FDA.reportPublic FDA data

SEKKISEI HERBAL UV DEFENSE gel

Product NDC
66820-0400
11-digit product format
668200400
Labeler code
66820
Product ID
66820-0400_42ff269f-2905-3c40-e063-6394a90a323d
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
KOS� America, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 95; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL
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
SEKKISEI HERBAL UV DEFENSE gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE95 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE26 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb0faa3a-68f8-49c5-8c28-3338b1b27cd8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66820-0400-1SEKKISEI HERBAL UV DEFENSE gel30 mL in 1 TUBEGEL303
66820-0400-1SEKKISEI HERBAL UV DEFENSE gel1 in 1 CARTONGEL13
66820-0400-2SEKKISEI HERBAL UV DEFENSE gel2 mL in 1 PACKETGEL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66820-0400SEKKISEI HERBAL UV DEFENSE GEL (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) GEL [KOSE AMERICA, INC.]2Current NDC, 3 package rows20240316_cb0faa3a-68f8-49c5-8c28-3338b1b27cd8.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 43 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact identifier
application number: M020
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66820-0400-1668200400011 TUBE in 1 CARTON (66820-0400-1) / 30 mL in 1 TUBE1 tube2024-03-01NoNoCurrent
66820-0400-2668200400022 mL in 1 PACKET (66820-0400-2) 2 ml2026-05-08NoNoCurrent