FDA.reportPublic FDA data

Round Lab Holiday Heroes Gift Set

Product NDC
84616-017
11-digit product format
846160017
Labeler code
84616
Product ID
84616-017_5a0e0321-3000-7f82-e063-6394a90aa2f0
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
KIT
Labeler
SEORIN COMPANY Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-27
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 Holiday Heroes Gift Set
Listing expiration
2027-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a0d3a85-caff-a90d-e063-6394a90ad045Available on FDA.report

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 108 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avail Facial Sunscreen SPF 25HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEmeis Cosmetics Pty Ltd7be903e4-5f07-35b2-e053-2991aa0a13402025-12-17WarningsExact identifier
application number: M020
Mineral Sheer StickZINC OXIDESupergoop, LLC0beed72e-51df-d15a-e063-6394a90af5592025-12-17WarningsExact identifier
application number: M020
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0NENSULIZOLE, OCTISALATEParfums Christian Dior31141a45-54e2-4463-ab42-4df56d9116502025-12-17WarningsExact identifier
application number: M020
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
application number: M020
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedZINC OXIDEGlow Advanced Skin and Body Care, LLC3635e45b-6978-ac69-e063-6294a90a22ac2025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
application number: M020
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
application number: M020
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
application number: M020
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
application number: M020
tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a1edd-56e1-55f0-e063-6294a90a45a62025-12-17Exact identifier
application number: M020
non-tinted face and body mineral sunscreen SPF40ZINC OXIDELisa Nadler Skin Care and Waxing364a8c8d-df84-e568-e063-6394a90aaff12025-12-17Exact identifier
application number: M020
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
application number: M020
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
application number: M020
ULTRA SILK PROTECTION SUNSCREENZINC OXIDESKINFINITY383ea760-d55e-a32a-e063-6294a90aa3d22025-12-17Exact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f67134c-88e8-8513-e063-6294a90aaf5a2025-12-17WarningsExact identifier
application number: M020
Bella Blu Skin Care Non Tinted SunscreenZINC OXIDEBELLA BLU STUDIOS INC3f66d2ae-00e7-608c-e063-6294a90a49c62025-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84616-017-01846160017011 KIT in 1 CARTON (84616-017-01) * 30 mL in 1 TUBE * 50 mL in 1 TUBE (84616-016-01) * 20 mL in 1 JAR1 kit2026-08-27NoNoCurrent