3 Lab Ww Day Spf 40

3 Lab Ww Day Spf 40
SPL v1
SPL
SPL Set ID 2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e
Route
TOPICAL
Published
Effective Date 2016-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 mg) Octisalate (5 mg) Avobenzone (3 mg) Octocrylene (2.6 mg)
Inactive Ingredients
Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Sodium Phosphate Squalane Olive Oil Glycerin Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Peg-12 Dimethicone/ppg-20 Crosspolymer Orange Oil Water Silicon Dioxide Lavandin Oil Butyloctyl Salicylate Caprylyl Trisiloxane Polymethylsilsesquioxane (11 Microns) Ethylhexyl Palmitate Dimethyl Isosorbide .alpha.-tocopherol Acetate Shea Butter Ceramide 3 Edetate Disodium Erythropoietin Gold Wine Grape Bergamot Oil Malus Domestica Whole Diacetyl Boldine Phenoxyethanol Lecithin, Soybean Sesame Oil Isododecane Medium-chain Triglycerides Azadirachta Indica Bark Xanthan Gum Moringa Oleifera Seed Oil Isomalt Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-05-27
Description

Active Ingredients Homosalate 10% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

Medication Information

Description

Active Ingredients Homosalate 10% Octisalate 5% Avobenzone 3.0% Octocrylene 2.6%

Uses

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
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctorif rash occurs.

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove

Section 50570-1

Do not useon damaged or broken skin.

Section 51727-6

Inactive Ingredients

Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

Warnings

Warnings

For external use only.

Directions

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Apply to all skin exposed to the sun
Other Information

Other information

Protect this product from excessive heat and direct sun

Outer Packaging Label

Bottle Packaging Label

Structured Label Content

Uses (USES)

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
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctorif rash occurs.

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not useon damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients

Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

Warnings (WARNINGS)

Warnings

For external use only.

Directions (DIRECTIONS)

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Apply to all skin exposed to the sun
Other Information (OTHER INFORMATION)

Other information

Protect this product from excessive heat and direct sun

Outer Packaging Label

Bottle Packaging Label

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:04.348105 · Updated: 2026-03-14T23:06:23.767952