Lbel Defense Total Sunscreen For Face And Body Spf 50

Lbel Defense Total Sunscreen For Face And Body Spf 50
SPL v4
SPL
SPL Set ID fd0465aa-df1e-ce1c-e053-6294a90a2302
Route
TOPICAL
Published
Effective Date 2023-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Butyloctyl Salicylate Silicon Dioxide Dimethicone Cyclomethicone 6 Potassium Cetyl Phosphate Polymethylsilsesquioxane (4.5 Microns) Alkyl (c12-15) Benzoate Ethylhexyl Methoxycrylene Phenethyl Benzoate Phenoxyethanol Propylene Glycol Vinylpyrrolidone/eicosene Copolymer Cetyl Palmitate Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Physalis Angulata Medium-chain Triglycerides Cetostearyl Alcohol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Xanthan Gum Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Caprylyl Glycol Edetate Disodium Anhydrous Alpha-tocopherol Acetate Trimethylsiloxysilicate (m/q 0.8-1.0) Citric Acid Monohydrate Limonene, (+)- Linalool, (+)- .beta.-citronellol, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-12
Description

Avobenzone 3.00% Homosalate 10.00% Octocrylene 8.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Homosalate 10.00% Octocrylene 8.00%

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.
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.
Do Not Use

on damaged or broken skin.

Package Label

Other Information

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

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octocrylene 8.00%

Company Information

U.S.A. & PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

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.

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.

Structured Label Content

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.
Purpose

Sunscreen

Warnings
  • For external use only.
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.
Do Not Use (Do not use)

on damaged or broken skin.

Package Label

Other Information (Other information)

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

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octocrylene 8.00%

Company Information

U.S.A. & PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

Inactive Ingredients (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.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:21.887383 · Updated: 2026-03-14T23:09:05.302478