BLUEVADO SUNFIX- zinc oxide, titanium dioxide lotion 
Magic Blue, LLC

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Bluevado Sunfix Sunscreen

Active Ingredients

Zinc Oxide 8.2%
Titanium Dioxide 2.8%

Purpose

Sunscreen

Uses

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

Warnings:

For external use only
Do not use on damaged or broken skin.
When using thus product keep out of eyes.
Rinse with water to remove.
Stop use and ask a physician if rash occurs.

Keep out of reach of children.

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

Directions:

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:
o
Limit time in the sun, especially from 10 a.m. – 2 p.m.
o
Wear long sleeves shirts, pants, hats, and sunglasses
o
Children under 6 months: Ask a physician.

Other Information:

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

Inactive Ingredients:

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

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

image-01

Label

BLUEVADO SUNFIX 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77358-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.2 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARGAN OIL (UNII: 4V59G5UW9X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEA BUTTER (UNII: K49155WL9Y)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
METHYLENE BLUE (UNII: T42P99266K)  
RICE BRAN OIL (UNII: LZO6K1506A)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77358-201-0390 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2021
Labeler - Magic Blue, LLC (114903371)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(77358-201)

Revised: 1/2024
Document Id: 399a2395-a185-4687-87cb-9122c2104a13
Set id: 2e5315bf-39f4-401c-8207-18ef6a97e024
Version: 2
Effective Time: 20240111
 
Magic Blue, LLC