FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen cream 
HANS BIOMED S.L.

----------

Fotoskinox Color Face Cream Sunscreen Broad Spectrum SPF 50

Active Ingredient Purpose

Avobnzone 3% Sunscreen

Ensulizole 3% Sunscreen

Octinoxate 4% Sunscreen

Octocrylene 2% Sunscreen

Titanium Dioxide 4.8% Sunscreen

Purpose

Sunscreen

Uses

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, reguarlry use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Children under 6 months of age. Ask a doctor.

Other Information

Store at 15ºC-30ºC (59ºF-86ºF)

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

Inactive Ingredients

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?

usa@skymedic.eu

OUTER PACKAGING

50 mL NDC 82601-300-01

back packaging fotoskinox crema COLOR back

FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50 
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82601-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.8 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
SQUALANE (UNII: GW89575KF9)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
GERANIOL (UNII: L837108USY)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETETH-20 (UNII: I835H2IHHX)  
GOSSYPIUM HERBACEUM FLOWER (UNII: CVM893280N)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
STEARETH-20 (UNII: L0Q8IK9E08)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
MALIC ACID (UNII: 817L1N4CKP)  
ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82601-300-011 in 1 CARTON07/01/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/01/2022
Labeler - HANS BIOMED S.L. (464035248)
Registrant - AY CONSULTING SERVICES, LLC (078311971)
Establishment
NameAddressID/FEIBusiness Operations
HANS BIOMED, S.L.464035248manufacture(82601-300)

Revised: 1/2024
Document Id: 0f003e13-aa38-becf-e063-6394a90a95a3
Set id: e38d35fa-7b2c-44ad-e053-2a95a90a8908
Version: 2
Effective Time: 20240115
 
HANS BIOMED S.L.