FDA.reportPublic FDA data

TIBENA ALWAYS REAL SUN BLOCK UV SPF 45

Product NDC
74740-045
11-digit product format
747400045
Labeler code
74740
Product ID
74740-045_2aafbd33-710b-201e-e063-6294a90ab1bb
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Ethylhexyl Salicylate, Homosalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
KONAD CO LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-02
Substance
HOMOSALATE; ETHYLHEXYL SALICYLATE; AVOBENZONE; OCTOCRYLENE
Active strength
5; 2.5; 1.5; 5 g/50g; g/50g; g/50g; g/50g
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
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5 g/50g
ETHYLHEXYL SALICYLATE2.5 g/50g
AVOBENZONE1.5 g/50g
OCTOCRYLENE5 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal 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
2aafbd33-710a-201e-e063-6294a90ab1bbAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74740-045-01TIBENA ALWAYS REAL SUN BLOCK UV SPF 4550 g in 1 TUBECREAM501
74740-045-02TIBENA ALWAYS REAL SUN BLOCK UV SPF 451 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74740-045TIBENA ALWAYS REAL SUN BLOCK UV SPF 45 (AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE) CREAM [KONAD CO LTD]1Current NDC, 2 package rows20250105_2aafbd33-710a-201e-e063-6294a90ab1bb.zip

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 203 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact identifier
application number: M020
Face Reality Power Mineral Sunscreen SPF 50ZINC OXIDEFace Reality,LLC8c502e11-6e97-46d6-8775-1bbafaeb18f82025-07-29WarningsExact identifier
application number: M020
SPF30 unseen sunscreen stick 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3afa3bdb-e924-55c1-e063-6394a90af3522025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b016dcf-fb74-916f-e063-6294a90a683d2025-07-28WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3b01c6a4-2230-c83e-e063-6294a90aa66d2025-07-28WarningsExact identifier
application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b022c84-00a5-ece9-e063-6294a90a09bd2025-07-28WarningsExact identifier
application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b02c3f2-a43a-0d29-e063-6394a90a76b52025-07-28WarningsExact identifier
application number: M020
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
application number: M020
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
application number: M020
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74740-045-017474000450150 g in 1 TUBE50 gHistorical
74740-045-02747400045021 TUBE in 1 BOX (74740-045-02) / 50 g in 1 TUBE (74740-045-01) 1 tube2025-01-02NoNoCurrent