FDA Label for Squalane Plus Mineral Spf 45

View Indications, Usage & Precautions

Squalane Plus Mineral Spf 45 Product Label

The following document was submitted to the FDA by the labeler of this product Amyris, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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