SPL v3
SPL
SPL Set ID 33d1a5da-68c3-b16e-e063-6294a90a7006
Route
TOPICAL
Published
Effective Date 2025-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (65 mg) Avobenzone (28 mg) Octocrylene (80 mg) Octisalate (45 mg)
Inactive Ingredients
Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Glycerin Isododecane Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Dextrin Palmitate (corn; 20000 Mw) Dibutyl Adipate Cananga Odorata Flower Oil Polyphenylsilsesquioxane (ri 1.55) Ectoine .alpha.-tocopherol Acetate Squalane Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Jasminum Officinale Flower Butyloctyl Salicylate Sodium Hyaluronate Trimethylsiloxysilicate (m/q 0.6-0.8) Cedrus Atlantica Bark Oil Tocopherol Benzotriazolyl Dodecyl P-cresol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-30
Description

Active Ingredient Homosalate 6.50%, Octocrylene 8.00%, Octisalate 4.50%, Avobenzone 2.80%

Medication Information

Warnings and Precautions

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.

Indications and Usage
  • 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
Dosage and Administration

Directions

1.Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every two hours

2.Use a water-resistant sunscreen if swimming or sweating

3.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

4.Children under 6 months of age: Ask a doctor

Description

Active Ingredient Homosalate 6.50%, Octocrylene 8.00%, Octisalate 4.50%, Avobenzone 2.80%

Section 50565-1

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.

Section 50566-9

Stop use

Stop use and ask a doctor if rash occurs

Section 50567-7

When using

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

Section 50570-1

Do not use

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredient

Isododecane, Butyloctyl Salicylate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dextrin Palmitate, Dibutyl Adipate, Methyl Methacrylate Crosspolymer, Acrylates Copolymer, Benzotriazolyl Dodecyl p-Cresol, Polyphenylsilsesquioxane, Trimethylsiloxysilicate, Cedrus Atlantica Bark Oil, Tocopherol, Cananga Odorata Flower Oil, Glycerin, Squalane, Tocopheryl Acetate, Jasminum

Officinale (Jasmine) Oil, Ectoin, Sodium Hyaluronate

Section 51945-4

Abib

Airy clear sunscreen gel

smoothing tube

Broad Spectrum SPF 30

1.01 FL. OZ. 30 mL

Section 55105-1

Uses

1.Helps prevent sunburn

2.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 Ingredient

Homosalate 6.50%,

Octocrylene 8.00%,

Octisalate 4.50%,

Avobenzone 2.80%

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

Directions

1.Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every two hours

2.Use a water-resistant sunscreen if swimming or sweating

3.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

4.Children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using

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

Section 50570-1 (50570-1)

Do not use

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredient

Isododecane, Butyloctyl Salicylate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Dextrin Palmitate, Dibutyl Adipate, Methyl Methacrylate Crosspolymer, Acrylates Copolymer, Benzotriazolyl Dodecyl p-Cresol, Polyphenylsilsesquioxane, Trimethylsiloxysilicate, Cedrus Atlantica Bark Oil, Tocopherol, Cananga Odorata Flower Oil, Glycerin, Squalane, Tocopheryl Acetate, Jasminum

Officinale (Jasmine) Oil, Ectoin, Sodium Hyaluronate

Section 51945-4 (51945-4)

Abib

Airy clear sunscreen gel

smoothing tube

Broad Spectrum SPF 30

1.01 FL. OZ. 30 mL

Section 55105-1 (55105-1)

Uses

1.Helps prevent sunburn

2.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 Ingredient

Homosalate 6.50%,

Octocrylene 8.00%,

Octisalate 4.50%,

Avobenzone 2.80%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:34.790877 · Updated: 2026-03-14T23:11:11.874697