Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Over-the-counter medicine · no prescription needed

Avobenzone, octinoxate, octisalate, octocrylene and oxybenzone

Purpose on the label: Sunscreen

Sunscreens

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Avobenzone, octinoxate, octisalate, octocrylene and oxybenzone used for?
The Drug Facts label of Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30 (Flageoli Limited) lists these 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.
Do I need a prescription for Avobenzone, octinoxate, octisalate, octocrylene and oxybenzone?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Avobenzone, octinoxate, octisalate, octocrylene and oxybenzone been recalled?
No recall linked to these products appears in the FDA enforcement reports we use.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30 · Flageoli Limited

Avobenzone 30 mg/mL · Octinoxate 75 mg/mL · Octisalate 50 mg/mL · Octocrylene 27 mg/mL · Oxybenzone 50 mg/mL, cream (topical)

Active ingredient

Avobenzone 3% Octocrylene 2.7% Octinoxate 7.5% Octisalate 5% Oxybenzone 5% Purpose Sunscreen

Purpose

Sunscreen

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

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 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 10a.m. – 2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Potassium Cetyl Phosphate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Tocopherol, Anogeissus Leiocarpus Bark Extract, Citrus Nobilis (Mandarin Orange) Peel Extract, Citrus Limon (Lemon) Fruit Extract, Malpighia Glabra (Acerola) Fruit Extract, Hydrolyzed Collagen, Maltodextrin, Urea, Alpha-Glucan Oligosaccharide, Creatine, Citrus Aurantifolia (Lime) Fruit Extract, Lactic Acid, Ascorbic Acid, Hydroxyapatite, Glutathione, Cysteine, Hydrolyzed Vegetable Protein, Passiflora Incarnata Extract, Hydroxyethylcellulose, Magnesium Aluminum Silicate, Sodium Ascorbyl Phosphate, Caprylyl Glycol, Sodium Citrate, Sodium Polyacrylate, Disodium Edta, Propanediol, Pentylene Glycol, Butylene Glycol, Lecithin, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tetrahexyldecyl Ascorbate, 3-O-Ethyl Ascorbic Acid, Magnesium Ascorbyl Phosphate, Potassium Ascorbyl Tocopheryl Phosphate, Magnesium Aspartate, Zinc Gluconate, Ethoxydiglycol, Zeolite, Silica, Sodium Chloride, Tetrasodium Glutamate Diacetate, Calcium Gluconate, Copper Gluconate, Acetyl Tetrapeptide-17 (and) Platinum, Ethylhexylglycerin, Citric Acid, Parfum (Fragrance), Phenoxyethanol, Sodium

— FDA label of Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30, Flageoli Limited, effective February 4, 2026. See the official label on DailyMed →

Cannon Balm 140 · Duke Cannon Supply Co.

Avobenzone 0.51 g/17 g · Octinoxate 1.28 g/17 g · Octisalate 0.85 g/17 g · Octocrylene 0.85 g/17 g · Oxybenzone 1.02 g/17 g, stick (topical)

Active ingredient

Avobenzone 3% Octinoxate 7.5% Octisalate 5% Octocrylene 5% Oxybenzone 6%

Purpose

Sunscreen Sunscreen Sunscreen Sunscreen Sunscreen

Uses

  • helps prevent sunburn

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 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 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 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

Inactive ingredients

olea europaea (olive) oil*, oryza sativa (rice bran) wax, hydroxystearic/linoleic/oleic polyglycerides, ceresin wax, cera flava (beeswax)*, polyisobutene, hydrated silica, citrus aurantium dulcis (blood orange) oil, mentha piperita (peppermint) oil*, melaleuca alternifolia (tea tree) oil*, adansonia digitata (baobab) oil*, natural flavor, tocopherol (vitamin e), rosmarinus officinalis (rosemary) extract*, calendula officinalis extract*, stevia rebaudiana* *organic ingredient

Questions?

1-855-354-4438

— FDA label of Cannon Balm 140, Duke Cannon Supply Co., effective December 3, 2025. See the official label on DailyMed →

Ceramide Premiere Broad Spectrum Spf 30 · Revlon

Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.3% · Oxybenzone 0.4%, emulsion (topical)

Active ingredient

Purpose Active Ingredients Purpose OCTINOXATE 7.5% ....... Sunscreen OCTISALATE 5.0%........ Sunscreen OXYBENZONE 4.0%........ Sunscreen OCTOCRYLENE 3.0%. ...... Sunscreen AVOBENZONE 2.0%....... Sunscreen

Purpose

Sunscreen

Uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun

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 product is swallowed, get medical help or contact a Poison Control Center right away. Directions For Sunscreen Use - Apply liberally 15 minutes before sun exposure - Reapply: - at least every 2 hours - 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 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-sleeve shirts, pants, hats, and sunglasses - Children under 6 months: Ask a doctor.

