FOTOSKINOX Color Face Cream Sunscreen Broad Spectrum SPF 50

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 Color Face Cream Sunscreen Broad Spectrum SPF 50
Active ingredientENSULIZOLE, OCTINOXATE, AVOBENZONE, 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, reguarlry use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in t...

Label contents#

Full prescribing information#

Active Ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobnzone 3% Sunscreen

Ensulizole 3% Sunscreen

Octinoxate 4% Sunscreen

Octocrylene 2% Sunscreen

Titanium Dioxide 4.8% Sunscreen

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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 Control 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, reguarlry 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. 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 15ºC-30ºC (59ºF-86ºF)

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Dicaprylyl Ether, Propanediol, Squalane, Ethyl Macadamiate, Butylene Glycol, Triethanolamine, Poly C10-30 Alkyl Acrylate, Sodium Polyacrylate, Cetyl Alcohol, Glyceryl Stearate, Phenoxyethanol, Yellow Iron Oxide (CI 77492), Glycerin, Cellulose Acetate, Red Iron Oxide (CI 77491), PEG-75 Stearate, Acrylates/Ammonium Methacrylate Copolymer, Propylene Glycol Stearate, Ceteth-20, Steareth-20, Lecithin, Gossypium Herbaceum Callus Culture, Silica, Ethylhexylglycerin, Magnesium Stearate, Black Iron Oxide (CI 77499), Polygonum Aviculare Extract, Hydrogenated Polydecene, Alteromonas Ferment Extract, Potassium Sorbat, Sodium Benzoate, Trideceth-6, Tocopherol, Citric Acid, Malic Acid, Acetyl Hexapeptide-49, Fragrance, Citronellol, D-Limonene, Geraniol, Linalool.

Questions or comments?

OTC - QUESTIONS SECTION

usa@skymedic.eu

OUTER PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC 82601-300-0150 mL NDC 82601-300-01

back packaging fotoskinox crema COLOR backback packaging fotoskinox crema COLOR back

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82601-30082601-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26cde42c-46a6-2804-e063-6394a90a8102e38d35fa-7b2c-44ad-e053-2a95a90a89082024-11-13WarningsExact identifier
spl set id: e38d35fa-7b2c-44ad-e053-2a95a90a8908

Reported adverse events (FAERS/openFDA)#

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