FDA.reportPublic FDA data

Calming Days Vegan Sunscreen

Product NDC
85940-307
11-digit product format
859400307
Labeler code
85940
Product ID
85940-307_47173090-5fff-c258-e063-6294a90a9070
Type
HUMAN OTC DRUG
Nonproprietary name
,Octyl Triazone (ethylhexyl triazone), Bisoctrizole, Diethylhexyl Butamido Triazone, Diethylamino Hydroxybenzoyl Hexyl Benzoate
Dosage form
GEL
Route
TOPICAL
Labeler
MERCYCO Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Substance
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; BISOCTRIZOLE; ISCOTRIZINOL; ETHYLHEXYL TRIAZONE
Active strength
3; 2; 1.2; 2.4 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Calming Days Vegan Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE3 g/100mL
BISOCTRIZOLE2 g/100mL
ISCOTRIZINOL1.2 g/100mL
ETHYLHEXYL TRIAZONE2.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ANQ870JD20Internal UNII lookup
8NT850T0YSInternal UNII lookup
2UTZ0QC864Internal UNII lookup
XQN8R9SAK4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38898014-eefe-73ec-e063-6394a90a3738Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85940-307-01Calming Days Vegan Sunscreen50 mL in 1 TUBEGEL502

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 29 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUMAVOBENZONE, HOMOSALATE, AND OCTISALATEInnisfree Corporation524264b8-d360-1d7b-e063-6394a90ab1152026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI)ZINC OXIDEIlia, Inc.b595bcc6-a1ab-25c9-e053-2995a90a87aa2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT)ZINC OXIDEIlia, Inc.b97f7fe9-c070-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE)ZINC OXIDEIlia, Inc.b959e3c3-ca92-ee41-e053-2a95a90a60642026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17 MIHO)ZINC OXIDEIlia, Inc.b595f875-b774-f847-e053-2995a90a28862026-05-21WarningsExact identifier
application number: M020
LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110COCTINOXATE, ZINC OXIDEBEL STAR S.A.526a8e50-b1de-47e5-e063-6394a90a3a292026-05-21WarningsExact identifier
application number: M020
Live Tinted Hueguard Skin TintZINC OXIDELive Tinted0ff39ab1-e8d3-cad9-e063-6394a90af0eb2026-05-21WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Quartz 001ZINC OXIDESunsolve MD Inc26a54f00-d84d-8fe3-e063-6394a90a03e82026-05-21WarningsExact identifier
application number: M020
Inde WildZINC OXIDEInde Wild01529c59-8806-6423-e063-6294a90a49e32026-05-21WarningsExact identifier
application number: M020
CARDON SPF and MOISTURIZERAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc52122434-6e6f-39fc-e063-6394a90a1fd02026-05-21WarningsExact identifier
application number: M020
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45OCTINOXATE AND ZINC OXIDEMerz North America, Inc62c822d9-c8ed-4b95-8d88-806295f5a9362026-05-20WarningsExact identifier
application number: M020
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
application number: M020
Stream2Sea SPF 50ZINC OXIDEStream2Sea5243f110-fe5b-946a-e063-6394a90add7e2026-05-20WarningsExact identifier
application number: M020
SP-FB0D-L0TNBarrierProtectionMineralSunscreenBARRIER PROTECTION MINERAL SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)50786950-1c31-e467-e063-6394a90a6fc82026-05-20WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
application number: M020
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
application number: M020
Evereden Cooling Mineral Sunstick SPF 30ZINC OXIDEEden Brands Inc.4af9e668-0d88-74ad-e063-6394a90a52432026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522addd5-9701-3234-e063-6294a90aaa9d2026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522b4aca-fe5b-dfe2-e063-6394a90ae5782026-05-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85940-307-018594003070150 mL in 1 TUBE (85940-307-01) 50 ml2025-07-01YesNoCurrent