Directions

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours

Inactive ingredients

WATER/AQUA/EAU, DIMETHICONE, GLYCERIN, HYDROGENATED POLYISOBUTENE, PETROLATUM, GLYCERYL STEARATE, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROGENATED LECITHIN, DIMETHYL CAPRAMIDE, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, FUCUS SERRATUS EXTRACT, YEAST EXTRACT/FAEX/EXTRAIT DE LEVURE, RETINYL LINOLEATE, TOCOPHERYL ACETATE, CETEARYL DIMETHICONE CROSSPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, SOY AMINO ACIDS, 3-AMINOPROPANE SULFONIC ACID, CALCIUM HYDROXYMETHIONINE, HYDROLYZED SOY PROTEIN, METHYL METHACRYLATE CROSSPOLYMER, PHYTOSPHINGOSINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, PEG-8 LAURATE, POLYSORBATE 20, SODIUM DODECYLBENZENESULFONATE, STYRENE/ACRYLATES COPOLYMER, BEHENYL ALCOHOL, PENTYLENE GLYCOL, CARBOMER, HYDROXYETHYLCELLULOSE, POLYETHYLENE, XANTHAN GUM, EDTA, SODIUM HYDROXIDE, BHT, DISODIUM EDTA, MICA, TIN OXIDE, AMINOPROPYL DIMETHICONE, FRAGRANCE/PARFUM, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYCITRONELLAL, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891).

— FDA label of Ceramide Premiere Broad Spectrum Spf 30, Revlon, effective December 29, 2025. See the official label on DailyMed →

Advanced Anti-Wrinkle Therapy Cicatricure · Genomma Lab

Avobenzone 3% · Octinoxate 7.5% · Octisalate 5% · Octocrylene 2.7% · Oxybenzone 4%, cream (topical)

Active ingredient

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

Purpose

Sunscreen

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

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

For sunscreen use :

  • 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 factor of 15 or higher and other skin protection measures including:
  • limit time in the sun, especially from 10am to 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive ingredients

Water, Glycerin, Dimethicone, Ethylhexyl Methoxycrylene, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Butylene Glycol, Isostearyl Neopentanoate, PPG-2 Isoceteth-20 Acetate, Polymethyl Methacrylate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Bakuchiol, Retinyl Palmitate, Tocopheryl Acetate, Bisabolol, Cetearyl Alcohol, Sorbitan Oleate, Retinol, Hydroxypinacolone Retinoate, Myristoyl Nanapeptide-3, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopherol, Sodium Ascorbate, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Sodium Lactate, Ethylhexylglycerin, Isohexadecane, Polysorbate 80, Polysorbate 20, Dimethyl Isosorbide, Xanthan Gum, Carbomer, Disodium EDTA, Sodium Hydroxide, Pentylene Glycol, Chlorphenesin, Phenoxyethanol, Caprylyl Glycol, Citric Acid, Potassium Sorbate, Fragrance.

— FDA label of Advanced Anti-Wrinkle Therapy Cicatricure, Genomma Lab, effective February 18, 2019. See the official label on DailyMed →

Prevage Anti-aging Moisture Cream · Revlon Consumer Products Corp

Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.22% · Oxybenzone 0.5%, cream (topical)

Active ingredient

Section OCTINOXATE 7.5% OCTISALATE 5.0% OXYBENZONE 5.0% OCTOCRYLENE 2.2% AVOBENZONE 2.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin againg caused by the sun

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

Directions

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours

Inactive ingredients

WATER/AQUA/EAU, DIMETHICONE, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, ISOSTEARYL NEOPENTANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, PPG-2 ISOCETETH-20 ACETATE, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, CARBOMER, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, ERGOTHIONEINE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, MICA, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, RETINYL LINOLEATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, SUCROSE, TREHALOSE, TRIDECETH-6, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, IRON OXIDES (CI 77492), RED 4 (CI 14700), TITANIUM DIOXIDE (CI 77891), YELLOW 5 (CI 19140)

— FDA label of Prevage Anti-aging Moisture Cream, Revlon Consumer Products Corp, effective December 29, 2025. See the official label on DailyMed →

Solar Moisturizer SPF 30 · Allure Labs, LLC

Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.15% · Oxybenzone 0.6%, cream (topical)

Active ingredient

Octinoxate - 7.5% Oxybenzone - 6.0% Octisalate - 5.0% Avobenzone - 2.0% Octocrylene - 1.5%

Purpose

Sunscreen

Uses

- This product is suited for broad spectrum UV Protection.

