATE, ZINC OXIDE	Eminence Organic Skin Care	7eca62af-6f70-44ec-879e-74712163c4e0	2025-12-01	Warnings	Exact identifier application number: M020
CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer	AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE	Charlotte Tilbury Beauty Ltd.	2b215ecb-7c3a-63db-e063-6394a90aa88f	2025-12-01	Warnings	Exact identifier application number: M020
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	LIFE WITHCORPORATION Inc.	44ea9fb4-8e01-6969-e063-6294a90a6a94	2025-12-01	Warnings	Exact identifier application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Rare Beauty Brands Inc.	44ec0db5-4437-e4a3-e063-6294a90a9a00	2025-12-01	Warnings	Exact identifier application number: M020
RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RoC Skincare	2888a198-116b-8441-e063-6394a90a0f95	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Very High Sun Protection sunscreen	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ec619f-ed3b-2fd3-e063-6294a90a858b	2025-12-01	Warnings	Exact identifier application number: M020
Reef safe - Face and Body sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38603298-e8da-e4c7-e063-6394a90aca3b	2025-12-01	Warnings	Exact identifier application number: M020
ReefSafe Baby and Toddlers Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44dd513e-ebaa-0d6a-e063-6394a90a78b7	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Natural Mineral Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc0ae-a977-3adf-e063-6294a90a0898	2025-11-30	Warnings	Exact identifier application number: M020
Safe4Kidz Baby Zinc Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	44ddc4d8-3f3b-5d11-e063-6294a90ae88a	2025-11-30	Warnings	Exact identifier application number: M020
Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S A	b56f5883-be57-e0e5-e053-2a95a90adb0c	2025-11-29	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral sunscreen Sprayer SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44a94a24-e292-41e6-e063-6394a90abe47	2025-11-28	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84616-007-01	84616000701	50 mL in 1 TUBE (84616-007-01)	50 ml	2024-09-18	No	No	Current
84616-007-02	84616000702	10 mL in 1 TUBE (84616-007-02)	10 ml	2024-12-18	No	No	Current
84616-007-03	84616000703	2 TUBE in 1 BOX (84616-007-03) / 60 mL in 1 TUBE (84616-007-04)	2 tube	2024-12-20	No	No	Current
84616-007-04	84616000704	60 mL in 1 TUBE	60 ml				Historical
84616-007-05	84616000705	30 mL in 1 TUBE (84616-007-05)	30 ml	2026-04-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Round Lab Birch Juice Moisturizing UVLOCK Sunscreen SPF50 Broad Spectrum	SEORIN COMPANY Co., Ltd. \| Kolmar Korea Co., Ltd	2026-04-20	HUMAN OTC DRUG LABEL	5