Tinted Sunscreen Spf 30 2-golden Cream
FDA Label NDC 66097-008
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 Spf 30 2-golden (NDC 66097-008). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium dioxide 14.74%
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 cancer 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, synthetic fluorphlogopite, hydrogenated lecithin, dimethicone, disodium edta, glyceryl caprylate, ethylhexylglycerin, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.
Package Labeling:
Outer1 (Outer1)
Inner1 (Inner1)
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