Drug labels

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 Octinoxate, Titanium Dioxide, Homosala…

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Set ID
1d9cc3ae-9a95-459b-ad05-df1e877d25fa
ID
3130898e-5409-adba-e063-6294a90a7cf3
Effective time
20250325
Version
3
SPL product data elements

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide WATER DICAPRYLYL CARBONATE PROPYLHEPTYL CAPRYLATE GLYCERYL MONOSTEARATE POTASSIUM CETYL PHOSPHATE ALCOHOL CYCLOMETHICONE 6 GLYCERIN SORBITAN MONOSTEARATE BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE SILICON DIOXIDE POLYETHYLENE GLYCOL 400 CETEARETH-12 POLYOXYL 20 CETOSTEARYL ETHER PROPYLENE GLYCOL PHENOXYETHANOL METHYLPARABEN AMBROSIA PERUVIANA LEAF CETOSTEARYL ALCOHOL CETYL PALMITATE XANTHAN GUM CAPRYLYL GLYCOL PROPYLPARABEN CHLORPHENESIN BUTYLENE GLYCOL SUNFLOWER SEED MICA PPG-1-PEG-9 LAURYL GLYCOL ETHER TRIETHOXYCAPRYLYLSILANE CYCLOMETHICONE 5 HEDERA HELIX LEAF FYTIC ACID OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE ZINC OXIDE ZINC OXIDE

SPL unclassified section
Drug Facts, US: Dist. by Ventura Int Ltd. DBA Belcorp USA, San Francisco, CA 94111.
Active ingredient

Active Ingredients Purpose Homosalate (5.00%) Sunscreen Octinoxate (7.00%) Sunscreen Octisalate (5.00%) Sunscreen Oxybenzone (4.00%) Sunscreen Titanium dioxide (6.24%) Sunscreen Zinc oxide (3.92%) Sunscreen

Active ingredient table

<table width="50%"><col width="70%" align="left" valign="top"/><col width="30%" align="right" valign="top"/><thead><tr><th><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></th><th><content styleCode="bold"><content styleCode="italics">Purpose</content></content></th></tr></thead><tbody><tr><td>Homosalate (5.00%)</td><td>Sunscreen</td></tr><tr><td>Octinoxate (7.00%)</td><td>Sunscreen</td></tr><tr><td>Octisalate (5.00%)</td><td>Sunscreen</td></tr><tr><td>Oxybenzone (4.00%)</td><td>Sunscreen</td></tr><tr><td>Titanium dioxide (6.24%)</td><td>Sunscreen</td></tr><tr><td>Zinc oxide (3.92%)</td><td>Sunscreen</td></tr></tbody></table>

Purpose

Active Ingredients Purpose Homosalate (5.00%) Sunscreen Octinoxate (7.00%) Sunscreen Octisalate (5.00%) Sunscreen Oxybenzone (4.00%) Sunscreen Titanium dioxide (6.24%) Sunscreen Zinc oxide (3.92%) Sunscreen

Purpose table

<table width="50%"><col width="70%" align="left" valign="top"/><col width="30%" align="right" valign="top"/><thead><tr><th><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></th><th><content styleCode="bold"><content styleCode="italics">Purpose</content></content></th></tr></thead><tbody><tr><td>Homosalate (5.00%)</td><td>Sunscreen</td></tr><tr><td>Octinoxate (7.00%)</td><td>Sunscreen</td></tr><tr><td>Octisalate (5.00%)</td><td>Sunscreen</td></tr><tr><td>Oxybenzone (4.00%)</td><td>Sunscreen</td></tr><tr><td>Titanium dioxide (6.24%)</td><td>Sunscreen</td></tr><tr><td>Zinc oxide (3.92%)</td><td>Sunscreen</td></tr></tbody></table>

Indications and usage
Uses Helps prevent sunburn.
Warnings

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.

Do not use
Do not use on damaged or broken skin.
When using
When using this product keep out of eyes. Rinse with water to remove.
Stop use
Stop use and ask a doctor if rash occurs.
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

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.

Storage and handling
Other information Protect the product in this container from excessive heat and direct sun.
Inactive ingredient

Inactive ingredients Water, dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis-ethylhexyl 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, propylparaben, chlorphenesin, butylene glycol, helianthus annuus (sunflower) seed extract, mica, ppg-1-peg-9 lauryl glycol ether, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate.

Package label principal display panel

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box L'BEL DÉFENSE 365 oil-free daily protective facial lotion SPF 50 SPF 50 30 ml e (1 fl.oz.) PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.