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 205 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid FormulaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEL'Oreal USA Products, Inc.cd69df67-5231-4a75-a9fb-a8669806a8922025-07-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCfea50c84-0567-8547-e053-6394a90aafb72025-07-07WarningsExact identifier
application number: M020
24K Skin Tone Moisturizer SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.b4f37f69-c61d-40c6-86cc-95d041b4d1b52025-07-07WarningsExact identifier
application number: M020
Vine Vera Resveratrol Cabernet Replenishing MoistureOCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.c48a7346-3971-4946-b527-a5549a98e2462025-07-07WarningsExact identifier
application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.1f33a93f-ae3f-4024-9d23-26b01eed17642025-07-03WarningsExact identifier
application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For AthletesAVOBENZONE, OCTISALATE, OCTOCRYLENEDUGOUT ESSENTIALS LLC3b7cddb5-00d2-4998-8eec-5e5a7c5a60972025-07-03WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC09ccb37b-78ee-b510-e063-6294a90a48d52025-07-01WarningsExact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEPort Jervis Laboratories, Inc.4b442fdf-a9cf-7e5a-e063-6394a90a9e1e2025-07-01WarningsExact identifier
application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESincerely Yours Inc.4c9dfa22-70f7-83f6-e063-6394a90aa8c52025-07-01WarningsExact identifier
application number: M020
Nova Bright Skin SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.1c201147-7a54-41b5-bdf0-394e3d7efc0c2025-07-01WarningsExact identifier
application number: M020
Introstem Vitiscell Facial ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.65c28ed6-649d-41d9-b214-aab6ccb02dd52025-07-01WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d049b4-557f-724a-e063-6394a90a19b32025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.2f74965f-3c84-0590-e063-6294a90af2672025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d0d165-e981-284a-e063-6294a90acace2025-06-30WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKINAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inca3dc6195-3011-4e7f-b1b0-0c815b11ba8d2025-06-30WarningsExact identifier
application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE AND OCTISALATELOreal USA Products Inc5712df74-5201-474b-bbfd-703f3117bd9c2025-06-30WarningsExact identifier
application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38bff6d0-5690-3ee5-e063-6294a90a9faa2025-06-29WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact 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