Label: FARMASI BB- avobenzone, octinoxate, homosalate, octocrylene cream
- NDC Code(s): 78317-056-00
- Packager: TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
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- Official Label (Printer Friendly)
- Drug Facts:
- Active Ingredient:
- Uses:
- Warnings:
-
Directions:
For Sunscreen Use
- Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.
- Reapply atleast every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. Sun Protection Measures:
- 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:
-
Inactive Ingredients:
Water/Aqua, C 12-15 Alkyl Benzoate, Peg-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Silica, Cyclopentasiloxane, Ceteareth-20, Dicaprylyl Carbonate, Ethylhexyl Palmitate, Phenoxyethanol, Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tocopheryl Acetate, Trehalose, Urea, Serine, Pentylene Glycol, Xanthan Gum, Algin, Caprylyl Glycol, Sodium Hyaluronate, Pullulan, Disodium EDTA, Triethanolamine.
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- Package Labeling:
-
INGREDIENTS AND APPEARANCE
FARMASI BB
avobenzone, octinoxate, homosalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78317-056 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.5 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 73.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 97.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 61.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYL PALMITATE (UNII: 2865993309) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) UREA (UNII: 8W8T17847W) SERINE (UNII: 452VLY9402) PENTYLENE GLYCOL (UNII: 50C1307PZG) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM ALGINATE (UNII: C269C4G2ZQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PULLULAN (UNII: 8ZQ0AYU1TT) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78317-056-00 1 in 1 CARTON 10/03/2023 1 150 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 10/03/2023 Labeler - TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (365979587)
