Fotoskinox Face Cream Sunscreen Broad Spectrum SPF 50

Fotoskinox face cream sunscreen by

Drug Labeling and Warnings

Fotoskinox face cream sunscreen by is a Otc medication manufactured, distributed, or labeled by HANS BIOMED S.L., AY CONSULTING SERVICES, LLC, HANS BIOMED , S.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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:

• 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

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: 82601-200-01

FOTOSKINOX FACE CREAM SUNSCREEN 
avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82601-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82601-200-01	1 in 1 CARTON	06/30/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/30/2022	11/13/2024

Labeler - HANS BIOMED S.L. (464035248)

Registrant - AY CONSULTING SERVICES, LLC (078311971)

Establishment
Name	Address	ID/FEI	Business Operations
HANS BIOMED , S.L.		464035248	manufacture(82601-200)

Revised: 11/2024

Document Id: 26cdaa76-e797-0ac9-e063-6394a90afdd6

34390-5

Set id: e275d248-2cb6-7185-e053-2a95a90a509e

Version: 3

Effective Time: 20241113