FDA Label for Zinc Five-o Spf-50

View Indications, Usage & Precautions

Zinc Five-o Spf-50 Product Label

The following document was submitted to the FDA by the labeler of this product Astivita Limited. 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 Ingredient



ZINC OXIDE 25%


Purpose



SUNSCREEN


Uses



  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased 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 doctor if rash occurs.


Directions:



Apply liberally and evenly 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 value 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-sleeved shirts, pants, hats, and sunglasses
•Children under 6 months of age: ask a doctor.


Other Information



Store at temperatures below 90°F.


Inactive Ingredients



Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA


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