Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 5712df74-5201-474b-bbfd-703f3117bd9c
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Ethylhexyl Salicylate (50 mg)
Inactive Ingredients
Water Glycerin C15-19 Alkane Propanediol Ethylhexyl Methoxycrylene Butyloctyl Salicylate Sodium Stearoyl Glutamate Tocopherol Cetearyl Alcohol Sclerotium Gum Sodium Hydroxide Phenoxyethanol Hydroxyacetophenone Caprylyl Glycol Glyceryl Stearate Helianthus Annuus (sunflower) Seed Wax Soybean Oil Trisodium Ethylenediamine Disuccinate Bisabolol Pentylene Glycol Propylene Glycol Taraxacum Officinale Root Polyglycerin-3 Green Tea Leaf Medicago Sativa Whole Chamomile Limonene, (+)- Sodium Benzoate Potassium Sorbate Kale Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-15
Description

Avobenzone 3% Homosalate 15% Octisalate 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5%

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:

  • shake well before 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

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Inactive Ingredients

water, glycerin, C15-19 alkane, propanediol, ethylhexyl methoxycrylene, butyloctyl salicylate, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, sodium stearoyl glutamate, tocopherol, cetearyl alcohol, sclerotium gum, sodium hydroxide, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annus (sunflower) seed wax, hydroxypropyl starch phosphate, glycine soja (soybean) oil, trisodium ethylenediamine disuccinate, polyglycerin-3

Questions Or Comments?

PO Box 98 Westfield, NJ 07091

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If 

rash occurs

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:

  • shake well before 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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

water, glycerin, C15-19 alkane, propanediol, ethylhexyl methoxycrylene, butyloctyl salicylate, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, sodium stearoyl glutamate, tocopherol, cetearyl alcohol, sclerotium gum, sodium hydroxide, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annus (sunflower) seed wax, hydroxypropyl starch phosphate, glycine soja (soybean) oil, trisodium ethylenediamine disuccinate, polyglycerin-3

Questions Or Comments? (Questions or comments?)

PO Box 98 Westfield, NJ 07091

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

rash occurs

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:25.487107 · Updated: 2026-03-14T23:09:12.253423