Proactiv ®

Proactiv ®
SPL v4
SPL
SPL Set ID b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1
Route
TOPICAL
Published
Effective Date 2021-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 mg) Octisalate (5 mg) Octocrylene (7 mg)
Inactive Ingredients
Water Isopropyl Lauroyl Sarcosinate Glycerin Dimethicone Diisopropyl Sebacate Poly(methyl Methacrylate; 450000 Mw) Aluminum Starch Octenylsuccinate Sucrose Tristearate Silicon Dioxide Pentylene Glycol Polysorbate 61 Sodium Stearoyl Glutamate Phenoxyethanol Caprylyl Glycol .alpha.-tocopherol Acetate Enoxolone Panthenol Trolamine Allantoin Carboxypolymethylene Potassium Sorbate Zinc Gluconate Xanthan Gum Edetate Disodium Anhydrous Hydroxypalmitoyl Sphinganine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-13
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only.   Do not use ■ on damaged or broken skin. When using this product ■keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if■ rash occurs.

Directions
  • Apply liberally 15 minutes before sun exposure 
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun protection measures. Spending time in the sun increases your risk of 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 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sun glasses.
    • Children under 6 months; Ask a doctor.
Questions?

1-800-950-4695

Active Ingredient

Avobenzone 3%,

Octisalate 5%,

Octocrylene 7%

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
Inactive Ingredients

Water, Isopropyl Lauroyl Sarcosinate, Glycerin, Dimethicone, Diisopropyl Sebacate, Sucrose Tristearate, Polymethyl Methacrylate, Silica, Aluminum Starch Octenylsuccinate, Pentylene Glycol, Polysorbate 61, Sodium Stearoyl Glutamate, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Dimethiconol, Glycyrrhetinic Acid, Xanthan Gum, Potassium Sorbate, Disodium EDTA, Panthenol, Carbomer, Allantoin, Triethanolamine, Zinc Gluconate, Hydroxypalmitoyl Sphinganine

Principal Display Panel 45 Ml Tube Box

proactiv ®

CLEAR SKIN

SPF 30

Broad-spectrum

SPF30

sunscreen

1.5 FL OZ

45 ML

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
Section 42229-5 (42229-5)

Drug Facts

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.

Purpose

Sunscreen

Warnings

For external use only.   Do not use ■ on damaged or broken skin. When using this product ■keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if■ rash occurs.

Directions
  • Apply liberally 15 minutes before sun exposure 
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun protection measures. Spending time in the sun increases your risk of 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 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sun glasses.
    • Children under 6 months; Ask a doctor.
Questions?

1-800-950-4695

Active Ingredient

Avobenzone 3%,

Octisalate 5%,

Octocrylene 7%

Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
Inactive Ingredients

Water, Isopropyl Lauroyl Sarcosinate, Glycerin, Dimethicone, Diisopropyl Sebacate, Sucrose Tristearate, Polymethyl Methacrylate, Silica, Aluminum Starch Octenylsuccinate, Pentylene Glycol, Polysorbate 61, Sodium Stearoyl Glutamate, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Dimethiconol, Glycyrrhetinic Acid, Xanthan Gum, Potassium Sorbate, Disodium EDTA, Panthenol, Carbomer, Allantoin, Triethanolamine, Zinc Gluconate, Hydroxypalmitoyl Sphinganine

Principal Display Panel 45 Ml Tube Box (PRINCIPAL DISPLAY PANEL - 45 ML Tube Box)

proactiv ®

CLEAR SKIN

SPF 30

Broad-spectrum

SPF30

sunscreen

1.5 FL OZ

45 ML

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.885174 · Updated: 2026-03-14T23:12:17.704012