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 164 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
application number: M020
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15AVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLCe36efd74-11c2-4850-9529-1c88b7364a332025-11-12WarningsExact identifier
application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80minAVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLC22a40d93-ca67-4b7d-a95c-22f52cd6d2972025-11-12WarningsExact identifier
application number: M020
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
application number: M020
Dr Lift SPF 50 Mineral Sunscreen StickZINC OXIDESpa de Soleil436fdf4f-11db-7c5b-e063-6294a90a87312025-11-12WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc3676aa91-c90d-4a7a-b02e-d5b35304a04d2025-11-12WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDdf3bd18d-63b4-460f-bf1c-115ad35edd962025-11-11WarningsExact identifier
application number: M020
Zinka Clear Zinc Oxide SunscreenOCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONEZinka, Inc.7b097f5e-8127-49e6-8a77-4ee1fded5ff12025-11-11WarningsExact identifier
application number: M020
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF15HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC1a1c17c4-4912-4573-9f59-cbd14a014cb42025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF30HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC14f65b3d-90bf-4689-aa6e-879e06153db92025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF50HOMOSALATE, ZINC OXIDE, OCTOCRYLENEQS Key West Aloe, LLCb4fc7a51-a163-4057-8790-f2111668ec672025-11-11WarningsExact identifier
application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEPILLOWTALKDERM LLC30e10a62-8430-649b-e063-6394a90a97eb2025-11-11WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
application number: M020
Tinted Moisturizer SPF 46 Universal TintZINC OXIDE, OCTINOXATEDrmtlgy, LLC5304b568-f891-4094-9182-363ae7bcfbe42025-11-11WarningsExact identifier
application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30SUNSCREENSimply Active Cosmetics323661a6-3602-1ce2-e063-6394a90a8e912025-11-10WarningsExact identifier
application number: M020
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 gZINC OXIDEAspen Glow Cosmetics, LLC142eda44-76e1-7960-e063-6394a90a9ad62025-11-10WarningsExact identifier
application number: M020
TriLipiderm Broad Spectrum SPF 30BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENETriLipid Research Institute, LLC617fc696-c2a1-4855-bafb-0454e64971012025-11-10WarningsExact identifier
application number: M020
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact 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