Tinted Sunscreen Cream Spf 30 4-deep Amber Cream
FDA Label NDC 66097-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.f.e.b. - Sisley for the product Tinted Sunscreen Cream Spf 30 4-deep Amber (NDC 66097-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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