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Over-the-counter medicine · no prescription needed

Octisalate and octocrylene

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 Octisalate and octocrylene used for?
The Drug Facts label of Leg Body Makeup (Cosmax USA, Corporation) lists these uses: 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 cause by the sun.
Do I need a prescription for Octisalate and octocrylene?
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 Octisalate and octocrylene 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.

Leg Body Makeup · Cosmax USA, Corporation

Octisalate 3.2 mg/100 mg · Octocrylene 6 mg/100 mg, cream (topical)

Active ingredient

Octisalate 3.2% Octocrylene 6.2%

Purpose

Sunscreen

Uses

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 cause by the sun

Warnings

Warnings For extenal 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

Directions 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 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. - 2p.m. -wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor

Other information

Other information protect the product in this container from excessive heat and direct sun QUESTIONS or COMMENTS Questions or comments? 1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

Inactive ingredients

Water,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.

— FDA label of Leg Body Makeup, Cosmax USA, Corporation, effective December 25, 2024. See the official label on DailyMed →

Tone Control Morning Cream SPF 15 · Bentley Laboratories, LLC

Octisalate 2% · Octocrylene 5%, cream (topical)

Active ingredient

DRUG FACTS Active Ingredients Octocrylene 5% Octisalate 2%

Purpose

... Sunscreem

Uses

Helps prevent sunburn.

Warnings

  • Skin Cancer/Skin Aging Alert : Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or early skin aging.
  • 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 the reach of children . If swallowed get medical help or contact a Poison Control center right away.

Directions

  • Apply generously 15 minutes before sun exposure.
  • Use in the morning.
  • Reapply every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Rub cream gently into your face and neck, avoiding the eyes.

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Water, Butyloctyl Salicylate, Cetear- yl Olivate, Sorbitan Olivate, Glyceryl Stearate, Potassium Azeloyl Diglycinate, Glycerin, Niacina- mide, Polyglyceryl-10 Laurate, Sodium Hyaluronate, Silica, Caffeine, Phenoxyethanol, Caprylyl Glycol, Dimethicone, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethyl Ferulate, Ethylhexylglycerin, Arnica Montana Flower Extract

— FDA label of Tone Control Morning Cream SPF 15, Bentley Laboratories, LLC, effective December 27, 2024. See the official label on DailyMed →

lip balm SPF15( CB400) 01 · Cosmuses Cosmetics (Ningbo) Co., Ltd.

Octisalate 4% · Octocrylene 8%, lipstick (topical)

Active ingredient

Octocrylene 8% Octisalate 4%

Purpose

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 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 15minutes before sun exposure Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: Ask a doctor.

Other information

Protect from excessive heat and direct sun.

Inactive ingredients

Beeswax, Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Tocopherol, Phenoxyethanol, Fragrance

— FDA label of lip balm SPF15( CB400) 01, Cosmuses Cosmetics (Ningbo) Co., Ltd., effective March 28, 2025. See the official label on DailyMed →

Leg and Body Makeup Broad Spectrum SPF 25 · Baxter of California, LLC

Octisalate 32 mg/mL · Octocrylene 60 mg/mL, liquid (topical)

Active ingredient

Octisalate 3.2% Octocrylene 6%

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.

Keep out of reach of children

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

Stop use and ask a doctor if

rash occurs

Directions

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 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 of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG 10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions?

1-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

— FDA label of Leg and Body Makeup Broad Spectrum SPF 25, Baxter of California, LLC, effective July 24, 2025. See the official label on DailyMed →

SPF15 lip balm 01 · Cosmuses Cosmetics (Ningbo) Co., Ltd.

Octisalate 2% · Octocrylene 2%, lipstick (topical)

Active ingredient

Octocrylene 2% Octisalate 2%

Purpose

Sunscreen

Uses

Helps prevent sunburn Higher SPF gives more sunburn protection

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. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: 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 time in the sun, especially from 10a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

— FDA label of SPF15 lip balm 01, Cosmuses Cosmetics (Ningbo) Co., Ltd., effective September 8, 2026. See the official label on DailyMed →

Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen · L'Oreal USA Products Inc

Octisalate 32 mg/mL · Octocrylene 60 mg/mL, lotion (topical)

Active ingredient

Octisalate 3.2% Octocrylene 6%

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 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 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 of age: Ask a doctor

Inactive ingredients

water, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions?

1-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

— FDA label of Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen, L'Oreal USA Products Inc, effective December 28, 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.

Octisalate 3.2 mg/100 mg · Octocrylene 6 mg/100 mg · cream (topical) · 12 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Leg Body Makeup Cosmax USA, Corporation DailyMed
Octisalate 2% · Octocrylene 5% · cream (topical) · 3 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Clear System Brightening Day Cream SPF 15 Bentley Laboratories, LLC DailyMed
Tinted Face Cream SPF 15 Bentley Laboratories, LLC DailyMed
Tone Control Morning Cream SPF 15 Bentley Laboratories, LLC DailyMed
Octisalate 4% · Octocrylene 8% · lipstick (topical) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
lip balm SPF15( CB400) 01 Cosmuses Cosmetics (Ningbo) Co., Ltd. DailyMed
SPF15 lip balm 01 Cosmuses Cosmetics (Ningbo) Co., Ltd. DailyMed
Octisalate 32 mg/mL · Octocrylene 60 mg/mL · liquid (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Leg and Body Makeup Broad Spectrum SPF 25 Baxter of California, LLC DailyMed
Octisalate 2% · Octocrylene 2% · lipstick (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
SPF15 lip balm 01 Cosmuses Cosmetics (Ningbo) Co., Ltd. DailyMed
Octisalate 32 mg/mL · Octocrylene 60 mg/mL · lotion (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen L'Oreal USA Products Inc DailyMed

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.

  • Cosmax USA, Corporation12 products
  • Cosmuses Cosmetics (Ningbo) Co., Ltd.3 products
  • Bentley Laboratories, LLC3 products
  • Baxter of California, LLC1 product
  • L'Oreal USA Products Inc1 product

Recalls

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

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.

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