bluevado sunfix sunscreen

bluevado sunfix sunscreen
SPL v3
SPL
SPL Set ID 31f1e961-3719-f70a-e063-6394a90a481e
Route
topical
Published
Effective Date 2025-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (15 g) titanium dioxide (2.8 g)
Inactive Ingredients
caprylyl glycol citric acid heptyl undecylenate butyrospermum parkii (shea) oil sorbitan laurate jojoba oil, randomized glyceryl stearate cocos nucifera (coconut) oil capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) caprylic/capric triglyceride polyhydroxystearic acid (2300 mw) coco-caprylate glyceryl isostearate pongamia pinnata seed ascorbyl palmitate c13-15 alkane cetyl alcohol glycerin methylene blue rice bran oil water peg-100 stearate phenoxyethanol polysorbate 60 xanthan gum cetearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-31
Purpose

Sunscreen

Description

Zinc Oxide 15% Titanium Dioxide 2.8%

Medication Information

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

Sunscreen

Description

Zinc Oxide 15% Titanium Dioxide 2.8%

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.
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.
Active Ingredients

Zinc Oxide 15%

Titanium Dioxide 2.8%

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.

Keep Out of Reach of Children.

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

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

Structured Label Content

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

Sunscreen

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.
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.
Active Ingredients

Zinc Oxide 15%

Titanium Dioxide 2.8%

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package/label Principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:12.286540 · Updated: 2026-03-14T23:08:50.768383