Lbel Defense Total Sunscreen For Face And Body Spf 50 Emulsion
FDA Label NDC 14141-331

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bel Star Sa for the product Lbel Defense Total Sunscreen For Face And Body Spf 50 (NDC 14141-331). 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, do not use, when using this product, stop use and ask a doctor if, 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

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Company Information

→ Package Label

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octocrylene 8.00%

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

Directions

Apply liberally and evenly 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, FRAGRANCE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, CITRIC ACID, LIMONENE, LINALOOL, CITRONELLOL.