FDA Label for Tinted Sunscreen Cream Spf 30 4-deep Amber

View Indications, Usage & Precautions

Tinted Sunscreen Cream Spf 30 4-deep Amber Product Label

The following document was submitted to the FDA by the labeler of this product C.f.e.b. - Sisley. 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 12.93%

Zinc oxide 10.89%


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


Directions



  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of swimming or sweating.
    • Immediately after towel drying.
    • At least every 2 hours.
    • Children under 6 months of age: ask a doctor.
    • ​Sun Protection Measures.​ Spending time in the sun increases your risk of skin cancern and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 am to 2 pm.
      • Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information



Protect the product in the container from excessive heat or direct sun.


Inactive Ingredients



water, c9- 12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, dimethicone, hydrogenated lecithin, disodium edta, glyceryl caprylate, ethylhexyglycerin, synthetic fluorphlogopite, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.


Package Labeling




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