FDA.reportPublic FDA data

Bluevado Sunfix

Product NDC
77358-202
11-digit product format
773580202
Labeler code
77358
Product ID
77358-202_31f1e961-371a-f70a-e063-6394a90a481e
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
2025-05-31
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
15; 2.8 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
Bluevado Sunfix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 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
31f1e961-3719-f70a-e063-6394a90a481eAvailable 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
77358-202-03Bluevado Sunfix90 mL in 1 TUBELOTION903

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 254 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUMZINC OXIDECOSMAX USA, CORPORATION298707d4-72ed-796f-e063-6294a90aa5cd2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM LIGHTZINC OXIDECOSMAX USA, CORPORATION29871c02-9adf-6266-e063-6394a90a20ab2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM TANZINC OXIDECOSMAX USA, CORPORATION29874029-24bf-b2ce-e063-6394a90acd4d2024-12-18WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.2990e4ff-5bdb-3008-e063-6294a90a94972024-12-18WarningsExact identifier
application number: M020
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29915354-4673-7444-e063-6294a90a0fd12024-12-18WarningsExact identifier
application number: M020
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30ZINC OXIDESaltyface Natural Incf0cc7ce9-81b3-439f-b5ee-96138de54e782024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
application number: M020
Costa Sea Mineral Sunscreen SPF 50ZINC OXIDECOSTA SEA INC841e1b3d-dbbc-4bb0-886a-fb2d077ae7392024-12-18WarningsExact identifier
application number: M020
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
application number: M020
Softlips Vanilla, Watermelon, CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company2235d029-157e-4a30-be90-605e6bc143fd2024-12-17WarningsExact identifier
application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
application number: M020
Softlips Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
application number: M020
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
application number: M020
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
application number: M020
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77358-202-037735802020390 mL in 1 TUBE (77358-202-03) 90 ml2025-05-31NoNoCurrent