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Over-the-counter medicine · no prescription needed

Ensulizole, octisalate, octocrylene and zinc oxide

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 Ensulizole, octisalate, octocrylene and zinc oxide used for?
The Drug Facts label of SIMPLI DAY All In One SmartCream SPF 42 (Simpli Skin Md LLC) lists these uses: Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.
Do I need a prescription for Ensulizole, octisalate, octocrylene and zinc oxide?
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 Ensulizole, octisalate, octocrylene and zinc oxide 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.

SIMPLI DAY All In One SmartCream SPF 42 · Simpli Skin Md LLC

Ensulizole 40 mg/mL · Octisalate 50 mg/mL · Octocrylene 50 mg/mL · Zinc oxide 50 mg/mL, cream (topical)

Active ingredient

Zinc Oxide 5% Octisalate 5% Octocrylene 5% Ensulizole 4% Purpose Sunscreen

Purpose

Sunscreen

Uses

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

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 or irritation occurs Keep out of each of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply liberally each morning 15 minutes before sun exposure. During sun exposure, reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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: Sun Protection Measures: 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

Inactive ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Bakuchiol, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ceramide NG, Cetearyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Ethylhexyl Palmitate, Ethylhexylglycerin, Ferulic Acid, I-Glutathione, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydroxypropyl Cyclodextrin, Lamanaria Digitata (Sea Kelp) Extract, Lecithin, Niacinamide, Palmitoyl Tripeptide-38, Panthenol (Vitamin B5), Phenoxyethanol, Plankton Extract, Polyhydroxystearic Acid, Polypodium Leucotomos Extract, Polysorbate-20, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, Zemea (Corn) Propanediol

Questions?

Visit www.simpliskinmd.com

— FDA label of SIMPLI DAY All In One SmartCream SPF 42, Simpli Skin Md LLC, effective November 11, 2023. See the official label on DailyMed →

cle de peau BEAUTE UV PROTECTIVE FOR BODY N · Shiseido Americas Corporation

Ensulizole 2.384% · Octisalate 5.96% · Octocrylene 5.96% · Zinc oxide 23.1248%, emulsion (topical)

Purpose

Active Ingredients Purpose Ensulizole 2.0% Sunscreen Octisalate 5.0% Sunscreen Octocrylene 5.0% Sunscreen Zinc Oxide 19.4% 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

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:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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

Inactive ingredients

Uses WATER・DIMETHICONE・DIISOPROPYL SEBACATE・GLYCERIN・ALCOHOL DENAT.・TRISILOXANE・PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE・SILICA・ISOPROPYL MYRISTATE・DIPHENYLSILOXY PHENYL TRIMETHICONE・ISODODECANE・TRIMETHYLSILOXYSILICATE・TRIETHANOLAMINE・DEXTRIN PALMITATE・TREHALOSE・MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT・RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT・GLYCINE・PEG/PPG-14/7 DIMETHYL ETHER・HYDRANGEA SERRATA LEAF EXTRACT・THYMUS SERPYLLUM EXTRACT・SODIUM ACETYLATED HYALURONATE・AMINOETHANESULFINIC ACID・SODIUM HYALURONATE・TOCOPHERYL ACETATE・ANGELICA ACUTILOBA ROOT EXTRACT・HYDROLYZED CONCHIOLIN PROTEIN・HYDROLYZED SILK・PERILLA OCYMOIDES LEAF EXTRACT・POLYQUATERNIUM-51・PANAX GINSENG ROOT EXTRACT・SAXIFRAGA SARMENTOSA EXTRACT・GINKGO BILOBA LEAF EXTRACT・SCUTELLARIA BAICALENSIS ROOT EXTRACT・GARCINIA MANGOSTANA BARK EXTRACT・DISTEARDIMONIUM HECTORITE・HYDROGEN DIMETHICONE・ISOSTEARIC ACID・BUTYLENE GLYCOL・DISODIUM EDTA・SORBITAN SESQUIISOSTEARATE・ALCOHOL・TOCOPHEROL・BHT・SODIUM METABISULFITE・SYNTHETIC FLUORPHLOGOPITE・THEANINE・SYZYGIUM JAMBOS LEAF EXTRACT・PHENOXYETHANOL・FRAGRANCE・RED 33・YELLOW 5・YELLOW 6・

Questions?

Call toll free 1-800-906-7503

— FDA label of cle de peau BEAUTE UV PROTECTIVE FOR BODY N, Shiseido Americas Corporation, effective December 16, 2025. 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.

Ensulizole 40 mg/mL · Octisalate 50 mg/mL · Octocrylene 50 mg/mL · Zinc oxide 50 mg/mL · cream (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
SIMPLI DAY All In One SmartCream SPF 42 Simpli Skin Md LLC DailyMed
Ensulizole 2.384% · Octisalate 5.96% · Octocrylene 5.96% · Zinc oxide 23.1248% · emulsion (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
cle de peau BEAUTE UV PROTECTIVE FOR BODY N Shiseido Americas Corporation 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.

  • Simpli Skin Md LLC1 product
  • Shiseido Americas Corporation1 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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