FDA.reportPublic FDA data

Bluevado Sunfix

Manufacturer
Magic Blue, LLC | Fragrance Manufacturing, Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:32:27

Label at a glance#

ProductBluevado Sunfix
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn If used with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: after 40 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8.2%
Titanium Dioxide 2.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging.

Warnings:

WARNINGS SECTION

  • For external use only
  • Do not useon damaged or broken skin.
  • When using thus productkeep out of eyes.
    Rinse with water to remove.
  • Stop use and ask a physicianif rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply: after 40 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long sleeves shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a physician.

Other Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. Provides moderate protection against sunburn.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Argania Spinosa (Argan) Kernel Oil, Ascorbyl Palmitate, Bisabolol Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Methylene Blue, Oryza Sativa (Rice) Bran Oil, PEG-100 Stearate, Pelargonium Graveolens (Geranium) Leaf Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Sorbitan Laurate, Tocopheryl Acetate, Water (Aqua), Xanthan Gum.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bluelene®


Bluevado™
SunFix

Protects, Repairs & Moisturizes
SPF 21

SPF DAY CREAM

Revolutionary Anti-aging Technology
Mineral + Methylene Blue
Broad-Spectrum UVA/UVB Coverage

CORAL SAFE

3 fl oz (90 mL)



Manufactured for Mblue Labs,
Bethesda, MD 20817, USA
1-800-988-8068
www.bluelene.com

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Label

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77358-20177358-201-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARGAN OIL4V59G5UW9XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
C13-15 ALKANE114P5I43UJIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
BERGAMOT OIL39W1PKE3JIIACT
CITRUS MAXIMA FRUIT RIND OIL8U3877WD44IACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
LAVENDER OILZBP1YXW0H8IACT
METHYLENE BLUET42P99266KIACT
RICE BRAN OILLZO6K1506AIACT
PEG-100 STEARATEYD01N1999RIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN MONOLAURATE6W9PS8B71JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
ndc (package): 77358-201-03
ndc (product): 77358-201
ndc11 (package): 77358020103
spl id: 484a56e3-3673-c351-e063-6294a90aa340
spl set id: 2e5315bf-39f4-401c-8207-18ef6a97e024

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.