FOTOSKINOX FACE CREAM SUNSCREEN- avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide cream 
HANS BIOMED S.L.

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Fotoskinox Face Cream Sunscreen Broad Spectrum SPF 50

Active Ingredient Purpose

Avobenzone 3%

Ensulizole 3%

Octinoxate 4% Sunscreen

Octocrylene 2%

Titanium Dioxide 2.6%

Purpose

Sunscreen

Uses

Warnings

For external use only

Warnings

Do not use on damaged or broken skin

Warnings

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 Center right away.

Directions

For sunscreen use:

Other Information

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

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

Inactive Ingredients

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?

usa@skymedic.eu

OUTER PACKAGING

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

Fotoskinox crema COLOR back

FOTOSKINOX FACE CREAM SUNSCREEN 
avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82601-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.6 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETETH-20 (UNII: I835H2IHHX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GOSSYPIUM HERBACEUM FLOWER (UNII: CVM893280N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SQUALANE (UNII: GW89575KF9)  
STEARETH-20 (UNII: L0Q8IK9E08)  
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MALIC ACID (UNII: 817L1N4CKP)  
ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82601-200-011 in 1 CARTON06/30/2022
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 DrugM02006/30/2022
Labeler - HANS BIOMED S.L. (464035248)
Registrant - AY CONSULTING SERVICES, LLC (078311971)
Establishment
NameAddressID/FEIBusiness Operations
HANS BIOMED , S.L.464035248manufacture(82601-200)

Revised: 1/2024
Document Id: 0f0479c1-813b-822f-e063-6294a90a2c09
Set id: e275d248-2cb6-7185-e053-2a95a90a509e
Version: 2
Effective Time: 20240115
 
HANS BIOMED S.L.