SPL v3
SPL
SPL Set ID cea54600-5308-4b9f-98ca-fef0b26d79c1
Route
TOPICAL
Published
Effective Date 2025-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octocrylene (5 g) Zinc Cation (5.8 g)
Inactive Ingredients
Triethoxycaprylylsilane Water Ethylhexyl Stearate Isopropyl Palmitate Sunflower Oil Monoglycerides Microcrystalline Wax Cetyl Dimethicone 150 Hydrogenated Polyisobutene (450 Mw) Polyglyceryl-4 Isostearate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Hexyl Laurate Methylisothiazolinone Caprylyl Glycol Sodium Chloride Cyclomethicone 5 Cyclomethicone 6 Hydrogenated Castor Oil Aloe Vera Leaf Juice Silicon Dioxide Polyglyceryl-3 Oleate

Identifiers & Packaging

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

Description

Homosalate  10%                           Octocrylene  5% Zinc Oxide   5.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate  10%                           Octocrylene  5% Zinc Oxide   5.8%

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 (754) 214-9379

Section 50565-1

Warnings

For external use only.

Stop use and ask a doctorif rash or irritation develops and lasts.

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 help or contact a Poison 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.

Inactive Ingredients

Triethoxycaprylylsilane, Water, Ethylhexyl Stearate, Isopropyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated Polyisobutene , Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Methylisothiazolinone, Caprylyl Glycol, Sodium Chloride, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Silica, Polyglyceryl-3 Oleate

Active Ingredients                    

Homosalate  10%                          

Octocrylene  5%

Zinc Oxide   5.8%


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 (754) 214-9379

Section 50565-1 (50565-1)

Purpose

Sunscreen

Warnings

For external use only.

Stop use and ask a doctorif rash or irritation develops and lasts.

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 help or contact a Poison 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.

Inactive Ingredients

Triethoxycaprylylsilane, Water, Ethylhexyl Stearate, Isopropyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated Polyisobutene , Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Methylisothiazolinone, Caprylyl Glycol, Sodium Chloride, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Silica, Polyglyceryl-3 Oleate

Active Ingredients                    

Homosalate  10%                          

Octocrylene  5%

Zinc Oxide   5.8%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)