1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f

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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

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

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
Other Information

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

Description

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

Do Not Use
  • on damaged or broken skin
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

Warnings

For external use only

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

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
Other Information (Other information)

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

Do Not Use (Do not use)
  • on damaged or broken skin
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