FDA.reportPublic FDA data

Bluevado Sunfix

Product NDC
77358-201
11-digit product format
773580201
Labeler code
77358
Product ID
77358-201_484a56e3-3673-c351-e063-6294a90aa340
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Magic Blue, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
8.2; 2.8 g/100mL; g/100mL
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
Bluevado Sunfix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE8.2 g/100mL
TITANIUM DIOXIDE2.8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e5315bf-39f4-401c-8207-18ef6a97e024Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77358-201-03Bluevado Sunfix90 mL in 1 TUBELOTION903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77358-201BLUEVADO SUNFIX (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [MAGIC BLUE, LLC]2Current NDC, Legacy NDC, 1 package rows20240113_2e5315bf-39f4-401c-8207-18ef6a97e024.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 188 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunglaze Body Gel Cream Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC3e6658a1-ae6a-9d19-e063-6294a90acae72025-09-09WarningsExact identifier
application number: M020
CLARINS Extra Firming Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins57f07e8a-1043-47e4-9d7b-6e78fdc341192025-09-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC1d3218e6-8687-4a94-8bf7-3a867920cd1c2025-09-08WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC6c578ef8-5648-4428-b9a2-0952f96252532025-09-08WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC16ac7877-8dfd-3d69-e063-6394a90a5a8a2025-09-08WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD388fb3db-29d2-bb29-e063-6394a90a4efb2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ld279693f-2254-4f3c-a121-144f95f9f25d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light MediumZINC OXIDEDolce & Gabbana Beauty S.R.L7f007540-8271-4d85-9d1e-b2b273ca05f82025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L5198d3df-ffa8-45eb-93d1-11e9f3961b922025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N MediumZINC OXIDEDolce & Gabbana Beauty S.R.La82d85c4-c6ef-4083-b67a-2d6b0e8fc10d2025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L4ee6cac6-f649-436c-ada2-e024b86add692025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N MediumZINC OXIDEDolce & Gabbana Beauty S.R.Ledd4e8c3-b47a-4cfe-bf20-e856edb76e212025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W MediumZINC OXIDEDolce & Gabbana Beauty S.R.L457f0a5c-c543-44f8-82d6-1096a8aab9842025-09-08WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N MediumZINC OXIDEDolce & Gabbana Beauty S.R.L1452ffc4-a83f-472f-ae70-9e1002f889452025-09-08WarningsExact identifier
application number: M020
Protect and Hydrate Radiance Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3e4db4f8-cba5-dbfd-e063-6394a90ab0a02025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of SunshineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3e518d8a-f52b-4ae1-e063-6394a90aaa1e2025-09-08WarningsExact identifier
application number: M020
Ocean Potion Suncare 50 Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGNL BRANDS INTERNATIONAL, LLC3c5a624a-8844-b782-e063-6294a90a478c2025-09-08WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77358-201-037735802010390 mL in 1 TUBE (77358-201-03) 90 ml2021-12-010000-00-00NoNoCurrent