Lbel Defense 365 Daily Protective Facial Spf 50
FDA Label NDC 43596-0001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ventura Corporation, Ltd for the product Lbel Defense 365 Daily Protective Facial Spf 50 (NDC 43596-0001). 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 l'bel defense 365 oil-free daily protective facial lotion spf 50, active ingredients, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate (5%)
Octinoxate (7.0%)
Octisalate (5.0%)
Oxybenzone (4.0%)
Titanium Dioxide (6.24%)
Zinc Oxide (3.92%)
Uses
- Helps prevent sunburn.
Warnings
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor.
Other Information
- Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aqua (Water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis0ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, silica, methicone, peg-8, ceteareth-12, ceteareth-20, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, cetearyl alcohol, cetyl palmitate, xanthan gum, caprylyl glycol, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorophenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix leaf/stem extract (hedera helix (ivy) leaf/stem extract), phytic acid, sodium polyacrylate.
Purpose
Package Label.Principal Display Panel
US: Dist. by Ventural Internationa Ltd. DBA Bellcorp USA, San Francisco, CA 94111
P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926 MADE IN FRANCE
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