Fotoskinox face cream sunscreen

Manufacturer
HANS BIOMED S.L. | AY CONSULTING SERVICES, LLC | HANS BIOMED , S.L.
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:13:53

Label at a glance#

ProductFotoskinox face cream sunscreen
Active ingredientAVOBENZONE, ENSULIZOLE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE
Label structure13 sections

Indications and uses

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

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 this risk, regualrly use a sunscreen with a Broad Spectrum SPF value o 15 or higher and other sun protection measures including: Limit time in th...

Label contents#

Full prescribing information#

Active Ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Ensulizole 3%

Octinoxate 4% Sunscreen

Octocrylene 2%

Titanium Dioxide 2.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Warnings

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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, regualrly use a sunscreen with a Broad Spectrum SPF value o 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. to 2 p.m.
    • Wear long-sleeved shirts, pants, hats and, sunglasses.
    • Children under 6 months of age: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at 15C-30C (59F-86F).

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Butyl Methoxydibenzoylmethane Ethylhexyl Methoxycinnamate, Dicaprylyl Ehter, Phenylbenzimidazole Sulfonic Acid, Propanediol, Squalane, Ethyl Macadamiate, Butylene Glycol, C8-22 Alkyl Acrylates/methacrylic Acid Crosspolymer, Triethanolamine, Cetyl Alcohol, Glyceryl Stearate, Sodium Polyacrylate, Phenoxyethanol, Glycerin, PEG-75 Stearate, Cetheth-20, Steareth-20, Lecithin, Yellow Iron Oxide (CI 77492), Gossypium Herbaceum Callus Culture, Silica, Ehylhexylglycerin, Red Iron Oxide (CI 77491), Polygonum Aviculare Extract, Glack Iron Oxide (CI 77499), Alteromonas Ferment Extract, Citric Acid, Potassium Sorbate, Sodium Benzoate, Tocopherol, Malic Acid, Acetyl Hexapeptide-49, Fragrance, Citronellol, D-Limonelle, Hydroxycitronellal, Linalool, Geraniol.

Questions or comments?

OTC - QUESTIONS SECTION

usa@skymedic.eu

OUTER PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC 82601-200-0150 mL NDC 82601-200-0150 mL NDC 82601-200-01

Fotoskinox crema COLOR backFotoskinox crema COLOR back

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82601-20082601-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26cdaa76-e797-0ac9-e063-6394a90afdd6e275d248-2cb6-7185-e053-2a95a90a509e2024-11-13WarningsExact identifier
spl set id: e275d248-2cb6-7185-e053-2a95a90a509e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.