SPL v3
SPL
SPL Set ID f07145d5-b74d-7757-e053-2a95a90ac4c0
Route
TOPICAL
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Homosalate (4 g) Octocrylene (8 g)
Inactive Ingredients
Brown Iron Oxide Butylene Glycol Theobroma Cacao Whole Limonium Gerberi Flowering Top Water O-18 Caprylic/capric/palmitic/stearic Triglyceride Titanium Dioxide Glyceryl Stearate Citrate Isododecane Glycerin Coco-caprylate Pantothenic Acid Triethoxycaprylylsilane Ferulic Acid Niacinamide Polymethylsilsesquioxane (11 Microns) Stannic Oxide Trisodium Ethylenediamine Disuccinate Peg-120 Glyceryl Stearate Lauryl Lactate Propanediol Butyloctyl Salicylate Silica, Trimethylsilyl Capped 1,2-hexanediol Caprylyl Glycol Gr-270773 Phospholipid Emulsion Helianthus Annuus Seed Wax Chlorphenesin Cetyl Phosphate Diisopropyl Sebacate Isodecyl Neopentanoate Alkyl (c12-15) Benzoate Mica Arginine Tocopherol Acrylates Crosspolymer-6 Hydroxyacetophenone Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Leuconostoc/radish Root Ferment Filtrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-15
Description

Active Ingredients Purpose Avobenzone 3%.......................................Sunscreen Homosalate 4%.......................................Sunscreen Octisalate 5%.......................................Sunscreen Octocrylene 8%.......................................Sunscreen

Medication Information

Warnings and Precautions

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply generously and evenly 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: Ask a doctor

Description

Active Ingredients Purpose Avobenzone 3%.......................................Sunscreen Homosalate 4%.......................................Sunscreen Octisalate 5%.......................................Sunscreen Octocrylene 8%.......................................Sunscreen

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6

Water, Butyloctyl Salicylate, Propanediol, Titanium Dioxide, Glycerin, C12-15 Alkyl Benzoate, Mica, Glyceryl Stearate Citrate, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Silica, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tin Oxide, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Iron Oxides, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Triethoxycaprylylsilane, Ferulic Acid

Section 51945-4



SPF 40



Dawn

Broad Spectrum Sunscreen SPF 40 PA+++

1.7 fl. oz. / 50 mL

Section 55105-1

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 55106-9

Active Ingredients Purpose

Avobenzone 3%.......................................Sunscreen

Homosalate 4%.......................................Sunscreen

Octisalate 5%.......................................Sunscreen

Octocrylene 8%.......................................Sunscreen

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 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: Ask a doctor

Warnings and Precautions (34071-1)

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Propanediol, Titanium Dioxide, Glycerin, C12-15 Alkyl Benzoate, Mica, Glyceryl Stearate Citrate, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Silica, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tin Oxide, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Iron Oxides, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Triethoxycaprylylsilane, Ferulic Acid

Section 51945-4 (51945-4)



SPF 40



Dawn

Broad Spectrum Sunscreen SPF 40 PA+++

1.7 fl. oz. / 50 mL

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3%.......................................Sunscreen

Homosalate 4%.......................................Sunscreen

Octisalate 5%.......................................Sunscreen

Octocrylene 8%.......................................Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:40.157583 · Updated: 2026-03-14T23:05:33.999008