SPL v3
SPL
SPL Set ID 81aa38c6-61b3-4e47-9479-ef035e6a437b
Route
TOPICAL
Published
Effective Date 2015-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (20 mg) Homosalate (75 mg) Octisalate (50 mg) Octocrylene (275 mg) Oxybenzone
Inactive Ingredients
N-butylphthalimide Isopropylphthalimide Dimethicone Edetate Disodium Glycerin Phenoxyethanol Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben Polysorbate 20 Propylene Glycol Povidone, Unspecified Stearic Acid Acrylic Acid Trolamine Vinylpyrrolidone/hexadecene Copolymer Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-01
Description

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

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 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 60561-8

For external use only. Do not use on damaged or broken skin.

Warnings

Directions

  • Hold can upright. Shake well before each application.
  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.
Active Ingredients

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Butane, Butylparaben, Butylphthalimide, Dimethicone,Disodium EDTA, Ethylparaben, Glycerin, Isobutylparaben, Isopropylphthalimide, Methylparaben, Phenoxyethanol, Polysorbate-20, Propane, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Styrene/Acrylates Copolymer, Triethanolamine, VP/Hexadecene Copolymer, Water

Questions Or Comments?

Principal Display Panel 125g Can Label

SKIN HYDRATING

TOPICAL FOAM

SOLOXIDE 30

Broad Spectrum SPF 30

SUNSCREEN FOAM

Water resistant

(80 minutes)

NET WT.4.4 OZ (125g)

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 60561-8 (60561-8)

For external use only. Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings

Directions

  • Hold can upright. Shake well before each application.
  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor.
Active Ingredients (Active ingredients)

Avobenzone 2 %, Homosalate 7.5%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 2 %

Inactive Ingredients

Butane, Butylparaben, Butylphthalimide, Dimethicone,Disodium EDTA, Ethylparaben, Glycerin, Isobutylparaben, Isopropylphthalimide, Methylparaben, Phenoxyethanol, Polysorbate-20, Propane, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Styrene/Acrylates Copolymer, Triethanolamine, VP/Hexadecene Copolymer, Water

Questions Or Comments? (Questions or comments?)

Principal Display Panel 125g Can Label (PRINCIPAL DISPLAY PANEL - 125g Can Label)

SKIN HYDRATING

TOPICAL FOAM

SOLOXIDE 30

Broad Spectrum SPF 30

SUNSCREEN FOAM

Water resistant

(80 minutes)

NET WT.4.4 OZ (125g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:01.213239 · Updated: 2026-03-14T22:55:52.022027