FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen cream

FOTOSKINOX Color Face Cream Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

FOTOSKINOX Color Face Cream Sunscreen Broad Spectrum SPF 50 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]

Active Ingredient Purpose

Avobnzone 3% Sunscreen

Ensulizole 3% Sunscreen

Octinoxate 4% Sunscreen

Octocrylene 2% Sunscreen

Titanium Dioxide 4.8% Sunscreen

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

DO NOT USE

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:

• 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 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

INGREDIENTS AND APPEARANCE

FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82601-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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	4.8 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82601-300-01	1 in 1 CARTON	07/01/2022
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	07/01/2022

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(82601-300)