Bluevado Sunfix Lotion
FDA Label NDC 77358-201

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 77358-201). 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 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:
    • oLimit time in the sun, especially from 10 a.m. – 2 p.m.
    • oWear long sleeves shirts, pants, hats, and sunglasses
    • oChildren 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

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Label

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