SPL v3
SPL
SPL Set ID 30cc2e35-f752-8285-e063-6294a90afbf5
Route
TOPICAL
Published
Effective Date 2025-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (90 mg) Octisalate (45 mg) Avobenzone (27 mg) Octinoxate (70 mg) Octocrylene
Inactive Ingredients
Dimethicone Glycerin 1,2-hexanediol Centella Asiatica Leaf Water Cholesterol Acetyl Hexapeptide-8 Ceramide Np Butylene Glycol Xanthan Gum Cetearyl Alcohol Caprylyl Glycol Phytosphingosine Pentylene Glycol Ethylhexylglycerin Sodium Hyaluronate Alcohol Hyaluronic Acid Stearic Acid Panthenol Disteardimonium Hectorite Pentaerythrityl Tetraisostearate Peg-30 Dipolyhydroxystearate Ceramide Ns Propylene Carbonate Niacinamide Ceramide Ap Caprylyl Methicone Sodium Acetylated Hyaluronate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-07
Description

Avobenzone 2.7% Homosalate 9% Octinoxate 7% 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% Octinoxate 7% 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
Labels

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?

1-866-993-4709

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

Octinoxate 7%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients

WATER, DIMETHICONE, CAPRYLYL METHICONE, GLYCERIN, PENTAERYTHRITYL TETRAISOSTEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, NIACINAMIDE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, PANTHENOL, BUTYLENE GLYCOL, PROPYLENE CARBONATE, XANTHAN GUM, HYDROGENATED LECITHIN, CETEARYL ALCOHOL, STEARIC ACID, CHOLESTEROL, CENTELLA ASIATICA LEAF EXTRACT, ALCOHOL DENAT., SODIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, CERAMIDE NP, CAPRYLYL GLYCOL, CERAMIDE NS, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, PHYTOSPHINGOSINE, SODIUM ACETYLATED HYALURONATE, ACETYL HEXAPEPTIDE-8, CERAMIDE AP, CERAMIDE AS, PENTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, CERAMIDE EOP, DESAMIDO COLLAGEN, SODIUM HYALURONATE CROSSPOLYMER.

Stop Use and Ask A Doctor
  • Stop use and ask a doctor if rash occurs.
Keep Out of Reach of Children
  • Keep out of reach of children.

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
Labels

Dosage and Administration (34068-7)

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

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?

1-866-993-4709

When Using (When using)
  • When using this product keep out of eyes. Rinse with water to remove.
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%

Octinoxate 7%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients (Inactive ingredients)

WATER, DIMETHICONE, CAPRYLYL METHICONE, GLYCERIN, PENTAERYTHRITYL TETRAISOSTEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, NIACINAMIDE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, PANTHENOL, BUTYLENE GLYCOL, PROPYLENE CARBONATE, XANTHAN GUM, HYDROGENATED LECITHIN, CETEARYL ALCOHOL, STEARIC ACID, CHOLESTEROL, CENTELLA ASIATICA LEAF EXTRACT, ALCOHOL DENAT., SODIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, CERAMIDE NP, CAPRYLYL GLYCOL, CERAMIDE NS, HYALURONIC ACID, HYDROLYZED SODIUM HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, PHYTOSPHINGOSINE, SODIUM ACETYLATED HYALURONATE, ACETYL HEXAPEPTIDE-8, CERAMIDE AP, CERAMIDE AS, PENTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, CERAMIDE EOP, DESAMIDO COLLAGEN, SODIUM HYALURONATE CROSSPOLYMER.

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • Stop use and ask a doctor if rash occurs.
Keep Out of Reach of Children (Keep out of reach of children)
  • Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:03.392618 · Updated: 2026-03-14T23:08:35.242045