Squalane Plus Mineral Spf 45
FDA Label NDC 73517-123

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amyris, Inc. for the product Squalane Plus Mineral Spf 45 (NDC 73517-123). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Titanium Dioxide 4.069%
Zinc Oxide 7%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early signs of aging caused by the sun.

Warnings

  • For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply liberally and evenly to face and neck 15 minutes before sun exposure. Reapply:
    • After 80 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 value of SPF 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m. – 2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses
      • Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Polyglyceryl-3 Sorbityl Linseedate, Cetyl Dimethicone, Dimethicone, Polymethylsilsesquioxane, Glycerin, Styrene/Acrylates Copolymer, Thermus Thermophilus Ferment, Polyhydroxystearic Acid, Synthetic Fluorphlogopite, Sodium Chloride, Hydroxyacetophenone, Tocopheryl Acetate, Saccharide Isomerate, Caramel, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Bisabolol, Benzylidene Dimethoxydimethylindanone, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Zingiber Officinale (Ginger) Root Extract

Other Information

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics.

Questions Or Comments?

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Principal Display Panel - 50 Ml Tube Carton

BIOSSANCE

SQUALANE +
MINERAL SPF 45

BROAD SPECTRUM
UVA/UVB FACIAL
SUNSCREEN LOTION

45

Protects, Primes
& Hydrates Face

50ML/1.6907 FL. OZ.

Principal Display Panel (50 ML Tube Carton)

Principal Display Panel (50 ML Tube Carton)

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