FDA Label for Private Label Spf 50 80 Min Water Resistant

View Indications, Usage & Precautions

Private Label Spf 50 80 Min Water Resistant Product Label

The following document was submitted to the FDA by the labeler of this product Swiss-american Cdmo, Llc. 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.

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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.


Uses



Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.


Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN   


Active Ingredients



Homosalate 10.0% Sunscreen
Octisalate 5.0%
Zinc Oxide 16.5% Sunscreen


Directions



Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.


Other Safety Information



Protect this product from excessive heat and direct sun.


Inactive Ingredients



C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water


Questions?



Call toll free 1-866-416-2366


* Please review the disclaimer below.