Bluevado Sunfix Lotion
FDA Label NDC 77358-202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Magic Blue, Llc for the product Bluevado Sunfix (NDC 77358-202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings:, keep out of reach of children., directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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