4526bacf-6451-b297-e063-6294a90af71a

SPL v2
SPL
SPL Set ID 4526bacf-6451-b297-e063-6294a90af71a
Route
topical
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (45 mg) octocrylene (100 mg) homosalate (140 mg) avobenzone (28 mg)
Inactive Ingredients
butyloctyl salicylate ethylhexylglycerin tromethamine ecklonia cava hyaluronic acid ammonium acryloyldimethyltaurate/vp copolymer xanthan gum vinylpyrrolidone/eicosene copolymer polyether-1 (2800 mpa.s) portulaca oleracea whole t-butyl alcohol panthenol methylpropanediol codium fragile butylene glycol cetearyl alcohol polyacrylate crosspolymer-6 propanediol dibutyl adipate glyceryl stearate undaria pinnatifida tocopherol biosaccharide gum-1 spirulina platensis pentylene glycol water sorbitan olivate cetearyl olivate caprylyl methicone 1,2-hexanediol glycerin polymethylsilsesquioxane (4.5 microns) potassium cetyl phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-03
Description

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

Medication Information

Warnings and Precautions
  • 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.
  • Keep out of reach of children.
Active Ingredient

Homosalate 14.00%

Octocrylene 10.00%

Octisalate 4.50%

Avobenzone 2.80%

Indications and Usage
  • Helps prevent sunburn
  • When used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration
  • Apply generously and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
Description

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

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

No “Do not use” statements apply for this product when used as directed.

Section 51727-6

Water (Aqua)

Glycerin

Butyloctyl Salicylate

Propanediol

Dibutyl Adipate

Polymethylsilsesquioxane

Cetearyl Olivate

Caprylyl Methicone

1,2-Hexanediol

Pentylene Glycol

VP/Eicosene Copolymer

Sorbitan Olivate

Potassium Cetyl Phosphate

Panthenol

Glyceryl Stearate

Butylene Glycol

Cetearyl Alcohol

Polyacrylate Crosspolymer-6

Methylpropanediol

Ammonium Acryloyldimethyltaurate/VP Copolymer

Xanthan Gum

Ethylhexylglycerin

Undaria Pinnatifida Extract

Tromethamine

Spirulina Platensis Extract

Plankton Extract

Ecklonia Cava Extract

Codium Fragile Extract

Hyaluronic Acid

Polyether-1

Portulaca Oleracea Extract

Beta-Glucan

T-Butyl Alcohol

Tocopherol

Biosaccharide Gum-1

Section 51945-4

Image of immediate container labeling (inner tube), 50 mL, NDC 87225-001-01

Section 55105-1

Sunscreen

Structured Label Content

Warnings and Precautions (34071-1)
  • 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.
  • Keep out of reach of children.
Active Ingredient (55106-9)

Homosalate 14.00%

Octocrylene 10.00%

Octisalate 4.50%

Avobenzone 2.80%

Indications and Usage (34067-9)
  • Helps prevent sunburn
  • When used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage and Administration (34068-7)
  • Apply generously and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
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 50570-1 (50570-1)

No “Do not use” statements apply for this product when used as directed.

Section 51727-6 (51727-6)

Water (Aqua)

Glycerin

Butyloctyl Salicylate

Propanediol

Dibutyl Adipate

Polymethylsilsesquioxane

Cetearyl Olivate

Caprylyl Methicone

1,2-Hexanediol

Pentylene Glycol

VP/Eicosene Copolymer

Sorbitan Olivate

Potassium Cetyl Phosphate

Panthenol

Glyceryl Stearate

Butylene Glycol

Cetearyl Alcohol

Polyacrylate Crosspolymer-6

Methylpropanediol

Ammonium Acryloyldimethyltaurate/VP Copolymer

Xanthan Gum

Ethylhexylglycerin

Undaria Pinnatifida Extract

Tromethamine

Spirulina Platensis Extract

Plankton Extract

Ecklonia Cava Extract

Codium Fragile Extract

Hyaluronic Acid

Polyether-1

Portulaca Oleracea Extract

Beta-Glucan

T-Butyl Alcohol

Tocopherol

Biosaccharide Gum-1

Section 51945-4 (51945-4)

Image of immediate container labeling (inner tube), 50 mL, NDC 87225-001-01

Section 55105-1 (55105-1)

Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:53.442352 · Updated: 2026-03-14T23:11:51.346073