Label: NOTE BB 500- octinoxate cream
- NDC Code(s): 70474-024-01
- Packager: ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 16, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
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Directions
- 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, regularly 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.-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 (Aqua), Cyclopentasiloxane, PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Mica, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Glycerin, Tocopheryl Acetate, Trimethylsiloxysilicate, Bran ( Triticum vulgare) Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Propylene Glycol, Ethylhexylglycerin, Fragrance (Parfum), Silica, BHT, Bitter Orange( Citrus aurantium) Fruit Extract, Grapefruit ( Citrus paradisi) Fruit Extract, Lecithin, Sorbitol, Sodium Ascorbate, Sunflower ( Helianthus annus) Seed Oil, Tocopherol, Sodium Hydroxide. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
- Package Labeling:
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INGREDIENTS AND APPEARANCE
NOTE BB 500
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70474-024 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) MICA (UNII: V8A1AW0880) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BITTER ORANGE (UNII: DQD16J2B5O) SORBITOL (UNII: 506T60A25R) SODIUM ASCORBATE (UNII: S033EH8359) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM HYDROXIDE (UNII: 55X04QC32I) WHEAT (UNII: 4J2I0SN84Y) GRAPEFRUIT (UNII: O82C39RR8C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70474-024-01 1 in 1 CARTON 01/29/2023 1 30 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 01/29/2023 Labeler - ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI (502657469) Establishment Name Address ID/FEI Business Operations ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI 502657469 manufacture(70474-024)
