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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only.

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

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, 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.

Description

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

Do Not Use

on damaged or broken skin.

Product Packaging

Active Ingredients

Avobenzone 3.00%

Octinoxate 3.00%

Octisalate 5.00%

Octocrylene 10.00%

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

Warnings

For external use only.

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

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

Do Not Use (Do not use)

on damaged or broken skin.

Product Packaging

Active Ingredients

Avobenzone 3.00%

Octinoxate 3.00%

Octisalate 5.00%

Octocrylene 10.00%

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:01.225855 · Updated: 2026-03-14T23:08:27.251685