Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bff60c2f-0cc6-493b-81a0-ed35e9746146
Route
TOPICAL
Published
Effective Date 2025-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30.0 mg) Homosalate (70.0 mg) Ethylhexyl Salicylate (40.0 mg) Octocrylene
Inactive Ingredients
Water Coco-caprylate/caprate Tribehenin Peg-20 Esters Glycerin Copernicia Cerifera (carnauba) Wax Silica Ethylhexylglycerin Caprylic/capric Triglyceride Phenoxyethanol Benzyl Alcohol Soybean Oil Tocopherol Panthenol Lavandula Angustifolia (lavender) Oil Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Rosmarinus Officinalis (rosemary) Leaf Oil Sodium Stearoyl Glutamate Trisodium Ethylenediamine Disuccinate Microcrystalline Cellulose Sodium Dehydroacetate .alpha.-tocopherol Acetate, D- Cedrus Atlantica Bark Oil Sodium Hydroxide Cellulose Gum Sodium Carrageenan Green Tea Leaf Sea Salt Lactic Acid, Dl- Sodium Benzoate Beta-carotene Carrot Potassium Sorbate Linalool Limonene, (+/-)- Geraniol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Avobenzone 3% Homosalate 7% Octisalate 4% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 7% Octisalate 4% Octocrylene 7%

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 51945-4

Warnings

For external use only.

Directions

For sunscreen use:

  • apply generously 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a Broad Spectrum SPF value of

15 or higher and other sun protection measures

including:

• 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.
  • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.
Active Ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 4%

Octocrylene 7%

Inactive Ingredients

water, coco-caprylate/caprate, tribehenin

PEG-20 esters, glycerin, copernicia

cerifera (carnauba) wax, silica,

ethylhexylglycerin, caprylic/capric

triglyceride, phenoxyethanol, benzyl

alcohol, glycine soja (soybean) oil,

tocopherol, panthenol, lavandula

angustifolia (lavender) oil, acrylates/

C10-30 alkyl acrylate crosspolymer,

rosmarinus officinalis (rosemary)

leaf oil, sodium stearoyl glutamate,

trisodium ethylenediamine disuccinate,

microcrystalline cellulose, sodium

dehydroacetate, tocopheryl acetate,

cedrus atlantica (cedarwood) bark

oil, sodium hydroxide, cellulose gum,

sodium carrageenan, camellia sinensis

leaf extract, sea salt (maris sal), lactic

acid, sodium benzoate, beta-carotene,

daucus carota sativa (carrot) root extract,

potassium sorbate, linalool, limonene,

geraniol

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 Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions

For sunscreen use:

  • apply generously 15 minutes before sun exposure.
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a Broad Spectrum SPF value of

15 or higher and other sun protection measures

including:

• 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.
  • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 7%

Octisalate 4%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, coco-caprylate/caprate, tribehenin

PEG-20 esters, glycerin, copernicia

cerifera (carnauba) wax, silica,

ethylhexylglycerin, caprylic/capric

triglyceride, phenoxyethanol, benzyl

alcohol, glycine soja (soybean) oil,

tocopherol, panthenol, lavandula

angustifolia (lavender) oil, acrylates/

C10-30 alkyl acrylate crosspolymer,

rosmarinus officinalis (rosemary)

leaf oil, sodium stearoyl glutamate,

trisodium ethylenediamine disuccinate,

microcrystalline cellulose, sodium

dehydroacetate, tocopheryl acetate,

cedrus atlantica (cedarwood) bark

oil, sodium hydroxide, cellulose gum,

sodium carrageenan, camellia sinensis

leaf extract, sea salt (maris sal), lactic

acid, sodium benzoate, beta-carotene,

daucus carota sativa (carrot) root extract,

potassium sorbate, linalool, limonene,

geraniol

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (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)