SPL v5
SPL
SPL Set ID 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f
Route
TOPICAL
Published
Effective Date 2018-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Octinoxate (75 mg) Octisalate (50 mg)
Inactive Ingredients
Water Cyclomethicone 5 Polymethylsilsesquioxane (4.5 Microns) Polysilicone-15 Tribehenin Olive Oil Rosa X Damascena Flowering Top Calcium Carbonate Yellow Wax Pollen Propolis Wax Silicon Dioxide .alpha.-tocopherol Acetate Phenoxyethanol Sodium Dehydroacetate Dimethicone Hyaluronate Sodium Panthenol Edetate Sodium Aminomethylpropanol Allantoin Magnesium Aluminum Silicate Sodium Ascorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01
Description

Avobenzone 3% Homosalate 15% Octinoxate 7.5% Octisalate 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octinoxate 7.5% Octisalate 5%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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: Sun Protection Measures.

  • 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 the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3% Homosalate 15% Octinoxate 7.5%



Octisalate 5%

Inactive Ingredients?

Water, Cyclopentasiloxane, Polymethylsilsesquioxane, Polysilicone-15, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Tribehenin, Olive (Olea europaea) Fruit Oil, Damask Rose (Rosa damascena) Flower Oil, Calcium Carbonate, Beeswax, Pollen, Propolis, Silica, Tocopheryl Acetate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Dehydroacetate, Dimethicone, Sodium Hyaluronate, Panthenol, Dimethiconol, Tetrasodium EDTA, Aminomethyl Propanol, Allantoin, Magnesium Aluminum Silicate, Sodium Ascorbate

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

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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: Sun Protection Measures.

  • 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 (Other information)

Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3% Homosalate 15% Octinoxate 7.5%



Octisalate 5%

Inactive Ingredients? (Inactive ingredients?)

Water, Cyclopentasiloxane, Polymethylsilsesquioxane, Polysilicone-15, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Tribehenin, Olive (Olea europaea) Fruit Oil, Damask Rose (Rosa damascena) Flower Oil, Calcium Carbonate, Beeswax, Pollen, Propolis, Silica, Tocopheryl Acetate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Dehydroacetate, Dimethicone, Sodium Hyaluronate, Panthenol, Dimethiconol, Tetrasodium EDTA, Aminomethyl Propanol, Allantoin, Magnesium Aluminum Silicate, Sodium Ascorbate

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

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Source: dailymed · Ingested: 2026-02-15T12:08:19.359304 · Updated: 2026-03-14T23:12:31.383435