Label: FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen cream
- NDC Code(s): 82601-300-01
- Packager: HANS BIOMED S.L.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
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- Official Label (Printer Friendly)
- Active Ingredient Purpose
- Purpose
- Uses
- Warnings
- DO NOT USE
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
-
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 sweatingSun 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
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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.
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- OUTER PACKAGING
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INGREDIENTS AND APPEARANCE
FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50
sunscreen creamProduct 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)