BLUEVADO SUNFIX- zinc oxide, titanium dioxide lotion

Bluevado Sunfix by

Drug Labeling and Warnings

Bluevado Sunfix by is a Otc medication manufactured, distributed, or labeled by Magic Blue, LLC, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 15%
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 physicianif 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:
  • 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:

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

Inactive Ingredients:

Ascorbyl Palmitate, Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Cetyl Alcohol,Citric Acid,Coco-Caprylate,Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Isostearate,Glyceryl Stearate, Heptyl Undecylenate, Jojoba Esters, Methylene Blue, Oryza Sativa (Rice) Bran Oil, PEG-100 Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60,Pongamia Pinnata Seed Extract, Sorbitan Laurate, Water (Aqua), Xanthan Gum.

Package/Label Principal Display Panel

Bluelene®

Bluevado™
SunFix

Protects, Repairs & Moisturizes
SPF 30

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

Label

INGREDIENTS AND APPEARANCE

BLUEVADO SUNFIX 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77358-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID (UNII: 2968PHW8QP)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
BUTYROSPERMUM PARKII (SHEA) OIL (UNII: O88E196QRF)
SORBITAN LAURATE (UNII: 6W9PS8B71J)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
C13-15 ALKANE (UNII: 114P5I43UJ)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLENE BLUE (UNII: T42P99266K)
RICE BRAN OIL (UNII: LZO6K1506A)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77358-202-03	90 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/31/2025

Labeler - Magic Blue, LLC (114903371)

Registrant - Fragrance Manufacturing, Inc. (793406000)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	manufacture(77358-202)