SPL v6
SPL
SPL Set ID 24389324-19db-7eb5-e063-6394a90ad7fb
Route
TOPICAL
Published
Effective Date 2025-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (70 mg) Avobenzone (30 mg) Octisalate (50 mg) Octocrylene (80 mg)
Inactive Ingredients
Dimethicone, Unspecified Caprylyl Trisiloxane Cetostearyl Alcohol Kakadu Plum .alpha.-tocopherol Acetate Citric Acid Monohydrate Caprylhydroxamic Acid Sodium Citrate Pentylene Glycol Lactic Acid Carnauba Wax Water Squalane Ferric Oxide Yellow Silicon Dioxide Glyceryl Caprylate Sorbitan Isostearate Ferrosoferric Oxide Diisopropyl Adipate Alcohol Butylene Glycol Glycerin Isododecane Rice Bran Polysorbate 60 Polyoxyl 20 Cetostearyl Ether Nylon-12 Saccharide Isomerate Edetate Disodium Carnosine Peg-40 Monostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Trolamine Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01
Description

AVOBENZONE 3.0% HOMOSALATE 7.0% OCTISALATE 5.0% OCTOCRYLENE 8.0%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

AVOBENZONE 3.0% HOMOSALATE 7.0% OCTISALATE 5.0% OCTOCRYLENE 8.0%

Use

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

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 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
Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients

Water, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA,

Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).

For External Use Only

Principal Display Panel

Supreme Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

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

Use (USE)

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 (PURPOSE)

SUNSCREEN

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 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
Do Not Use (Do not use)

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sun

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE 3.0%

HOMOSALATE 7.0%

OCTISALATE 5.0%

OCTOCRYLENE 8.0%

Inactive Ingredients

Water, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA,

Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).

For External Use Only (For external use only)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Supreme Screen Broad Spectrum SPF 50

1.7 FL. OZ. (50 mL)

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:34.381730 · Updated: 2026-03-14T23:12:28.058882