SPL v3
SPL
SPL Set ID 20538bc0-10c3-492c-952a-6797e46003f2
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (5 g) Ethylhexyl Salicylate (7 g) Homosalate
Inactive Ingredients
Alcohol Coconut Oil .alpha.-tocopherol Acetate Dibutyl Maleate Tetrahexyldecyl Ascorbate Glycerin Butylene Glycol Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Polysorbate 20 Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-19

Description

Homosalate 7% Octisalate 5%                           Octocrylene 5% Avobenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 7% Octisalate 5%                           Octocrylene 5% Avobenzone 3%

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

Questions or Comments?

Call 1 (561) 503-6592

Section 50565-1

Warnings

For external use only.

Stop use and ask a doctorif rash occurs.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

Keep out of reach of children. If product is swallowed, get medical he$ or contact a Po1son Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

• Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• at least every 2 hours.

• Children under 6 months: Ask a doctor.

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 Broad Spectrum of 15 or nigher and other sun protection measures, including:

• limit time in the sun, espec1ally from 10 a.m.- 2 p.m.

• wear long sleeve shirts, pants, hats & sunglasses

Product Label

Other Information

• protect this product from heat and direct sun.

• may stain or damage some fabrics or surfaces.

Inactive Ingredients

SD Alcohol 40-8, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Coconut Oil, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1 , Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycerin, Water, Carbomer, Butylene Glycol, Polysorbate 20

Active Ingredients                    

Homosalate 7%

Octisalate 5%                          

Octocrylene 5%

Avobenzone 3%


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)

Questions or Comments?

Call 1 (561) 503-6592

Section 50565-1 (50565-1)

Purpose

Sunscreen

Warnings

For external use only.

Stop use and ask a doctorif rash occurs.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

Keep out of reach of children. If product is swallowed, get medical he$ or contact a Po1son Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

• Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• at least every 2 hours.

• Children under 6 months: Ask a doctor.

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 Broad Spectrum of 15 or nigher and other sun protection measures, including:

• limit time in the sun, espec1ally from 10 a.m.- 2 p.m.

• wear long sleeve shirts, pants, hats & sunglasses

Product Label (Product label)

Other Information

• protect this product from heat and direct sun.

• may stain or damage some fabrics or surfaces.

Inactive Ingredients

SD Alcohol 40-8, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance, Coconut Oil, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1 , Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycerin, Water, Carbomer, Butylene Glycol, Polysorbate 20

Active Ingredients                    

Homosalate 7%

Octisalate 5%                          

Octocrylene 5%

Avobenzone 3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)