FDA.reportPublic FDA data

SOME BY MI TRUECICA AQUA CALMING SUNSCREEN

Product NDC
74472-501
11-digit product format
744720501
Labeler code
74472
Product ID
74472-501_4d42d5aa-d12f-1086-e063-6294a90a12df
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
PERENNEBELL Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-01
Substance
OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength
2.4; 3.65; 1.5; 4.35 g/50mL; g/50mL; g/50mL; g/50mL
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
SOME BY MI TRUECICA AQUA CALMING SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE2.4 g/50mL
HOMOSALATE3.65 g/50mL
AVOBENZONE1.5 g/50mL
OCTOCRYLENE4.35 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
4d42d5aa-d12e-1086-e063-6294a90a12dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74472-501-01SOME BY MI TRUECICA AQUA CALMING SUNSCREEN50 mL in 1 TUBECREAM501
74472-501-02SOME BY MI TRUECICA AQUA CALMING SUNSCREEN1 in 1 BOXCREAM11

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 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
application number: M020
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
Florida Glow SPF 50AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.dcb43ee0-5ab0-495a-8e68-90cab881337d2025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.20538bc0-10c3-492c-952a-6797e46003f22025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 15AVOBENZONE,OCTOCRYLENE,OCTISALATESoutheast Holdings Corp.56af704a-bda9-49ed-a177-a8480d90458b2025-11-12WarningsExact identifier
application number: M020
Florida Glow face shield SPF 55HOMOSALATE, OCTOCRYLENE, ZINC OXIDESoutheast Holdings Corp.cea54600-5308-4b9f-98ca-fef0b26d79c12025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30ZINC OXIDESoutheast Holdings Corp.4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb2025-11-12WarningsExact 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
ZEUSZINC OXIDENEWPORT APOTHECARY, INC5354c383-08f0-4b89-b36a-96a35f47be3c2025-11-12WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74472-501-017447205010150 mL in 1 TUBE50 mlHistorical
74472-501-02744720501021 TUBE in 1 BOX (74472-501-02) / 50 mL in 1 TUBE (74472-501-01) 1 tube2026-04-01NoNoCurrent