SPL v7
SPL
SPL Set ID 865057ce-f617-4232-a60e-e23c120b0a73
Route
TOPICAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (5 g) Octisalate (7 g) Octocrylene
Inactive Ingredients
Water Glycerin Shea Butter Dimethicone Ethylhexylglycerin Benzyl Alcohol Glyceryl Monostearate Peg-100 Stearate Arachidyl Alcohol Saccharide Isomerate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Docosanol Isohexadecane Niacinamide Hydroxyethyl Urea Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) .alpha.-tocopherol Acetate Arginine Chlorphenesin Arachidyl Glucoside Edetate Disodium Panthenol Avocado Oil Sorbitan Isostearate Polysorbate 60 Olive Oil Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Limonene, (+)- .beta.-citronellol, (+/-)- Linalool, (+/-)- Geraniol Eugenol Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01 Until 2025-07-01
Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% 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 42229-5

Questions? Call 1-800-551-2345 or visit www.jafra.com

Warnings

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.

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.

Directions

• Apply liberally and evenly 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor

• 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 your time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

Product Label

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

Water, Glycerin, Polyester-8, Butyrospermum Parkii (Shea) Butter, Dimethicone, Styrene/Acrylates Copolymer, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Saccharide Isomerate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Limonene, Behenyl Alcohol, Isohexadecane, Niacinamide, Hydroxyethyl Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Arginine, Chlorphenesin, Arachidyl Glucoside, Disodium EDTA, Panthenol, Fragrance, Persea Gratissima (Avocado) Oil, Phytosterols, Sorbitan Isostearate, Polysorbate 60, Olea Europaea (Olive) Fruit Oil, Linalool, Citronellol, Geraniol, Eugenol, Citral

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 42229-5 (42229-5)

Questions? Call 1-800-551-2345 or visit www.jafra.com

Purpose

Sunscreen

Warnings

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.

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.

Directions

• Apply liberally and evenly 15 minutes before sun exposure

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor

• 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 your time in the sun, especially from 10 a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

Product Label (Product label)

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Polyester-8, Butyrospermum Parkii (Shea) Butter, Dimethicone, Styrene/Acrylates Copolymer, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Saccharide Isomerate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Limonene, Behenyl Alcohol, Isohexadecane, Niacinamide, Hydroxyethyl Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Arginine, Chlorphenesin, Arachidyl Glucoside, Disodium EDTA, Panthenol, Fragrance, Persea Gratissima (Avocado) Oil, Phytosterols, Sorbitan Isostearate, Polysorbate 60, Olea Europaea (Olive) Fruit Oil, Linalool, Citronellol, Geraniol, Eugenol, Citral

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.978796 · Updated: 2026-03-14T23:13:25.872506