Particle For Men Invisible Sunscreen Spf 40

Particle For Men Invisible Sunscreen Spf 40
SPL v1
SPL
SPL Set ID 29fe531e-2ade-170f-e063-6394a90a1396
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 mg) Octisalate (5 mg) Octocrylene (2.6 mg) Avobenzone (3 mg)
Inactive Ingredients
Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Benzoate Peg-12 Dimethicone/ppg-20 Crosspolymer Dimethyl Isosorbide Isomalt Water Ethylhexyl Palmitate .alpha.-tocopherol Acetate Caprylyl Trisiloxane Polymethylsilsesquioxane (4.5 Microns) Tocopherol Isododecane Butyloctyl Salicylate Medium-chain Triglycerides Lecithin, Sunflower Silicon Dioxide Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Sesame Seed Vitis Vinifera Fruit Rind

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-28

Description

Active ingredients Homosalate 10% Octisalate 5% Avobenzone 3% Octocrylene 2.6%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • Helps prevent sunburn
  • If used as directed with other Sun Protection Measures (see Directions) decrease the risk of skin cancer and early skin aging damaged by the sun
Description

Active ingredients Homosalate 10% Octisalate 5% Avobenzone 3% Octocrylene 2.6%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifrash occurs

Section 50567-7

When you use 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:

Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

Section 51945-4

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Octocrylene 2.6%

Directions

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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
  • Children under 6 months of age: Ask a doctor

Other Information

Other information

  • Protect this product from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps prevent sunburn
  • If used as directed with other Sun Protection Measures (see Directions) decrease the risk of skin cancer and early skin aging damaged by the sun
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifrash occurs

Section 50567-7 (50567-7)

When you use 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:

Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Octocrylene 2.6%

Directions

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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
  • Children under 6 months of age: Ask a doctor

Other Information (Other information)

Other information

  • Protect this product from excessive heat and direct sun

Advanced Ingredient Data


Raw Label Data

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