Lbel Defense Total Sunscreen For Face And Body Spf 50

Lbel Defense Total Sunscreen For Face And Body Spf 50
SPL v1
SPL
SPL Set ID 33db89ac-2653-78f5-e063-6394a90af03d
Route
TOPICAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Octinoxate (30 mg) Octisalate (50 mg) Avobenzone
Inactive Ingredients
Cetearyl Alcohol Butyloctyl Salicylate Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Phenoxyethanol Aluminum Starch Octenylsuccinate Polymethylsilsesquioxane (4.5 Microns) Linalyl Acetate Tetramethyl Acetyloctahydronaphthalenes Alpha-tocopherol Acetate Linalool, (+)- Camphor (natural) Citronellol Ethylhexyl Methoxycrylene Citrus Aurantium Peel Oil Edetate Disodium Water Xanthan Gum Pinene Cyclohexasiloxane Powdered Cellulose C12-15 Alkyl Benzoate Citric Acid Cetyl Palmitate Physalis Angulata Caprylic/capric Triglyceride Potassium Cetyl Phosphate Dimethicone Eicosyl Povidone Hdi/trimethylol Hexyllactone Crosspolymer Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Glycerin Trimethylsiloxysilicate (m/q 0.6-0.8) Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-28

Description

Avobenzone 3.00% Octinoxate 3.00% Octisalate 5.00% Octocrylene 10.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octinoxate 3.00% Octisalate 5.00% Octocrylene 10.00%

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.

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

Avobenzone 3.00%

Octinoxate 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, POTASSIUM CETYL PHOSPHATE, ETHYLHEXYL METHOXYCRYLENE, DIMETHICONE, GLYCERIN, VP/EICOSENE COPOLYMER, ALUMINUM STARCH OCTENYLSUCCINATE, TRIMETHYLSILOXYSILICATE, CELLULOSE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETEARYL ALCOHOL, CETYL PALMITATE, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, CITRIC ACID, LIMONENE, CITRUS AURANTIUM PEEL OIL, LINALOOL, LINALYL ACETATE, TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES, LAVANDULA OIL/EXTRACT, PINENE, CITRONELLOL, CAMPHOR.

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.

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Product Packaging

Active Ingredients

Avobenzone 3.00%

Octinoxate 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Inactive Ingredients (Inactive ingredients)

WATER, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, POTASSIUM CETYL PHOSPHATE, ETHYLHEXYL METHOXYCRYLENE, DIMETHICONE, GLYCERIN, VP/EICOSENE COPOLYMER, ALUMINUM STARCH OCTENYLSUCCINATE, TRIMETHYLSILOXYSILICATE, CELLULOSE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CETEARYL ALCOHOL, CETYL PALMITATE, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, CITRIC ACID, LIMONENE, CITRUS AURANTIUM PEEL OIL, LINALOOL, LINALYL ACETATE, TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES, LAVANDULA OIL/EXTRACT, PINENE, CITRONELLOL, CAMPHOR.

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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