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 138 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Moisturizing Glow Sunscreen CreamZINC OXIDEShelley Bennett Skincare326e49b8-e21c-0df0-e063-6394a90a2ebc2025-12-10Exact identifier
application number: M020
Daily Moisturizing Glow Sunscreen CreamZINC OXIDESHELLEY BENNET SKINCARE325df1f8-1678-c07c-e063-6294a90a96fb2025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bafa0b-d253-c263-e063-6394a90ad1e42025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35ba578f-a842-7eec-e063-6394a90a11652025-12-10Exact identifier
application number: M020
Tinted Mineral Sunscreen Zinc OxideZINC OXIDEHirschman, Kristina35bb3b36-3886-ea8e-e063-6394a90a52572025-12-10Exact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bc3994-1f72-2bbf-e063-6294a90ac2f12025-12-10Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bccadf-6fc8-abd0-e063-6294a90aaa2e2025-12-10Exact identifier
application number: M020
Mineral Sunscreen Zinc OxideZINC OXIDEHirschman, Kristina35bb9341-355f-4910-e063-6294a90a8c152025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3118c3ed-f0f0-f997-e063-6294a90a53a92025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3117faeb-1792-1b2e-e063-6294a90a92df2025-12-10WarningsExact identifier
application number: M020
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
application number: M020
Morning ReplenishZINC OXIDERestore Skin Therapy, LLC364b26c2-a1bb-9660-e063-6294a90a14d12025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC34288989-35b8-3aa3-e063-6394a90ac2c42025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC3418394b-fede-65ce-e063-6394a90ad5f92025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC341871e5-c170-7560-e063-6394a90a8eee2025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC3428bdbb-1f18-a29b-e063-6294a90addbc2025-12-10Exact 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