FDA Label for Broad Spectrum Spf 50 Mineral Sunscreen

View Indications, Usage & Precautions

Broad Spectrum Spf 50 Mineral Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Aruba Aloe Balm Nv. 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.

Active Ingredients



Titanium Dioxide 10%
Zinc Oxide 10%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings



For external use only


Do Not Use



  • on damaged or broken skin

When Using This Product



  • keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If



rash occurs


Keep Out Of Reach Of Children.



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


Directions



  • apply generously 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 SPF value of 15 or higher andd 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

Other Information



  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients



Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated
Hydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Caprylic/Capric Triglyceride, Phenoxyethanol, Caprylyl
Glycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25
Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.


Package Labeling:




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