Bluevado Sunfix Sunscreen

Bluevado Sunfix Sunscreen
SPL v3
SPL
SPL Set ID 2e5315bf-39f4-401c-8207-18ef6a97e024
Route
TOPICAL
Published
Effective Date 2021-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.2 g) Titanium Dioxide (2.8 g)
Inactive Ingredients
Argan Oil Ascorbyl Palmitate Levomenol Shea Butter C13-15 Alkane Medium-chain Triglycerides Cetostearyl Alcohol Cetyl Alcohol Bergamot Oil Citrus Maxima Fruit Rind Oil Coconut Oil Glycerin Glyceryl Monostearate Heptyl Undecylenate Lavender Oil Methylene Blue Rice Bran Oil Peg-100 Stearate Geranium Oil, Algerian Type Phenoxyethanol Polysorbate 60 Sorbitan Monolaurate .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-01
Description

Zinc Oxide 8.2% Titanium Dioxide 2.8%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 8.2% Titanium Dioxide 2.8%

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 useon damaged or broken skin.
  • When using thus productkeep 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 8.2%

Titanium Dioxide 2.8%

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.

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 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

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 useon damaged or broken skin.
  • When using thus productkeep 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 8.2%

Titanium Dioxide 2.8%

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.

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 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

Label

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:10.829094 · Updated: 2026-03-14T23:12:20.443473