SPL v1
SPL
SPL Set ID 34cc5b3c-af36-e202-e063-6294a90a13a7
Route
TOPICAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Avobenzone (3 g) Octocrylene (5 g) Octisalate
Inactive Ingredients
Ethylhexylglycerin Glyceryl Stearate Caprylyl Methicone Cetyl Alcohol Peg-100 Stearate Sodium Hydroxide Paeonia Lactiflora Root Acetyl Heptapeptide-4 Polymethylsilsesquioxane (11 Microns) Steareth-20 Silanetriol Caprylyl Glycol Sodium Polyacrylate (8000 Mw) Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ceteth-20 Cyclopentasiloxane Edetate Disodium Xanthan Gum Peg/ppg-18/18 Dimethicone Hyaluronic Acid Ci 77492 Ci 77491 Calcium Chloride Pentylene Glycol N-prolyl Palmitoyl Tripeptide-56 Acetate Colloidal Gold Propanediol Dimethicone 200 Phenoxyethanol Potassium Cetyl Phosphate Castor Oil/ipdi Copolymer Isopropyl Titanium Triisostearate Glycerin Dicaprylyl Carbonate Caprylic/capric Triglyceride Trideceth-6 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-27
Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Ocrocrylene 10%

Medication Information

Warnings and Precautions

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.

Indications and Usage

Helps prevent sunscreen

Dosage and Administration

For sunscreen use:

Apply liberally 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 risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

limit time in the sun, especially from 10 am to 2 pm

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

Children under 6 months: ask a doctor.

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Ocrocrylene 10%

Section 50565-1

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

Section 51727-6

Water, Glycerin, Dicaprylyl Carbonate, Polymethylsilsesquioxane, Caprylic/Capric Triglyerice, Caprylyl Mthicone, Phenoxyethanol, Glyceryl Stearate, Cetyl Alcohol, Potassium Cetyl Phosphate, Sodium Polyacrylate, Dimethicone, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Ceteth-20, Cyclopentasiloxane, Disodium EDTA, Steareth-20, Ethylhexylglycerin, Sodium Hydroxide, Paeonia Albiflora Root Extract, PEG/PPG-18/19 Dimethicone, Trideceth-6, Hyaluronic Acid, Silanetriol, Iron Oxides (CI 77492, CI 77491), Calcium Chloride, N-Propyl Palmitoyl Tripeptide-56 Acetate, Bis-Hydroxyethoxypropyl Dimethicone/PEG-2 Soyamine/IPDI Copolymer, Isopropyl Titanium Triisostearate, Colloidal Gold, Acetyl Heptapeptide-9, Pentylene Glycol, Caprylyl Glycol, Propanediol, Bid-PEG-15 Dimethicon/IPDI Copolymer, PEG-2 Soyamine.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Ocrocrylene 10%

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunscreen

Dosage and Administration (34068-7)

For sunscreen use:

Apply liberally 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 risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

limit time in the sun, especially from 10 am to 2 pm

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

Children under 6 months: ask a doctor.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Glycerin, Dicaprylyl Carbonate, Polymethylsilsesquioxane, Caprylic/Capric Triglyerice, Caprylyl Mthicone, Phenoxyethanol, Glyceryl Stearate, Cetyl Alcohol, Potassium Cetyl Phosphate, Sodium Polyacrylate, Dimethicone, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Ceteth-20, Cyclopentasiloxane, Disodium EDTA, Steareth-20, Ethylhexylglycerin, Sodium Hydroxide, Paeonia Albiflora Root Extract, PEG/PPG-18/19 Dimethicone, Trideceth-6, Hyaluronic Acid, Silanetriol, Iron Oxides (CI 77492, CI 77491), Calcium Chloride, N-Propyl Palmitoyl Tripeptide-56 Acetate, Bis-Hydroxyethoxypropyl Dimethicone/PEG-2 Soyamine/IPDI Copolymer, Isopropyl Titanium Triisostearate, Colloidal Gold, Acetyl Heptapeptide-9, Pentylene Glycol, Caprylyl Glycol, Propanediol, Bid-PEG-15 Dimethicon/IPDI Copolymer, PEG-2 Soyamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Ocrocrylene 10%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:06.525826 · Updated: 2026-03-14T23:08:42.212838