Label: SEI BELLA FLAWLESS LIQUID FOUNDATION 540 W- octinoxate 6% octisalate 5% titanium dioxide 2% lotion
- NDC Code(s): 54473-327-01
- Packager: Melaleuca Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- Keep out of reach of children.
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Directions
■ apply after cleanser, toner, and foundation primer. Blend outward with Sei Bella foundation brush or fingers.
■ apply liberally 15 minutes before sun exposure
■ use a water-resistant sunscreen if swimming or sweating
■ reapply at least every 2 hours
■ children under 6 months: ask a doctor
■ Sun Protection Measures. Spending time in the sun increases you 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-sleeve shirts, pants, hats, and sunglasses
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Inactive ingredients
isododecane, water, titanium oxide, dodecane, ethylhexyl palmitate, propanediol, polymethylsilsesquioxane, trimethylsiloxysilicate, peg-10 dimethicone, polysilicone-11, peg/ppg-18/18 dimethicone, dimethicone, barium sulfate, lecithin, glycerin, disteardimonium hectorite, magnesium aluminum silicate, phenoxyethanol, polysorbate 20, c18-36 acid triglyceride, caprylyl glycol, propylene carbonate, triethoxycaprylylsilane, calcium silicate, xanthum gum, cellulose gum, ouptnia ficus-indica stem extract, quartz, palmitoyl hexapeptide-19, may contain: iron oxide CI 77492, iron oxide 77491, iron oxide 77499
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEI BELLA FLAWLESS LIQUID FOUNDATION 540 W
octinoxate 6% octisalate 5% titanium dioxide 2% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-327 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 g in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.8 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.6 g in 30 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYSORBATE 20 (UNII: 7T1F30V5YH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ISODODECANE (UNII: A8289P68Y2) PHENOXYETHANOL (UNII: HIE492ZZ3T) C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PROPYLENE CARBONATE (UNII: 8D08K3S51E) CALCIUM SILICATE (UNII: S4255P4G5M) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) DODECANE (UNII: 11A386X1QH) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPANEDIOL (UNII: 5965N8W85T) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLYSILICONE-15 (UNII: F8DRP5BB29) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE (UNII: 92RU3N3Y1O) BARIUM SULFATE (UNII: 25BB7EKE2E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-327-01 1 in 1 BOX 06/01/2020 1 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2020 Labeler - Melaleuca Inc. (139760102) Registrant - Melaleuca Inc. (139760102) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging LLC. 809172885 manufacture(54473-327)