Warnings

- For external use only.

When using this product

- Keep out of eyes. If contact occurs, rinse with water. Discontinue use if irritation or redness occurs. Stop use and ask a doctor - If severe skin irritation develops.

Keep out of reach of children

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

Directions

- Apply using fingertips 20-30 minutes before sun exposure. Gentely massage into face and neck. Reapply as needed. Discontinue use if irritation develops.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Glycerin , Aloe Barbadensis Leaf Juice , Bis(Cyano Butylacetate) Anthracenediylidene, Disodium EDTA, Sorbitan Oleate, Ubiquinone, Teprenone, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate, Yeast Polysaccharides, Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Laminaria Digitata Extract, Artemisia Vulgaris Extract, Echinacea Purpurea Extract, Centella Asiatica Extract , Cyclopentasiloxane, Cyclohexasiloxane, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Triethanolamine , PEG-8, Tocopherol , Ascorbyl Palmitate , Ascorbic Acid , Citric Acid, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Arctostaphylos Uva Ursi Leaf Extract , Mitracarpus Scaber Extract, Plankton Extract , Lecithin , Micrococcus Lysate, Arabidopsis Thaliana Extract , Polygonum Aviculare Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin , Hexylene Glycol, Potassium Sorbate, Sodium Benzoate , Sodium Metabisulfite, Sodium Lactate, Biotin, Xanthan Gum, Benzoic Acid, Fragrance (or) Parfum, Benzyl Alcohol, Benzyl Salicylate, Geraniol, Linalool, Eugenol

— FDA label of Solar Moisturizer SPF 30, Allure Labs, LLC, effective December 5, 2024. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Avobenzone 30 mg/mL · Octinoxate 75 mg/mL · Octisalate 50 mg/mL · Octocrylene 27 mg/mL · Oxybenzone 50 mg/mL · cream (topical) · 3 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Serious Skincare Serious C3 Plasma Bio Technology C Vitamin C Ester Protective Daytime Broad Spectrum Moisturizer Spf 30 Flageoli Limited DailyMed
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30 Flageoli Limited DailyMed
Serious Skincare Serious-C3 Plasma Tm Bio Technology C Vitamin C Ester Protective Daytime Broad Spectrum Moisturizer Spf 30 Flageoli Limited DailyMed
Avobenzone 0.51 g/17 g · Octinoxate 1.28 g/17 g · Octisalate 0.85 g/17 g · Octocrylene 0.85 g/17 g · Oxybenzone 1.02 g/17 g · stick (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Cannon Balm 140 Duke Cannon Supply Co. DailyMed
Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.3% · Oxybenzone 0.4% · emulsion (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Ceramide Premiere Broad Spectrum Spf 30 Revlon DailyMed
Avobenzone 3% · Octinoxate 7.5% · Octisalate 5% · Octocrylene 2.7% · Oxybenzone 4% · cream (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Advanced Anti-Wrinkle Therapy Cicatricure Genomma Lab DailyMed
Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.22% · Oxybenzone 0.5% · cream (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Prevage Anti-aging Moisture Cream Revlon Consumer Products Corp DailyMed
Avobenzone 0.2% · Octinoxate 0.75% · Octisalate 0.5% · Octocrylene 0.15% · Oxybenzone 0.6% · cream (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Solar Moisturizer SPF 30 Allure Labs, LLC DailyMed
Avobenzone 2 mg/mL · Octinoxate 7.5 g/mL · Octisalate 5 mg/mL · Octocrylene 2.2 mg/mL · Oxybenzone 5 mg/mL · lotion (topical) · 1 product
Brand or product nameCompany on the labelLabel
Prevage anti aging SPF 30 Revlon DailyMed
Avobenzone 2% · Octinoxate 7.5% · Octisalate 5% · Octocrylene 7% · Oxybenzone 5% · cream (topical) · 1 product
Brand or product nameCompany on the labelLabel
Ray Defense Broad Spectrum SPF 30 Bioelements —

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Flageoli Limited3 products
  • Revlon2 products
  • Duke Cannon Supply Co.1 product
  • Genomma Lab1 product
  • Revlon Consumer Products Corp1 product
  • Allure Labs, LLC1 product
  • Bioelements1 product

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Next steps

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

Report an error → · Information for medicine makers