SPL v2
SPL
SPL Set ID 30c83f4f-9de0-6fbf-e063-6394a90af1ae
Route
TOPICAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (27 mg) Octisalate (45 mg) Octocrylene (90 mg) Homosalate
Inactive Ingredients
1,2-hexanediol Inulin Lauryl Carbamate Xanthan Gum Ceramide Ns Phytosphingosine Ceramide Ap Pentylene Glycol Potassium Cetyl Phosphate Trisodium Edta Ceramide Np Cetearyl Olivate Caprylyl Glycol Acetyl Hexapeptide-8 Panthenol Isododecane Glyceryl Stearate Nutmeg Water Cetyl Alcohol Dimethicone Glyceryl Caprylate Cetearyl Alcohol Stearic Acid Cholesterol Sodium Hyaluronate Sodium Acetylated Hyaluronate Sodium Polyacryloyldimethyl Taurate Centella Asiatica Leaf Ethylhexylglycerin Caprylic/capric Triglyceride Butylene Glycol Sorbitan Olivate Niacinamide Propanediol Hyaluronic Acid Glycerin Dehydrated Alcohol Tromethamine Magnesium Aluminum Silicate Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Butyl Acrylate/methyl Methacrylate/trimethylsiloxymethacrylate Copolymer Ceramide 4 Hydrogenated Soybean Lecithin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-21
Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Dosage and Administration

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

Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

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 50565-1

Keep out of reach of children.

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 51945-4

Warnings

For external use only.

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.
  • Gently shake before use.
Do Not Use

Do not use on damaged or broken skin.

Questions?

1-800-FOR-AVON

Other Information
  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics
Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients

WATER, DIMETHICONE, GLYCERIN, NIACINAMIDE, PROPANEDIOL, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, 1,2-HEXANEDIOL, CETYL ALCOHOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, BUTYLENE GLYCOL, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, TROMETHAMINE, XANTHAN GUM, HYDROGENATED LECITHIN, MAGNESIUM ALUMINUM SILICATE, TRISODIUM EDTA, STEARIC ACID, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, CHOLESTEROL, CENTELLA ASIATICA LEAF EXTRACT, ALCOHOL DENAT., CERAMIDE NP, CAPRYLYL GLYCOL, SODIUM HYALURONATE, CERAMIDE NS, HYDROLYZED HYALURONIC ACID, PHYTOSPHINGOSINE, ACETYL HEXAPEPTIDE-8, CERAMIDE AP, CERAMIDE AS, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, PENTYLENE GLYCOL, CERAMIDE EOP, DESAMIDO COLLAGEN, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE CROSSPOLYMER.

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
Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

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.
  • Gently shake before use.
Do Not Use (Do not use)

Do not use on damaged or broken skin.

Questions?

1-800-FOR-AVON

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • the product may stain certain types of fabrics
Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients

WATER, DIMETHICONE, GLYCERIN, NIACINAMIDE, PROPANEDIOL, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, 1,2-HEXANEDIOL, CETYL ALCOHOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, BUTYLENE GLYCOL, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, TROMETHAMINE, XANTHAN GUM, HYDROGENATED LECITHIN, MAGNESIUM ALUMINUM SILICATE, TRISODIUM EDTA, STEARIC ACID, MYRISTICA FRAGRANS (NUTMEG) EXTRACT, CHOLESTEROL, CENTELLA ASIATICA LEAF EXTRACT, ALCOHOL DENAT., CERAMIDE NP, CAPRYLYL GLYCOL, SODIUM HYALURONATE, CERAMIDE NS, HYDROLYZED HYALURONIC ACID, PHYTOSPHINGOSINE, ACETYL HEXAPEPTIDE-8, CERAMIDE AP, CERAMIDE AS, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, PENTYLENE GLYCOL, CERAMIDE EOP, DESAMIDO COLLAGEN, ETHYLHEXYLGLYCERIN, SODIUM HYALURONATE CROSSPOLYMER.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:09.373142 · Updated: 2026-03-14T23:08:46.104923