FDA Label for Sunscreen Broad Spectrum Spf 55 Moisturizing

View Indications, Usage & Precautions

Sunscreen Broad Spectrum Spf 55 Moisturizing Product Label

The following document was submitted to the FDA by the labeler of this product Scarsdale Integrative Family Medicine Pllc. 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.

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DRUG FACTS


Active Ingredients



Octinoxate 7.5%

Zinc Oxide 4.8%


Purpose



Sunscreen


Uses



Help prevent sunburn.


Warnings



For external use only.


Otc - Do Not Use



Do not use on damaged or broken skin.


Otc - When Using



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


Otc - Stop Use



Stop use and ask a doctor if rash or irritation occurs.


Otc - 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.


Directions



Apply liberally and evenly 15 minutes before sun exposure.

For children under 6 months of age: Ask a doctor.

Reapply:

At least 80 minutes after 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-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients



Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.


Other Information



Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.


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