Lbel Uv Defense 365
FDA Label NDC 14783-094

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ventura International Ltd. (san Juan, P.r) for the product Lbel Uv Defense 365 (NDC 14783-094). 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 other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by Ventura International Ltd, San Francisco, CA 94111.

Otc - Purpose

Active IngredientsPurpose
Homosalate (5 %)Sunscreen
Octinoxate (7 %)Sunscreen
Octisalate (5 %)Sunscreen
Oxybenzone (4 %)Sunscreen
Titanium Dioxide (6.24%) Sunscreen
Zinc Oxide (3.88%)Sunscreen

Uses

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection

Warnings

  • For external use only.

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor if rash and irritation develops and lasts.

Otc - 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.

Directions

  • Apply smoothly every morning before sun exposure and as needed.

Other Information

  • High sun protection product.
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
  • Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.

Inactive Ingredients

aqua (water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bisethylhexyl 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, chlorphenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix extract (hedera helix (ivy) leaf/ stem extract), phytic acid, sodium polyacrylate.

Principal Display Panel - 30 Ml Carton

L'BEL

UV DÉFENSE 365

oil-free daily protective
facial lotion SPF 50

UVB SPF 50
UVA PA +++

30 ml e (1 fl. oz.)

Principal Display Panel (30 ml Carton)

Principal Display Panel (30 ml Carton)

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