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 198 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
application number: M020
Sun Bum Face 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1ed89c-6d50-6400-e063-6294a90a14332025-08-11WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9ea4d-3073-c126-e063-6394a90a7c6e2025-08-10WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETId1c5b7a5-73f9-4df6-9469-ce42e4f33ae82025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96efeb92-a276-4ac9-b30a-11b4fa3672632025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER PEACH SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIedeb2ee1-cc84-4254-80c1-6410cd77c4222025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER STRAWBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI7abe936b-a4d5-457c-9cdd-761b201bb0462025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER BLUEBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIe4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI8be1c27c-7988-47c4-b613-3bc86f53981e2025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRYAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa3c8d778-ce9c-46eb-a0c3-6886eb1d39342025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI6cdb0b61-a9c2-4a78-9752-8e7aedaeef452025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINKAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIf1b6c068-06d2-4a44-8199-7111d1b6a0d62025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER COOKIE SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI0274f5f1-1ee1-48a5-af7a-deb3aa3a34d72025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER ICE MINT SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIa355777b-2cce-48ce-acc6-2aa7f154c4ba2025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER RASPBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI5443202c-4f88-4063-a227-c50abbd480d62025-08-08WarningsExact identifier
application number: M020
SUNSCREEN SPF50ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDEGuangzhou Tinsun Biotechnology Company Limited3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e2025-08-07WarningsExact 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